Trial Outcomes & Findings for Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS) (NCT NCT04409600)
NCT ID: NCT04409600
Last Updated: 2026-03-06
Results Overview
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
COMPLETED
PHASE2
35 participants
24-months
2026-03-06
Participant Flow
Participant milestones
| Measure |
Home Based Gait Retraining + Saline Injection
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
10
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
7
|
Reasons for withdrawal
| Measure |
Home Based Gait Retraining + Saline Injection
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
2
|
|
Overall Study
Left Active Duty
|
1
|
3
|
4
|
1
|
|
Overall Study
Study ended prior to time point data collection
|
5
|
2
|
0
|
4
|
Baseline Characteristics
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
Baseline characteristics by cohort
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
10 Participants
n=76 Participants
|
10 Participants
n=565 Participants
|
35 Participants
n=196 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
6 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
7 Participants
n=76 Participants
|
9 Participants
n=565 Participants
|
29 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
3 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
5 Participants
n=196 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
7 Participants
n=76 Participants
|
9 Participants
n=565 Participants
|
27 Participants
n=196 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=41 Participants
|
7 participants
n=35 Participants
|
10 participants
n=76 Participants
|
10 participants
n=565 Participants
|
35 participants
n=196 Participants
|
PRIMARY outcome
Timeframe: baselineThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score at Baseline
|
10.86 cumulative score on a 9-item scale
Standard Deviation 5.90
|
11.86 cumulative score on a 9-item scale
Standard Deviation 4.95
|
12.14 cumulative score on a 9-item scale
Standard Deviation 3.44
|
9.75 cumulative score on a 9-item scale
Standard Deviation 5.52
|
PRIMARY outcome
Timeframe: 8-weekThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection
|
14.14 Cumulative Score on a 9-item scale
Standard Deviation 9.30
|
17.71 Cumulative Score on a 9-item scale
Standard Deviation 6.13
|
20.86 Cumulative Score on a 9-item scale
Standard Deviation 7.10
|
15.67 Cumulative Score on a 9-item scale
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: 3-monthThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection
|
13.40 Cumulative score on a 9-item scale
Standard Deviation 8.41
|
14.43 Cumulative score on a 9-item scale
Standard Deviation 6.60
|
20.57 Cumulative score on a 9-item scale
Standard Deviation 4.76
|
15.67 Cumulative score on a 9-item scale
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: 6-monthThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection
|
12.17 Cumulative score on a 9-item scale
Standard Deviation 7.49
|
16.40 Cumulative score on a 9-item scale
Standard Deviation 9.34
|
22.43 Cumulative score on a 9-item scale
Standard Deviation 4.72
|
14.57 Cumulative score on a 9-item scale
Standard Deviation 7.39
|
PRIMARY outcome
Timeframe: 12-monthThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection
|
10.83 Cumulative Score on a 9-item scale
Standard Deviation 6.85
|
21.75 Cumulative Score on a 9-item scale
Standard Deviation 6.31
|
21.00 Cumulative Score on a 9-item scale
Standard Deviation 5.23
|
18.80 Cumulative Score on a 9-item scale
Standard Deviation 13.74
|
PRIMARY outcome
Timeframe: 24-monthThe UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection
|
18.00 Cumulative Score on a 9-item scale
Standard Deviation 0
|
36.00 Cumulative Score on a 9-item scale
Standard Deviation 0
|
13.00 Cumulative Score on a 9-item scale
Standard Deviation 4.58
|
22.33 Cumulative Score on a 9-item scale
Standard Deviation 14.57
|
PRIMARY outcome
Timeframe: baselineA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) Score at Baseline
|
74.44 score on a scale
Standard Deviation 15.09
|
5357 score on a scale
Standard Deviation 19.73
|
58.50 score on a scale
Standard Deviation 12.03
|
44.00 score on a scale
Standard Deviation 16.96
|
PRIMARY outcome
Timeframe: 8-weeksA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection
|
66.29 score on a scale
Standard Deviation 18.50
|
66.43 score on a scale
Standard Deviation 21.55
|
67.50 score on a scale
Standard Deviation 16.71
|
51.88 score on a scale
Standard Deviation 24.49
|
PRIMARY outcome
Timeframe: 3-monthsA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection
|
65.00 score on a scale
Standard Deviation 23.24
|
66.43 score on a scale
Standard Deviation 14.06
|
70.00 score on a scale
Standard Deviation 17.50
|
47.78 score on a scale
Standard Deviation 22.38
|
PRIMARY outcome
Timeframe: 6-monthsA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection
|
60.83 score on a scale
Standard Deviation 23.33
|
71.00 score on a scale
Standard Deviation 28.15
|
76.67 score on a scale
Standard Deviation 20.46
|
61.67 score on a scale
Standard Deviation 25.98
|
PRIMARY outcome
Timeframe: 12-monthsA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection
|
64.17 score on a scale
Standard Deviation 22.89
|
68.75 score on a scale
Standard Deviation 22.98
|
72.00 score on a scale
Standard Deviation 7.58
|
52.14 score on a scale
Standard Deviation 34.38
|
PRIMARY outcome
Timeframe: 24-monthsA patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection
|
90.00 score on a scale
Standard Deviation 0.00
|
100.00 score on a scale
Standard Deviation 0.00
|
51.67 score on a scale
Standard Deviation 7.64
|
76.67 score on a scale
Standard Deviation 25.17
|
PRIMARY outcome
Timeframe: 8-weeksGlobal Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Global Rate of Change Score at 8-weeks Post-Injection
|
1 score on a scale
Standard Deviation 2.31
|
2.43 score on a scale
Standard Deviation 1.40
|
3.20 score on a scale
Standard Deviation 2.25
|
3.00 score on a scale
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: 3-monthsGlobal Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Global Rate of Change Score 3-months Post-Injection
|
2.00 score on a scale
Standard Deviation 3.90
|
1.71 score on a scale
Standard Deviation 2.06
|
3.78 score on a scale
Standard Deviation 1.79
|
1.11 score on a scale
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: 6-monthsGlobal Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Global Rate of Change Score at 6-months Post-Injection
|
1.67 score on a scale
Standard Deviation 3.61
|
3.20 score on a scale
Standard Deviation 2.77
|
5.00 score on a scale
Standard Deviation 1.80
|
1.44 score on a scale
Standard Deviation 3.00
|
PRIMARY outcome
Timeframe: 12-monthsGlobal Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Global Rate of Change Score 12-months Post-Injection
|
0.50 score on a scale
Standard Deviation 4.32
|
3.00 score on a scale
Standard Deviation 1.63
|
3.20 score on a scale
Standard Deviation 2.28
|
2.86 score on a scale
Standard Deviation 2.85
|
PRIMARY outcome
Timeframe: 24-monthsGlobal Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Global Rate of Change Score at 24-months Post-Injection
|
7.00 score on a scale
Standard Deviation 0.00
|
7.00 score on a scale
Standard Deviation 0.00
|
-0.33 score on a scale
Standard Deviation 0.58
|
4.00 score on a scale
Standard Deviation 3.61
|
PRIMARY outcome
Timeframe: baselineQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at Baseline
Limited Duty
|
2 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Duty Status at Baseline
Full Duty
|
6 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 8-weeksQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at 8-weeks Post-Injection
Full Duty
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Duty Status at 8-weeks Post-Injection
Limited Duty
|
3 Participants
|
5 Participants
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 3-monthsQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at 3-months Post-Injection
Full Duty
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Duty Status at 3-months Post-Injection
Limited Duty
|
5 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 6-monthsQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at 6-months Post-Injection
Full Duty
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Duty Status at 6-months Post-Injection
Limited Duty
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12-monthsQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at 12-months Post-Injection
Full Duty
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Duty Status at 12-months Post-Injection
Limited Duty
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24-monthsQuestion asked to military service members about their current duty status.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Duty Status at 24-months Post-Injection
Limited Duty
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Duty Status at 24-months Post-Injection
Full Duty
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: baselineIndividuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at Baseline
|
4.33 score on a scale
Standard Deviation 2.35
|
3.98 score on a scale
Standard Deviation 2.28
|
3.86 score on a scale
Standard Deviation 1.16
|
2.67 score on a scale
Standard Deviation 2.32
|
PRIMARY outcome
Timeframe: 8-weeksIndividuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at 8-weeks Post-Injection
|
5.70 score on a scale
Standard Deviation 2.63
|
4.99 score on a scale
Standard Deviation 2.37
|
5.49 score on a scale
Standard Deviation 1.46
|
4.29 score on a scale
Standard Deviation 2.64
|
PRIMARY outcome
Timeframe: 3-monthsIndividuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at 3-months Post-Injection
|
3.55 score on a scale
Standard Deviation 2.63
|
4.94 score on a scale
Standard Deviation 2.27
|
6.09 score on a scale
Standard Deviation 1.31
|
3.35 score on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: 6-monthsIndividuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at 6-months Post-Injection
|
4.68 score on a scale
Standard Deviation 2.84
|
6.04 score on a scale
Standard Deviation 2.66
|
6.83 score on a scale
Standard Deviation 1.74
|
3.62 score on a scale
Standard Deviation 2.78
|
PRIMARY outcome
Timeframe: 12-monthsIndividuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at 12-months Post-Injection
|
3.57 score on a scale
Standard Deviation 3.47
|
4.46 score on a scale
Standard Deviation 1.68
|
5.67 score on a scale
Standard Deviation 2.09
|
3.90 score on a scale
Standard Deviation 4.05
|
PRIMARY outcome
Timeframe: 24-monthsPopulation: No participants in the HBGR+Saline Injection recorded their PSFS response.
Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Specific Functional Scale Scores at 24-months Post-Injection
|
—
|
10.00 score on a scale
Standard Deviation 0.00
|
4.33 score on a scale
Standard Deviation 0.47
|
5.00 score on a scale
Standard Deviation 4.67
|
PRIMARY outcome
Timeframe: baselineThe Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Balance Error Scoring System Score at Baseline
|
19.11 score on a scale
Standard Deviation 8.31
|
21.14 score on a scale
Standard Deviation 3.67
|
21.60 score on a scale
Standard Deviation 3.55
|
15.70 score on a scale
Standard Deviation 6.50
|
PRIMARY outcome
Timeframe: 8-weeksThe Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Balance Error Scoring System Score at 8-weeks Post-Injection
|
19.71 score on a scale
Standard Deviation 11.33
|
19.29 score on a scale
Standard Deviation 5.41
|
23.50 score on a scale
Standard Deviation 7.17
|
18.50 score on a scale
Standard Deviation 5.90
|
PRIMARY outcome
Timeframe: 3-monthsThe Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Balance Error Scoring System Score at 3-months Post-Injection
|
14.83 score on a scale
Standard Deviation 9.28
|
22.20 score on a scale
Standard Deviation 5.93
|
23.00 score on a scale
Standard Deviation 9.26
|
14.83 score on a scale
Standard Deviation 6.24
|
PRIMARY outcome
Timeframe: 6-monthsThe Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Balance Error Scoring System Score at 6-months Post-Injection
|
19.80 score on a scale
Standard Deviation 12.11
|
22.20 score on a scale
Standard Deviation 5.93
|
23.00 score on a scale
Standard Deviation 9.26
|
18.44 score on a scale
Standard Deviation 8.96
|
PRIMARY outcome
Timeframe: 12-monthsThe Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Balance Error Scoring System Score at 12-months Post-Injection
|
20.50 score on a scale
Standard Deviation 13.44
|
26.50 score on a scale
Standard Deviation 0.71
|
25.50 score on a scale
Standard Deviation 7.72
|
23.67 score on a scale
Standard Deviation 6.83
|
PRIMARY outcome
Timeframe: BaselineUsing wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Gait Analysis - Cadence at Baseline
|
161.22 steps per minute
Standard Deviation 6.56
|
162.14 steps per minute
Standard Deviation 9.25
|
159.80 steps per minute
Standard Deviation 7.21
|
158.60 steps per minute
Standard Deviation 7.00
|
PRIMARY outcome
Timeframe: baselineQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at Baseline
No, not able
|
4 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
|
Ability to Run 2 Miles at Baseline
Yes, pain free and symptom free
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Run 2 Miles at Baseline
Yes, pain free but with symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Run 2 Miles at Baseline
Yes, with pain and symptoms
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 8-weeksQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at 8-weeks Post-Injection
Yes, with pain and symptoms
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 8-weeks Post-Injection
No, not able
|
4 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Ability to Run 2 Miles at 8-weeks Post-Injection
Yes, pain free and symptom free
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 8-weeks Post-Injection
Yes, pain free but with symptoms
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3-monthsQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at 3-months Post-Injection
No, not able
|
2 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Ability to Run 2 Miles at 3-months Post-Injection
Yes, pain free and symptom free
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Ability to Run 2 Miles at 3-months Post-Injection
Yes, pain free but with symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 3-months Post-Injection
Yes, with pain and symptoms
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6-monthsQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at 6-months Post-Injection
No, not able
|
2 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Ability to Run 2 Miles at 6-months Post-Injection
Yes, pain free but with symptoms
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 6-months Post-Injection
Yes, with pain and symptoms
|
4 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 6-months Post-Injection
Yes, pain free and symptom free
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 12-monthsQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at 12-months Post-Injection
No, not able
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Ability to Run 2 Miles at 12-months Post-Injection
Yes, pain free and symptom free
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Ability to Run 2 Miles at 12-months Post-Injection
Yes, pain free but with symptoms
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Run 2 Miles at 12-months Post-Injection
Yes, with pain and symptoms
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24-monthsQuestion asked to military service members about their ability to run 2 miles.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Run 2 Miles at 24-months Post-Injection
No, not able
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 24-months Post-Injection
Yes, pain free and symptom free
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 24-months Post-Injection
Yes, pain free but with symptoms
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Ability to Run 2 Miles at 24-months Post-Injection
Yes, with pain and symptoms
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8-WeeksUsing wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Gait Analysis - Cadence at 8-weeks Post-Injection
|
166.34 steps per minute
Standard Deviation 7.41
|
168.00 steps per minute
Standard Deviation 6.93
|
167.80 steps per minute
Standard Deviation 9.64
|
468.99 steps per minute
Standard Deviation 7.42
|
PRIMARY outcome
Timeframe: 3-monthsUsing wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Gait Analysis - Cadence at 3-months Post-Injection
|
171.61 steps per minute
Standard Deviation 10.90
|
171.34 steps per minute
Standard Deviation 9.77
|
171.71 steps per minute
Standard Deviation 10.29
|
173.60 steps per minute
Standard Deviation 11.61
|
PRIMARY outcome
Timeframe: 6-monthsUsing wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Gait Analysis - Cadence at 6-months Post-Injection
|
167.51 steps per minute
Standard Deviation 11.81
|
175.59 steps per minute
Standard Deviation 6.07
|
170.00 steps per minute
Standard Deviation 12.49
|
169.11 steps per minute
Standard Deviation 12.93
|
PRIMARY outcome
Timeframe: 12-monthsUsing wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Gait Analysis - Cadence at 12-months Post-Injection
|
173.99 steps per minute
Standard Deviation 11.30
|
168.99 steps per minute
Standard Deviation 1.40
|
16799 steps per minute
Standard Deviation 15.24
|
173.01 steps per minute
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: baselineQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at Baseline
No, not able
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Ability to Perform Service Specific Job Tasks at Baseline
Not applicable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at Baseline
Yes, fully able
|
5 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Ability to Perform Service Specific Job Tasks at Baseline
Yes, with limitations/accommodations
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8-weeksQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
No, not able
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
Yes, fully able
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
|
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
Yes, with limitations/accommodations
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3-monthsQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
No, not able
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
Yes, fully able
|
2 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
|
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
Yes with limitations/accommodations
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6-monthsQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
Yes, fully able
|
2 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
No, not able
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
Yes with limitations/accommodations
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12-monthsQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
No, not able
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
Yes, fully able
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
Yes with limitations/accommodations
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24-monthsQuestion that asks the military service member of their ability to perform service specific job tasks.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
Yes with limitations/accommodations
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
No, not able
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
Yes, fully able
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baselinePain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at Baseline
|
7.56 score on a scale
Standard Deviation 2.19
|
4.42 score on a scale
Standard Deviation 3.41
|
7.00 score on a scale
Standard Deviation 1.56
|
7.80 score on a scale
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: 8-weeksPain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at 8-weeks Post-Injection
|
6.14 score on a scale
Standard Deviation 2.97
|
5.57 score on a scale
Standard Deviation 2.44
|
5.40 score on a scale
Standard Deviation 2.37
|
5.75 score on a scale
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: 3-monthsPain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at 3-months Post-Injection
|
6.00 score on a scale
Standard Deviation 3.16
|
4.71 score on a scale
Standard Deviation 2.36
|
5.33 score on a scale
Standard Deviation 1.94
|
5.67 score on a scale
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: 6-monthsPain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at 6-months Post-Injection
|
5.67 score on a scale
Standard Deviation 4.50
|
2.60 score on a scale
Standard Deviation 2.61
|
5.33 score on a scale
Standard Deviation 3.00
|
4.78 score on a scale
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: 12-monthsPain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at 12-months Post-Injection
|
5.17 score on a scale
Standard Deviation 4.67
|
3.50 score on a scale
Standard Deviation 2.89
|
6.40 score on a scale
Standard Deviation 2.70
|
3.00 score on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: 24-monthsPopulation: No participant in the SGR+Saline group provided 24-month data.
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Pain Running 2 Miles at 24-months Post-Injection
|
1.00 score on a scale
Standard Deviation 0.00
|
0 score on a scale
Standard Deviation 0
|
8.33 score on a scale
Standard Deviation 0.58
|
3.67 score on a scale
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: 8-weeksQuestionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=7 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=8 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(5) Fair
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(6) Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(7) Very Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(1) Exceptional
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(3) Very Good
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(2) Excellent
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 8-week Post-Injection
(4) Good
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3-monthsQuestionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(1) Exceptional
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(2) Excellent
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(3) Very Good
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(4) Good
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(5) Fair
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(6) Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Patient Satisfaction of Treatment at 3-months Post-Injection
(7) Very Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-monthsQuestionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=5 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=9 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(1) Exceptional
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(2) Excellent
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(3) Very Good
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(4) Good
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(5) Fair
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(6) Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction of Treatment at 6-months Post-Injection
(7) Very Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-monthsQuestionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=6 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=4 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=5 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=7 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(1) Exceptional
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(2) Excellent
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(3) Very Good
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(4) Good
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(5) Fair
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(6) Poor
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 12-weeks Post-Injection
(7) Very Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24-monthsPopulation: No participant in the HBGR + Saline group gave 24-month response.
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Outcome measures
| Measure |
Home Based Gait Retraining + Saline Injection
n=1 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=1 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=3 Participants
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(1) Exceptional
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(2) Excellent
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(3) Very Good
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(4) Good
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(5) Fair
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(6) Poor
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction of Treatment at 24-months Post-Injection
(7) Very Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Home Based Gait Retraining + Saline Injection
Supervised Gait Retraining + Saline Injection
Home Based Gait Retraining + Botulinum Toxin Injection
Supervised Gait Retraining + Botulinum Toxin Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Home Based Gait Retraining + Saline Injection
n=8 participants at risk
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Saline Injection
n=7 participants at risk
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s).
|
Home Based Gait Retraining + Botulinum Toxin Injection
n=10 participants at risk
Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
Supervised Gait Retraining + Botulinum Toxin Injection
n=10 participants at risk
Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Soreness
|
0.00%
0/8 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/7 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
10.0%
1/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprains
|
0.00%
0/8 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
14.3%
1/7 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
10.0%
1/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
10.0%
1/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Tingling
|
0.00%
0/8 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/7 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
20.0%
2/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/8 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
14.3%
1/7 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Achilles tendon pain
|
0.00%
0/8 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/7 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
10.0%
1/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/10 • 12 months
The definition of adverse event and/or serious event does not differ from the clinicaltrials.gov definitions.
|
Additional Information
Teonette Velasco, Associate Investigator
The Geneva Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place