Trial Outcomes & Findings for A Novel Mechanics-based Intervention to Improve Post-stroke Stability (NCT NCT02964039)
NCT ID: NCT02964039
Last Updated: 2024-06-03
Results Overview
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Results posted on
2024-06-03
Participant Flow
Participants were recruited and enrolled between February 2017 and October 2019 from a database housed at the Medical University of South Carolina. Individuals in this database had previously experienced a stroke, and had agreed to be contacted for participation in research studies.
Of the 93 participants who were assessed for eligibility, 54 met the study's inclusion criteria and were interested in participating in the intervention. These 54 participants were randomized to one of the three study arms.
Participant milestones
| Measure |
Error Reduction
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
|
Overall Study
Received Allocated Intervention
|
15
|
17
|
14
|
|
Overall Study
COMPLETED
|
14
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
5
|
Reasons for withdrawal
| Measure |
Error Reduction
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Overall Study
Medical reason unrelated to study participation
|
1
|
0
|
3
|
|
Overall Study
Research shutdown due to pandemic
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Here, we present the baseline measures for only those participants who completed the intervention.
Baseline characteristics by cohort
| Measure |
Error Reduction
n=18 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=18 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=18 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13 • n=18 Participants
|
57 years
STANDARD_DEVIATION 13 • n=18 Participants
|
57 years
STANDARD_DEVIATION 14 • n=18 Participants
|
59 years
STANDARD_DEVIATION 14 • n=54 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
24 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
30 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
54 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
21 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
32 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Affected leg
Left leg
|
10 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
29 Participants
n=54 Participants
|
|
Affected leg
Right leg
|
8 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
25 Participants
n=54 Participants
|
|
Time since stroke
|
53 months
STANDARD_DEVIATION 48 • n=18 Participants
|
53 months
STANDARD_DEVIATION 46 • n=18 Participants
|
56 months
STANDARD_DEVIATION 57 • n=18 Participants
|
54 months
STANDARD_DEVIATION 50 • n=54 Participants
|
|
Height
|
66 inches
STANDARD_DEVIATION 4 • n=18 Participants
|
68 inches
STANDARD_DEVIATION 4 • n=18 Participants
|
67 inches
STANDARD_DEVIATION 4 • n=18 Participants
|
67 inches
STANDARD_DEVIATION 4 • n=54 Participants
|
|
Weight
|
187 pounds
STANDARD_DEVIATION 49 • n=18 Participants
|
189 pounds
STANDARD_DEVIATION 44 • n=18 Participants
|
181 pounds
STANDARD_DEVIATION 39 • n=18 Participants
|
186 pounds
STANDARD_DEVIATION 43 • n=54 Participants
|
|
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait
|
0.44 Correlation Coefficient
STANDARD_DEVIATION 0.10 • n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.34 Correlation Coefficient
STANDARD_DEVIATION 0.19 • n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.51 Correlation Coefficient
STANDARD_DEVIATION 0.10 • n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.43 Correlation Coefficient
STANDARD_DEVIATION 0.16 • n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
|
Functional Gait Assessment
|
15.5 Score on a scale
STANDARD_DEVIATION 3.2 • n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
13.8 Score on a scale
STANDARD_DEVIATION 5.2 • n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
13.5 Score on a scale
STANDARD_DEVIATION 5.0 • n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
14.3 Score on a scale
STANDARD_DEVIATION 4.6 • n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
|
Activities-specific Balance Confidence scale
|
65.7 Score on a scale
STANDARD_DEVIATION 22.2 • n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
69.8 Score on a scale
STANDARD_DEVIATION 12.4 • n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
69.3 Score on a scale
STANDARD_DEVIATION 15.3 • n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
68.3 Score on a scale
STANDARD_DEVIATION 16.6 • n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
|
Walking speed (10-meter walk test)
|
0.84 meters per second
STANDARD_DEVIATION 0.21 • n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.73 meters per second
STANDARD_DEVIATION 0.31 • n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.78 meters per second
STANDARD_DEVIATION 0.31 • n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
0.78 meters per second
STANDARD_DEVIATION 0.28 • n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
|
Fall incidence (self reported over previous year)
|
6 Participants
n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
7 Participants
n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
7 Participants
n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
20 Participants
n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
|
Fear of falling (self-reported)
|
5 Participants
n=14 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
7 Participants
n=17 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
4 Participants
n=13 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
16 Participants
n=44 Participants • Here, we present the baseline measures for only those participants who completed the intervention.
|
PRIMARY outcome
Timeframe: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeksPopulation: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
4-week assessment
|
-0.02 Correlation coefficient
Standard Deviation 0.22
|
0.12 Correlation coefficient
Standard Deviation 0.20
|
-0.04 Correlation coefficient
Standard Deviation 0.14
|
|
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
8-week assessment
|
0.05 Correlation coefficient
Standard Deviation 0.15
|
0.11 Correlation coefficient
Standard Deviation 0.20
|
-0.02 Correlation coefficient
Standard Deviation 0.16
|
|
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
12-week assessment
|
0 Correlation coefficient
Standard Deviation 0.08
|
0.08 Correlation coefficient
Standard Deviation 0.18
|
0.01 Correlation coefficient
Standard Deviation 0.12
|
|
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
Follow-up assessment (after 12 weeks)
|
-0.01 Correlation coefficient
Standard Deviation 0.16
|
0.11 Correlation coefficient
Standard Deviation 0.18
|
0 Correlation coefficient
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeksPopulation: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Functional Gait Assessment (Change From Baseline)
4-week assessment
|
0.1 score on a scale
Standard Deviation 1.8
|
1.5 score on a scale
Standard Deviation 2.3
|
1.6 score on a scale
Standard Deviation 2.1
|
|
Functional Gait Assessment (Change From Baseline)
8-week assessment
|
0.8 score on a scale
Standard Deviation 2.3
|
1.9 score on a scale
Standard Deviation 2.7
|
2.5 score on a scale
Standard Deviation 2.8
|
|
Functional Gait Assessment (Change From Baseline)
12-week assessment
|
1.5 score on a scale
Standard Deviation 2.5
|
2.9 score on a scale
Standard Deviation 1.9
|
2.1 score on a scale
Standard Deviation 1.8
|
|
Functional Gait Assessment (Change From Baseline)
Follow-up assessment (after 12 weeks)
|
1.0 score on a scale
Standard Deviation 2.5
|
2.2 score on a scale
Standard Deviation 2.5
|
1.9 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeksPopulation: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Activities-specific Balance Confidence Scale (Change From Baseline)
4-week assessment
|
2.2 score on a scale
Standard Deviation 11.2
|
-0.6 score on a scale
Standard Deviation 6.9
|
3.7 score on a scale
Standard Deviation 10.3
|
|
Activities-specific Balance Confidence Scale (Change From Baseline)
8-week assessment
|
2.5 score on a scale
Standard Deviation 12.9
|
-1.2 score on a scale
Standard Deviation 4.9
|
4.1 score on a scale
Standard Deviation 16.2
|
|
Activities-specific Balance Confidence Scale (Change From Baseline)
12-week assessment
|
6.1 score on a scale
Standard Deviation 16.4
|
2.8 score on a scale
Standard Deviation 6.8
|
5.4 score on a scale
Standard Deviation 12.5
|
|
Activities-specific Balance Confidence Scale (Change From Baseline)
Follow-up assessment (after 12 weeks)
|
8.1 score on a scale
Standard Deviation 14.7
|
4.6 score on a scale
Standard Deviation 7.9
|
3.7 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeksPopulation: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
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|---|---|---|---|
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10-meter Walk Test (Change From Baseline)
Follow-up assessment (after 12 weeks
|
0.01 meters per second
Standard Deviation 0.15
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0.01 meters per second
Standard Deviation 0.11
|
0.01 meters per second
Standard Deviation 0.11
|
|
10-meter Walk Test (Change From Baseline)
4-week assessment
|
0.01 meters per second
Standard Deviation 0.08
|
0.03 meters per second
Standard Deviation 0.08
|
0.03 meters per second
Standard Deviation 0.08
|
|
10-meter Walk Test (Change From Baseline)
8-week assessment
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0.02 meters per second
Standard Deviation 0.10
|
0.04 meters per second
Standard Deviation 0.07
|
0.04 meters per second
Standard Deviation 0.10
|
|
10-meter Walk Test (Change From Baseline)
12-week assessment
|
0.05 meters per second
Standard Deviation 0.14
|
0.02 meters per second
Standard Deviation 0.08
|
0.06 meters per second
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 6 months (during 12 week follow-up period)Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Fall Incidence
|
0.50 Falls per participant
Standard Error 0.20
|
0.29 Falls per participant
Standard Error 0.14
|
0.62 Falls per participant
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 6 months (at completion of 12-week Follow-up period)Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
Self-report statement of whether a participant has a fear of falling
Outcome measures
| Measure |
Error Reduction
n=14 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=17 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=13 Participants
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Fear of Falling
|
4 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Error Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Error Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Activity Matched Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Error Reduction
n=18 participants at risk
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Error Augmentation
n=18 participants at risk
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
|
Activity Matched Control
n=18 participants at risk
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
|
|---|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/18 • Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.
We adhered to guidance provided by the Medical University of South Carolina Institutional Review Board; in order for an event to be classified as a reportable adverse event, it cannot be "the expected natural progression of any underlying disease, disorder, or condition of the subject experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event". While we tracked falls, they are thus not included as adverse events.
|
0.00%
0/18 • Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.
We adhered to guidance provided by the Medical University of South Carolina Institutional Review Board; in order for an event to be classified as a reportable adverse event, it cannot be "the expected natural progression of any underlying disease, disorder, or condition of the subject experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event". While we tracked falls, they are thus not included as adverse events.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.
We adhered to guidance provided by the Medical University of South Carolina Institutional Review Board; in order for an event to be classified as a reportable adverse event, it cannot be "the expected natural progression of any underlying disease, disorder, or condition of the subject experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event". While we tracked falls, they are thus not included as adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place