Trial Outcomes & Findings for Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (NCT NCT04340063)
NCT ID: NCT04340063
Last Updated: 2025-05-29
Results Overview
The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Results posted on
2025-05-29
Participant Flow
38 participants signed the consent form. Out of 38, 2 participants were excluded as they did not meet the inclusion criteria at in person screening and were not assigned to any group.
Participant milestones
| Measure |
Treadmill Group
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
Movement Amplification Group
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
Pre-training Assessment
|
18
|
18
|
|
Overall Study
Mid-training Assessment
|
14
|
16
|
|
Overall Study
Post-training Assessment
|
14
|
16
|
|
Overall Study
Follow-up Assessment
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Treadmill Group
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
Movement Amplification Group
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Treadmill Group High Initial Function
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without any forces applied (control group).
|
Movement Amplification Group High Initial Function
n=18 Participants
The locomotor training protocol described for the Treadmill group and stratified into high initial function (who walk ≥0.5m/s without the use of any assistive device) will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
Gait training performed in a Movement Amplification Environment: The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
53.44 years
STANDARD_DEVIATION 19.79 • n=99 Participants
|
54.61 years
STANDARD_DEVIATION 17.52 • n=107 Participants
|
54.03 years
STANDARD_DEVIATION 18.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Time Since Injury
|
10.56 years
STANDARD_DEVIATION 14.96 • n=99 Participants
|
7.94 years
STANDARD_DEVIATION 8.83 • n=107 Participants
|
9.25 years
STANDARD_DEVIATION 12.18 • n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed.
The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Functional Gait Assessment (FGA)
Pre-training assessment
|
14.22 score on a scale
Standard Deviation 7.61
|
15.22 score on a scale
Standard Deviation 7.82
|
|
Functional Gait Assessment (FGA)
Mid-training assessment
|
18.13 score on a scale
Standard Deviation 7.16
|
19.38 score on a scale
Standard Deviation 7.31
|
|
Functional Gait Assessment (FGA)
Post-training assessment
|
19.88 score on a scale
Standard Deviation 7.64
|
20.29 score on a scale
Standard Deviation 7.94
|
|
Functional Gait Assessment (FGA)
Follow-up assessment
|
21.00 score on a scale
Standard Deviation 7.87
|
20.57 score on a scale
Standard Deviation 8.08
|
PRIMARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 35 participants were analyzed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.
Outcome measures
| Measure |
Movement Amplification Group
n=17 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Lateral Center of Mass Excursion
Pre-training assessment
|
9.82 centimeters
Standard Deviation 3.68
|
10.16 centimeters
Standard Deviation 4.5
|
|
Lateral Center of Mass Excursion
Mid-training assessment
|
7.42 centimeters
Standard Deviation 2.39
|
8.51 centimeters
Standard Deviation 3.75
|
|
Lateral Center of Mass Excursion
Post-training assessment
|
7.19 centimeters
Standard Deviation 2.23
|
8.43 centimeters
Standard Deviation 4.35
|
|
Lateral Center of Mass Excursion
Follow-up assessment
|
7.38 centimeters
Standard Deviation 1.73
|
8.73 centimeters
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed. 1 participant's data not collected at Baseline but included in later assessment periods.
The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Daily Stepping
Pre-training assessment
|
3,264 Average steps per day
Standard Deviation 3,081
|
5,680 Average steps per day
Standard Deviation 4,945
|
|
Daily Stepping
Post-training assessment
|
4,284 Average steps per day
Standard Deviation 3,039
|
5,480 Average steps per day
Standard Deviation 4,792
|
|
Daily Stepping
Follow-up assessment
|
3,530 Average steps per day
Standard Deviation 2,524
|
6,041 Average steps per day
Standard Deviation 4,421
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The 10MWT is a simple measurement of an individuals average walking speed.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
10 Meter Walk Test (10MWT)_Fast Speed
Pre-training assessment
|
0.87 meter per second
Standard Deviation 0.52
|
0.86 meter per second
Standard Deviation 0.51
|
|
10 Meter Walk Test (10MWT)_Fast Speed
Mid-training assessment
|
1.01 meter per second
Standard Deviation 0.53
|
1.14 meter per second
Standard Deviation 0.68
|
|
10 Meter Walk Test (10MWT)_Fast Speed
Post-training assessment
|
1.08 meter per second
Standard Deviation 0.48
|
1.15 meter per second
Standard Deviation 0.61
|
|
10 Meter Walk Test (10MWT)_Fast Speed
Follow-up assessment
|
1.09 meter per second
Standard Deviation 0.51
|
1.16 meter per second
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The 10MWT is a simple measurement of an individuals average walking speed.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
10 Meter Walk Test (10MWT)_Preferred Speed
Pre-training assessment
|
0.65 meter per second
Standard Deviation 0.38
|
0.65 meter per second
Standard Deviation 0.40
|
|
10 Meter Walk Test (10MWT)_Preferred Speed
Mid-training assessment
|
0.72 meter per second
Standard Deviation 0.38
|
0.83 meter per second
Standard Deviation 0.45
|
|
10 Meter Walk Test (10MWT)_Preferred Speed
Post-training assessment
|
0.79 meter per second
Standard Deviation 0.35
|
0.83 meter per second
Standard Deviation 0.41
|
|
10 Meter Walk Test (10MWT)_Preferred Speed
Follow-up assessment
|
0.81 meter per second
Standard Deviation 0.37
|
0.84 meter per second
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: At post-training assessment, a total of 30 participants analyzed corresponds to those who completed intervention and post-training assessment. At follow up, a total of 28 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Activities Specific Balance Confidence (ABC) Scale
Pre-training assessment
|
65.39 score on a scale
Standard Deviation 21.14
|
62.62 score on a scale
Standard Deviation 22.96
|
|
Activities Specific Balance Confidence (ABC) Scale
Mid-training assessment
|
75 score on a scale
Standard Deviation 16.32
|
71.97 score on a scale
Standard Deviation 22.94
|
|
Activities Specific Balance Confidence (ABC) Scale
Post-training assessment
|
74.06 score on a scale
Standard Deviation 16.82
|
73.50 score on a scale
Standard Deviation 25.46
|
|
Activities Specific Balance Confidence (ABC) Scale
Follow-up assessment
|
77.32 score on a scale
Standard Deviation 15.89
|
75.46 score on a scale
Standard Deviation 24.77
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The BESTest is used to assess balance impairments across six different domains of postural control. We will use only the reactive balance item from the BESTest to assess changes in the capacity to react to fore-aft, and lateral perturbations. Each item will be scored on a range from 0 (severe impairment) to 3 (no impairment). Highest score is 6 and lowest possible score is 0. Higher score indicates better ability to restore balance and better reactive stepping response during standing perturbation.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Balance Evaluations Systems Test (BESTest)
Pre-training assessment
|
1.88 units on a scale
Standard Deviation 1.71
|
2.64 units on a scale
Standard Deviation 1.98
|
|
Balance Evaluations Systems Test (BESTest)
Mid-training assessment
|
2.13 units on a scale
Standard Deviation 1.93
|
2.92 units on a scale
Standard Deviation 2.14
|
|
Balance Evaluations Systems Test (BESTest)
Post-training assessment
|
2.40 units on a scale
Standard Deviation 2.23
|
2.79 units on a scale
Standard Deviation 2.42
|
|
Balance Evaluations Systems Test (BESTest)
Follow-up assessment
|
2.71 units on a scale
Standard Deviation 2.27
|
3.14 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Berg Balance Scale (BBS)
Pre-training assessment
|
41.67 score on a scale
Standard Deviation 13.78
|
41.78 score on a scale
Standard Deviation 11.95
|
|
Berg Balance Scale (BBS)
Mid-training assessment
|
46.63 score on a scale
Standard Deviation 9.96
|
45.46 score on a scale
Standard Deviation 11.09
|
|
Berg Balance Scale (BBS)
Post-training assessment
|
48.38 score on a scale
Standard Deviation 8.76
|
46.79 score on a scale
Standard Deviation 9.68
|
|
Berg Balance Scale (BBS)
Follow-up assessment
|
48.64 score on a scale
Standard Deviation 8.98
|
47.43 score on a scale
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The ICIQ-UI SF is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Pre-training assessment
|
4.19 score on a scale
Standard Deviation 5.36
|
4.43 score on a scale
Standard Deviation 5.2
|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Mid-training assessment
|
3.63 score on a scale
Standard Deviation 4.6
|
3.21 score on a scale
Standard Deviation 4.51
|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Post-training assessment
|
4.31 score on a scale
Standard Deviation 5.31
|
4.07 score on a scale
Standard Deviation 5.08
|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Follow-up assessment
|
4.57 score on a scale
Standard Deviation 5.43
|
3.71 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed.
The lower extremity motor score assess strength of five muscle groups representing neurological levels L2 to S1. Muscle function is grade on a range from 0 (total paralysis) to 5 (active movement, full range of motion (ROM) against gravity and sufficient resistance to be considered normal. Total score is 50. Higher score indicates better or more complete motor function in the lower extremities. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Lower Extremity Motor Score
Pre-training assessment
|
40.39 score on a scale
Standard Deviation 6.06
|
39.33 score on a scale
Standard Deviation 7.90
|
|
Lower Extremity Motor Score
Mid-training assessment
|
40.88 score on a scale
Standard Deviation 6.24
|
41.14 score on a scale
Standard Deviation 7.23
|
|
Lower Extremity Motor Score
Post-training assessment
|
41.44 score on a scale
Standard Deviation 6.16
|
41.71 score on a scale
Standard Deviation 7.22
|
|
Lower Extremity Motor Score
Follow-up assessment
|
42 score on a scale
Standard Deviation 5.91
|
42 score on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Timed Up and Go (TUG)
Pre-training assessment
|
33.92 seconds
Standard Deviation 39.28
|
34.18 seconds
Standard Deviation 41.94
|
|
Timed Up and Go (TUG)
Mid-training assessment
|
27.51 seconds
Standard Deviation 32.55
|
21.49 seconds
Standard Deviation 24.4
|
|
Timed Up and Go (TUG)
Post-training assessment
|
25.85 seconds
Standard Deviation 36.82
|
23.59 seconds
Standard Deviation 35.11
|
|
Timed Up and Go (TUG)
Follow-up assessment
|
24.67 seconds
Standard Deviation 28.59
|
21.24 seconds
Standard Deviation 28.99
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed.
The WISCI II evaluates the amount of physical assistance needed for gait after spinal cord injury. The index ranges from 0 (client is unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters). Highest score is 20 and lowest possible score is 0. Higher score indicates better ability to ambulate at least a distance of 10 meters without assistance from assistive device and/or from other person.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Walking Index for Spinal Cord Injury II (WISCI II)
Pre-training assessment
|
14.89 score on a scale
Standard Deviation 4.65
|
16.17 score on a scale
Standard Deviation 3.82
|
|
Walking Index for Spinal Cord Injury II (WISCI II)
Mid-training assessment
|
16.25 score on a scale
Standard Deviation 3.86
|
17.57 score on a scale
Standard Deviation 2.44
|
|
Walking Index for Spinal Cord Injury II (WISCI II)
Post-training assessment
|
16.94 score on a scale
Standard Deviation 3.79
|
18.00 score on a scale
Standard Deviation 2.29
|
|
Walking Index for Spinal Cord Injury II (WISCI II)
Follow-up assessment
|
17.21 score on a scale
Standard Deviation 4.10
|
18.21 score on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The physical domain focuses on patients perception about his physical health including items related to mobility, daily activities, functional capacity, energy, pain, and sleep. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
Pre-training assessment
|
62.63 score on a scale
Standard Deviation 18.44
|
74.29 score on a scale
Standard Deviation 18.56
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
Mid-training assessment
|
55.69 score on a scale
Standard Deviation 21.26
|
71.57 score on a scale
Standard Deviation 17.66
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
Post-training assessment
|
65.06 score on a scale
Standard Deviation 23.31
|
73.79 score on a scale
Standard Deviation 14.25
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
Follow-up assessment
|
59.57 score on a scale
Standard Deviation 21.01
|
73.79 score on a scale
Standard Deviation 20.02
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The psychological domain focuses on patients perception about their psychological well-being, encompassing aspects like self-image, negative and positive feelings, self-esteem, and mental status. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
Pre-training assessment
|
66.50 score on a scale
Standard Deviation 16.94
|
76.00 score on a scale
Standard Deviation 18.42
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
Mid-training assessment
|
64.19 score on a scale
Standard Deviation 22.81
|
75.93 score on a scale
Standard Deviation 12.87
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
Post-training assessment
|
70.81 score on a scale
Standard Deviation 22.26
|
78.07 score on a scale
Standard Deviation 10.62
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
Follow-up assessment
|
65.64 score on a scale
Standard Deviation 20.87
|
76.79 score on a scale
Standard Deviation 14.56
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The social relations domain focuses on patients perception about their social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
Pre-training assessment
|
60.56 score on a scale
Standard Deviation 25.28
|
69.21 score on a scale
Standard Deviation 21.18
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
Mid-training assessment
|
62.94 score on a scale
Standard Deviation 20.61
|
66.07 score on a scale
Standard Deviation 18.70
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
Post-training assessment
|
57.81 score on a scale
Standard Deviation 25.41
|
65.46 score on a scale
Standard Deviation 17.47
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
Follow-up assessment
|
59.79 score on a scale
Standard Deviation 19.46
|
71.43 score on a scale
Standard Deviation 18.48
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The environment domain focuses on patients perception about their surroundings, including factors like financial resources, safety, access to services, home environment, and the physical environment. social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
Pre-training assessment
|
79.44 score on a scale
Standard Deviation 16.65
|
80.50 score on a scale
Standard Deviation 19.40
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
Mid-training assessment
|
75.63 score on a scale
Standard Deviation 20.44
|
77.86 score on a scale
Standard Deviation 19.10
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
Post-training assessment
|
77.06 score on a scale
Standard Deviation 19.72
|
80.93 score on a scale
Standard Deviation 18.95
|
|
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
Follow-up assessment
|
73.36 score on a scale
Standard Deviation 19.13
|
84.00 score on a scale
Standard Deviation 16.82
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 35 participants were analyzed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking.
Outcome measures
| Measure |
Movement Amplification Group
n=17 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Minimum Lateral Margin of Stability
Pre-training assessment
|
4.96 centimeters
Standard Deviation 2.4
|
5.84 centimeters
Standard Deviation 2.78
|
|
Minimum Lateral Margin of Stability
Mid-training assessment
|
5.0 centimeters
Standard Deviation 3.23
|
6.16 centimeters
Standard Deviation 2.15
|
|
Minimum Lateral Margin of Stability
Post-training assessment
|
4.73 centimeters
Standard Deviation 3.48
|
6.33 centimeters
Standard Deviation 2.39
|
|
Minimum Lateral Margin of Stability
Follow-up assessment
|
5.39 centimeters
Standard Deviation 3.42
|
6.32 centimeters
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average peak lateral center of mass speed occurring each stride during treadmill walking.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Peak Lateral Center of Mass Speed
Pre-training assessment
|
0.22 centimeters per second
Standard Deviation 0.12
|
0.25 centimeters per second
Standard Deviation 0.14
|
|
Peak Lateral Center of Mass Speed
Mid-training assessment
|
0.23 centimeters per second
Standard Deviation 0.1
|
0.29 centimeters per second
Standard Deviation 0.13
|
|
Peak Lateral Center of Mass Speed
Post-training assessment
|
0.27 centimeters per second
Standard Deviation 0.13
|
0.29 centimeters per second
Standard Deviation 0.15
|
|
Peak Lateral Center of Mass Speed
Follow-up assessment
|
0.24 centimeters per second
Standard Deviation 0.1
|
0.29 centimeters per second
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed.
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step width (lateral distance between calcaneal markers) during treadmill walking.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Step Width
Pre-training assessment
|
0.26 meters
Standard Deviation 0.06
|
0.27 meters
Standard Deviation 0.05
|
|
Step Width
Mid-training assessment
|
0.24 meters
Standard Deviation 0.06
|
0.26 meters
Standard Deviation 0.04
|
|
Step Width
Post-training assessment
|
0.25 meters
Standard Deviation 0.06
|
0.26 meters
Standard Deviation 0.04
|
|
Step Width
Follow-up assessment
|
0.26 meters
Standard Deviation 0.06
|
0.26 meters
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)Population: A total of 36 participants were analyzed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking.
Outcome measures
| Measure |
Movement Amplification Group
n=18 Participants
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
Treadmill Group
n=18 Participants
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without forces applied (control group).
|
|---|---|---|
|
Step Length
Pre-training assessment
|
0.28 meters
Standard Deviation 0.16
|
0.27 meters
Standard Deviation 0.12
|
|
Step Length
Mid-training assessment
|
0.41 meters
Standard Deviation 0.11
|
0.37 meters
Standard Deviation 0.15
|
|
Step Length
Post-training assessment
|
0.45 meters
Standard Deviation 0.13
|
0.41 meters
Standard Deviation 0.17
|
|
Step Length
Follow-up assessment
|
0.43 meters
Standard Deviation 0.14
|
0.39 meters
Standard Deviation 0.15
|
Adverse Events
Treadmill Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Movement Amplification Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treadmill Group
n=18 participants at risk
Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill.
Gait training performed on a treadmill: Participants randomized to the Control group will complete high intensity gait training on a treadmill.
|
Movement Amplification Group
n=18 participants at risk
The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
Gait training performed in a Movement Amplification Environment: The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
|
|---|---|---|
|
Cardiac disorders
Cardiovascular Issues
|
5.6%
1/18 • Number of events 1 • Adverse event data were monitored for each participant for an average of 6 months.
|
5.6%
1/18 • Number of events 1 • Adverse event data were monitored for each participant for an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Injury / Pain
|
11.1%
2/18 • Number of events 2 • Adverse event data were monitored for each participant for an average of 6 months.
|
11.1%
2/18 • Number of events 2 • Adverse event data were monitored for each participant for an average of 6 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place