Trial Outcomes & Findings for The ReWalk Exoskeletal Walking System for Persons With Paraplegia (NCT NCT01454570)
NCT ID: NCT01454570
Last Updated: 2020-08-25
Results Overview
1\. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
ReWalk training at 4 and 12 weeks, and 1-month follow-up
Results posted on
2020-08-25
Participant Flow
All participants were recruited, consented, screened and eligible subjects were enrolled at the James J Peters VAMC
Participant milestones
| Measure |
Exoskeleton
Participants trained to use powered exoskeleton for overground ambulation.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Exoskeleton
Participants trained to use powered exoskeleton for overground ambulation.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Screen Failure
|
7
|
Baseline Characteristics
The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Baseline characteristics by cohort
| Measure |
Exoskeleton
n=10 Participants
Trained to use powered exoskeleton for overground ambulation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ReWalk training at 4 and 12 weeks, and 1-month follow-upPopulation: number of participants that were able to achieve the mile stone described in outcome measure description
1\. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes.
Outcome measures
| Measure |
Exoskeleton
n=12 Participants
Trained to use powered exoskeleton for overground ambulation
|
|---|---|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (12 weeks) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (1 mo FU) · Passed
|
10 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (12 weeks) · Not Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (1 mo FU) · Not Tested
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (4 weeks) · Passed
|
9 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (4 weeks) · Not Passed
|
3 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (4 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (12 weeks) · Passed
|
10 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (12 weeks) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (12 weeks) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (1 month follow-up) · Passed
|
9 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (1 month follow-up) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance sit-to-stand (1 month follow-up) · Not Tested
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (4 week) · Passed
|
9 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (4 week) · Not Passed
|
3 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (4 week) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (12 week) · Passed
|
10 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (12 week) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (12 week) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (1 month follow-up) · Passed
|
9 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (1 month follow-up) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance stand-to-sit (1 month follow-up) · Not Tested
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (4 weeks) · Passed
|
11 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (4 weeks) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (4 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (12 weeks) · Passed
|
11 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (12 weeks) · Not Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (12 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (1 mo FU) · Passed
|
11 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (1 mo FU) · Not Passed
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 2 crutches 1 min (1 mo FU) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (4 weeks) · Passed
|
10 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (4 weeks) · Not Passed
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (4 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (12 weeks) · Passed
|
11 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (12 weeks) · Not Passed
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (1 mo FU) · Not Passed
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assist standing 1 crutch 30 sec (1 mo FU) · Not Tested
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (4 weeks) · Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (4 weeks) · Not Passed
|
8 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (4 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (12 weeks) · Passed
|
7 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (12 weeks) · Not Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (12 weeks) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (1 mo FU) · Passed
|
6 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (1 mo FU) · Not Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance 10 walk in ≤2 min (1 mo FU) · Not Tested
|
2 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (4 weeks) · Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (4 weeks) · Not Passed
|
8 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (4 weeks) · Not Tested
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (12 weeks) · Passed
|
7 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (12 weeks) · Not Tested
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (1 mo FU) · Passed
|
6 Participants
|
|
Count to Achieve Mobility Skills
No assistance walk ≥30 meters in 6-min (1 mo FU) · Not Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (4 weeks) · Passed
|
1 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (4 weeks) · Not Passed
|
3 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (4 weeks) · Not Tested
|
8 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (12 weeks) · Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (12 weeks) · Not Passed
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (12 weeks) · Not Tested
|
8 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (1 mo FU) · Passed
|
4 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (1 mo FU) · Not Passed
|
0 Participants
|
|
Count to Achieve Mobility Skills
No assistance ascend and descend stairs (1 mo FU) · Not Tested
|
8 Participants
|
Adverse Events
Exoskeleton
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exoskeleton
n=12 participants at risk
Participants trained to use powered exoskeleton for overground ambulation.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Abrasion / bruising /redness
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
R Medial Malleolus Redness
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
L Lateral Malleolus Skin Abraision
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Tailbone Skin Breakdown
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
R Ischial Area Abasion
|
8.3%
1/12 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
L Medial Malleolus Abrasion
|
8.3%
1/12 • Number of events 1 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place