Trial Outcomes & Findings for Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2) (NCT NCT03082898)
NCT ID: NCT03082898
Last Updated: 2022-02-16
Results Overview
Measure of mobility (specifically gait speed) while wearing exoskeleton
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)
Results posted on
2022-02-16
Participant Flow
Of the 41 participants enrolled, 2 were scheduled to start assessments in Tampa, but the study was cancelled due to COVID and not restarted at the Tampa site.
Participant milestones
| Measure |
AIS A or B Using Indego Exoskeleton
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
AIS C or D Using Indego Exoskeleton
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
12
|
|
Overall Study
COMPLETED
|
24
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AIS A or B Using Indego Exoskeleton
n=24 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
AIS C or D Using Indego Exoskeleton
n=11 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
11 Participants
n=11 Participants
|
35 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=24 Participants
|
3 Participants
n=11 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=24 Participants
|
8 Participants
n=11 Participants
|
27 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)Population: * One participant in the 'AIS A or B using Indego Exoskeleton' group missed the clinic visit for session 24 and we were unable to capture the 10MWT from this participant. * One participant in the 'AIS C or D using Indego Exoskeleton' group missed the clinic visit for session 11 and we were unable to capture the 10MWT from this participant.
Measure of mobility (specifically gait speed) while wearing exoskeleton
Outcome measures
| Measure |
AIS A or B Using Indego Exoskeleton
n=24 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
AIS C or D Using Indego Exoskeleton
n=11 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
|---|---|---|
|
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
10MWT at Session 11 (Week 5)
|
38.3 Seconds
Interval 33.7 to 49.1
|
28.0 Seconds
Interval 24.7 to 35.8
|
|
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
10MWT at Session 16 (Week 6)
|
37.2 Seconds
Interval 31.4 to 43.0
|
27.9 Seconds
Interval 25.0 to 33.4
|
|
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
10MWT at Session 24 (Week 9)
|
34.3 Seconds
Interval 30.3 to 44.3
|
28.6 Seconds
Interval 26.9 to 32.3
|
|
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
10MWT at Session 29 (Week 11)
|
32.6 Seconds
Interval 28.5 to 36.0
|
28.9 Seconds
Interval 27.5 to 31.7
|
PRIMARY outcome
Timeframe: Session 16 (Week 6) and Session 29 (Week 11)Measure of gait speed over six minutes while wearing exoskeleton
Outcome measures
| Measure |
AIS A or B Using Indego Exoskeleton
n=24 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
AIS C or D Using Indego Exoskeleton
n=11 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
|---|---|---|
|
The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)
6MWT at Session 16 (Week 6)
|
288.9 Feet
Interval 223.0 to 332.0
|
379 Feet
Interval 329.0 to 470.0
|
|
The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)
6MWT at Session 29 (Week 11)
|
297 Feet
Interval 250.0 to 368.0
|
390 Feet
Interval 341.0 to 400.0
|
SECONDARY outcome
Timeframe: Session 15 (Week 6), and Session 28 (Week 10)Measure of ability to stand, walk, turn, and sit while wearing exoskeleton
Outcome measures
| Measure |
AIS A or B Using Indego Exoskeleton
n=24 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
AIS C or D Using Indego Exoskeleton
n=11 Participants
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking.
|
|---|---|---|
|
Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test
TUG test at Session 15 (Week 6)
|
87.2 Seconds
Interval 67.0 to 108.0
|
66 Seconds
Interval 61.6 to 93.1
|
|
Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test
TUG test at Session 28 (Week 10)
|
84.3 Seconds
Interval 61.9 to 98.5
|
61.5 Seconds
Interval 55.8 to 76.0
|
Adverse Events
AIS A or B Using Indego Exoskeleton
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AIS C or D Using Indego Exoskeleton
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place