N/A
N=424
Powered Exoskeletons in Persons With SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02658656 ↗Enrolled (actual)
424
Serious AEs
8.9%
Results posted
Jun 2022
Primary outcome: Primary: Improvement on the MCS in All Randomized Participants — 12; 14 Participants — p=0.798
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReWalk 6.0 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement on the MCS in All Randomized Participants |
12; 14 | 0.798 |
| PRIMARY Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants |
10; 11 | 0.935 |
| SECONDARY Total Body Fat Loss in All Randomized Participants |
14; 16 | 0.829 |
| SECONDARY Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase. |
12; 14 | 0.809 |
| SECONDARY Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase. |
10; 11 | 0.717 |
| SECONDARY Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase. |
14; 16 | 0.738 |
| SECONDARY Change in Mental Health Component Summary (MCS) |
1.7; -0.3; 1.0; -1.0; -0.1; -1.8 | — |
| SECONDARY Change in SCI-QOL Physical Medical Health Domain |
-4.4; -0.5; -5.9; -1.7; -6.9; -1.5 | — |
| SECONDARY Change in Total Body Fat |
0.2; 0.3; 0.4; 0.1; 0.1; 0.1 | — |
| SECONDARY Change in SCI-QOL Social Participation Domain |
1.9; -2.0; -0.2; -2.2; 4.1; -3.0 | — |
| SECONDARY Change in SCI-QOL Positive Emotional Constraints |
0.1; -2.3; 1.7; -1.8; 2.6; -3.2 | — |
| SECONDARY Change in SCI-QOL Negative Emotional Constraints |
-6.5; 3.6; -8.4; 1.1; -8.6; 1.5 | — |
| SECONDARY Change in SCI Functional Index (FI) |
5.4; -5.8; 7.3; -4.5; 3.8; -8.6 | — |
| SECONDARY Change in Sleep Disturbance |
-1.8; 2.1; -2.1; 1.6; -0.3; 1.3 | — |
| SECONDARY Change in Participant Impression of Severity |
-0.2; 0.4; 0.0; 0.3; -0.1; 0.3 | — |
| SECONDARY Change in Companion Impression of Severity |
0.0; 0.0; 0.2; 0.3; 0.2; 0.3 | — |
| SECONDARY Bowel Evacuation Time |
14; 8; 10; 14; 10; 22 | — |
| SECONDARY Frequency of Bowel Evacuation Episodes |
18; 23; 7; 9; 16; 16 | — |
| SECONDARY Manual/Digit Stimulation for Bowel Movements |
11; 11; 1; 3; 5; 6 | — |
| SECONDARY Oral Medications for Bowel Movements |
22; 33; 1; 3; 6; 2 | — |
| SECONDARY Enemas or Irrigations for Bowel Movements |
30; 33; 1; 4; 4; 4 | — |
| SECONDARY Bowel Control |
31; 43; 12; 11; 2; 1 | — |
| SECONDARY Stool Consistency |
1; 4; 5; 10; 13; 14 | — |
| SECONDARY Change in Abdominal Fat Mass |
57; 30; 93; 2; 67; 21 | — |
| SECONDARY Change in High Density Lipoprotein Cholesterol |
0.8; -0.6; 1.3; 0.2; 0.7; -0.3 | — |
| SECONDARY Change in Low Density Lipoprotein Cholesterol |
-2.9; 1.2; -0.6; -0.7; -2.4; 1.8 | — |
| SECONDARY Change in Total Cholesterol |
2.9; 0.0; 2.6; 1.4; 4.8; 1.1 | — |
| SECONDARY Change in Triglycerides |
3.9; 4.0; 3.0; 9.5; 14.9; -2.3 | — |
| SECONDARY Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
1.1; 0.1; 2.3; 0.1; 1.7; 0.3 | — |
Summary
Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.
Eligibility Criteria
Inclusion Criteria
- Veterans or active duty military personnel who are at least 18 years of age;
- Traumatic or non-traumatic SCI 6 months duration of SCI;
- Wheelchair-user for indoor and outdoor mobility;
- Anthropometric compatibility with the device:
- Weight 15 degrees at the hip and/or > 10 degrees at the knee;
- Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);
- Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
- Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
- Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
- Pregnancy or women who plan to become pregnant during the study period.
Data sourced from ClinicalTrials.gov (NCT02658656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.