N/A
N=12
Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02322125 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Physiological Cost Index (PCI) Ratio — 3.34 unit less
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReWalk (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physiological Cost Index (PCI) Ratio |
3.34 | — |
| SECONDARY 10 Meter Walk Test |
0.41; 0.42 | — |
| SECONDARY Max Distance |
1309 | — |
| SECONDARY Limits of Stability - Sitting |
1.6; 4.5 | — |
| SECONDARY Sitting Sway |
-1.59; -1.38 | — |
| SECONDARY McGill Pain Questionnaire |
14.4; 16.2; 11.1 | — |
| SECONDARY Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) |
5.91; 5.57; 6.25 | — |
| SECONDARY Motor Evoked Potentials |
402; 353 | — |
| SECONDARY Change From Baseline in Manual Muscle Test at End of Training |
0.4 | — |
Summary
Powered exoskeletons have emerged recently, promising to offer walking to individuals with severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train walking in individuals with chronic, severe spinal cord injury (SCI). We will determine the characteristics of individuals who most benefit from such training, and identify the neuroplasticity induced by the training. We will further determine the feasibility of the ReWalk for home and community ambulation.
Eligibility Criteria
Inclusion Criteria
- non-progressive spinal cord injury ≥1 year post-injury
- Body height between 5'3" and 6'4"
- Body weight ≤82 kg
- Uses wheelchair as primary mode of mobility
- If able to walk, walks at ≤0.4 m/s
- Arm strength sufficient to control forearm crutches
- Agree to attend intensive training of 1.5 hr/day, 4 days/wk for 14 weeks, plus testing pre and post training of approximately 2 weeks each
Exclusion Criteria
- Contractures at the hip, knee or ankle that interferes with fitting into the ReWalk
- Fractures within the last 2 years
- Osteoporosis in the legs (t-score ≤-3.0)
- Severe postural hypotension
- Severe spasticity that interferes with use of the ReWalk
- Active pressure sores
- Pregnancy
- Severe head injury
- Conditions that preclude intensive exercise (such as high blood pressure)
- Presence of conditions contraindicated for transcranial magnetic stimulation
Data sourced from ClinicalTrials.gov (NCT02322125). 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.