Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury (NCT02322125) | Clinical Trial Compass
CompletedNot Applicable
Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Canada12 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physiological Cost Index (PCI) Ratio
Timeframe: End of training:12-14 weeks from baseline