Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spi… (NCT03989752) | Clinical Trial Compass
TerminatedNot Applicable
Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury
Stopped: COVID-19
Canada16 participantsStarted 2019-03-14
Plain-language summary
Many individuals with a spinal cord injury (SCI) use a wheelchair as their primary mode of locomotion. The prolonged non-active sitting time associated to this mode of locomotion contributes to development or worsening of numerous adverse health effects affecting musculoskeletal, endocrino-metabolic and cardiorespiratory health. To counter this vicious circle, engaging in a walking program with a wearable robotic exoskeleton (WRE) is a promising physical activity intervention. This study aims to measure the effects of a WRE-assisted walking program on musculoskeletal, endocrino-metabolic and cardiorespiratory health.
Who can participate
Age range
18 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:
* Traumatic or non-traumatic spinal cord injury between C6 and T10 neurological level at least 18 months pre-enrollment
* Long-term wheelchair use as primary means of mobility (non-ambulatory)
* Normal cognition (Montreal Cognitive Assessment Score ≥26/30)
* Understand and communicate in English of French
* Reside in the community within 75 km of the research site
Exoskeleton-specific inclusion criteria:
* Body mass ≤100 kg
* Height=1.52-1.93 m
* Pelvis width=30-46 cm
* Thigh length=51-61.4 cm
* Lower leg length=48-63.4 cm
* Standing tolerance ≥30 minutes with full lower extremity weight-bearing
Exclusion Criteria:
* Other neurological impairments aside from those linked to the spinal cord injury (e.g., severe traumatic brain injury)
* Concomitant or secondary musculoskeletal impairments (e.g., hip heterotopic ossification)
* History of lower extremity fracture within the past year
* Unstable cardiovascular or autonomic system
* Pregnancy
* Any other other conditions that may preclude lower extremity weight-bearing, walking, or exercise tolerance in the wearable robotic exoskeleton
Exoskeleton-specific exclusion criteria:
* Inability to sit with hips and knees ≥90° flexion
* Lower extremity passive range of motion limitations (hip flexion contracture ≥5°, knee flexion contracture ≥10°, and dorsiflexion ≤-5° with knee extended)
* Moderate-to-sever lower extremity spasticity (\>3 modified Ashworth score)
* Length discrepancy (≥1.3 or 1.9 cm at the thi…
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
Change in bone mass density (BMD) and architecture in the lower extremity
Timeframe: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
2
Change in body composition
Timeframe: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
3
Change in muscle size
Timeframe: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
4
Change in intramuscular fat infiltration
Timeframe: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
Trial details
NCT IDNCT03989752
SponsorCentre for Interdisciplinary Research in Rehabilitation of Greater Montreal