Mobile Manual Standing Wheelchair for SCI (NCT04668326) | Clinical Trial Compass
CompletedNot Applicable
Mobile Manual Standing Wheelchair for SCI
United States25 participantsStarted 2023-05-01
Plain-language summary
People with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are not able to stand without support. Excessive sitting after SCI is believed to contribute to pressure injuries, pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. The VA has developed, patented, and licensed a mobile manual standing wheelchair (MMSW), and the investigators believe the key feature of being able to wheel around while in a standing position will dramatically change how paralyzed Veterans function in their home and community. If this expanded utility is realized, persons with SCI may naturally spend more time standing and less time sitting. To test these ideas, Veterans with SCI will be randomized to using one of two manual standing wheelchairs at home and in the community for two months.
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:
* United States Veteran
* SCI or stable disorder/dysfunction of the spinal cord
* Tolerates manual wheelchair use on a regular basis
* Sufficient hand \& arm function to operate manual standing wheelchair
* Unable to stand independently without support
* Greater than 6 months post-injury (SCI), or 6 months post diagnosis (disorder/dysfunction)
* Weight less than 125 kg (275 lbs)
* Age 18 or older
* Decisional competency to provide consent and cognitive ability to participate fully in study procedures
* Body size appropriate to fit the devices
* Not involved in another study related to mobility
* Identify an appropriate location for use of the study wheelchair
Exclusion Criteria:
* Contraindication for standing including lower limb contractures, uncontrolled hypertension, uncontrolled spasticity, etc.
* Unhealed lower-limb fractures
* Unstable lower-limb joints
* An active grade 2 or greater pressure injury that can be worsened by standing in the device
* Flap procedure to address pressure injury less than one year earlier
* Not able to propel a manual wheelchair or operate the sit-to-stand mechanism (e.g. weakness, or discomfort)
* Low bone mineral density (BMD), defined by total hip DXA more than 3.5 SD below peak and/or distal femur/proximal tibia BMD below 0.6 g/cm2. (Low BMD at any site will be ineligible).
* Unable to obtain clinically acceptable seating system for study wheelchairs
* Unable to build up standing tolerance within the first eight vis…
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
Utility - Measured using the Wheelchair Outcome Measure
Timeframe: Two months
2
Standing Dose - Total time standing - Study Wheelchair
Timeframe: Two months
3
Standing Dose - Total time standing - Existing Standing Device