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 range18 Years
SexALL
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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…
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