Status:
ACTIVE_NOT_RECRUITING
Mobile Manual Standing Wheelchair for SCI
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injuries and Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 co...
Detailed Description
Background - The investigators contend that for Veterans with SCI to stand enough to impact health outcomes, the standing device must enhance utility while integrating into their everyday life; at hom...
Eligibility Criteria
Inclusion
- 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
- 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 visits
- Individual deemed not appropriate for participation in the study as determined by study team
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04668326
Start Date
May 1 2023
End Date
March 31 2026
Last Update
October 14 2025
Active Locations (2)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
2
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309