Mobile manual standing wheelchair for veterans with spinal cord injuries
Impact of Mobile Manual Standing Wheelchair on Standing Dosage and Utility
This study tests if a new type of standing wheelchair can help veterans with spinal cord injuries move around more and improve their health by reducing the time they spend sitting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT04668326 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a mobile manual standing wheelchair (MMSW) designed for veterans with spinal cord injuries (SCI). The study will involve 48 veterans who will be randomized to use one of two MMSWs in their home and community settings for two months. The goal is to determine if increased mobility while standing can improve health outcomes by reducing the time spent sitting. The MMSW is designed to be user-friendly, stable, and promote independence, addressing the unique needs of individuals with SCI.
Who should consider this trial
Good fit: Ideal candidates include U.S. veterans with spinal cord injuries who can tolerate manual wheelchair use and have sufficient hand and arm function.
Not a fit: Patients with contraindications for standing, such as uncontrolled spasticity or active pressure injuries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance mobility and overall health for veterans with spinal cord injuries.
How similar studies have performed: While there is existing literature on the adverse effects of prolonged sitting, this specific approach using a mobile manual standing wheelchair is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 visits * Individual deemed not appropriate for participation in the study as determined by study team
Where this trial is running
Palo Alto, California and 1 other locations
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (Recruiting)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Andrew H Hansen, PhD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Andrew H Hansen, PhD
- Email: andrew.hansen2@va.gov
- Phone: (612) 467-2910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.