Mobile Manual Standing Wheelchair for SCI

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries and Disorders

• Registration Number: NCT04668326
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Inclusion Criteria:<br><br> - United States Veteran<br><br> - SCI or stable disorder/dysfunction of the spinal cord<br><br> - Tolerates manual wheelchair use on a regular basis<br><br> - Sufficient hand & arm function to operate manual standing wheelchair<br><br> - Unable to stand independently without support<br><br> - Greater than 6 months post-injury (SCI), or 6 months post diagnosis<br> (disorder/dysfunction)<br><br> - Weight less than 125 kg (275 lbs)<br><br> - Age 18 or older<br><br> - Decisional competency to provide consent and cognitive ability to participate fully<br> in study procedures<br><br> - Body size appropriate to fit the devices<br><br> - Not involved in another study related to mobility<br><br> - Identify an appropriate location for use of the study wheelchair<br><br>Exclusion Criteria:<br><br> - Contraindication for standing including lower limb contractures, uncontrolled<br> hypertension, uncontrolled spasticity, etc.<br><br> - Unhealed lower-limb fractures<br><br> - Unstable lower-limb joints<br><br> - An active grade 2 or greater pressure injury that can be worsened by standing in the<br> device<br><br> - Flap procedure to address pressure injury less than one year earlier<br><br> - Not able to propel a manual wheelchair or operate the sit-to-stand mechanism (e.g.<br> weakness, or discomfort)<br><br> - Low bone mineral density (BMD), defined by total hip DXA more than 3.5 SD below peak<br> and/or distal femur/proximal tibia BMD below 0.6 g/cm2. (Low BMD at any site will be<br> ineligible).<br><br> - Unable to obtain clinically acceptable seating system for study wheelchairs<br><br> - Unable to build up standing tolerance within the first eight visits<br><br> - Individual deemed not appropriate for participation in the study as determined by<br> study team

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utility - Measured using the Wheelchair Outcome Measure;Standing Dose - Total time standing - Study Wheelchair;Standing Dose - Total time standing - Existing Standing Device