Impact of Mobile Manual Standing Wheelchair on Standing Dosage and Utility

Status: Not yet recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Veterans with spinal cord injury between C7 and T12 (AIS A-C)

• Unable to stand independently without support

• Greater than 6 months post-injury

• Mass less than 125 kg

• 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

Locations
United States
California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis
Contact Information
Primary
Andrew H Hansen, PhD
andrew.hansen2@va.gov
(612) 467-2910
Backup
Patricia McCracken, DPT
Patricia.McCracken@va.gov
(612) 725-2000
Time Frame
Start Date: February 1, 2023
Estimated Completion Date: August 31, 2025
Participants
Target number of participants: 48
Treatments
Active Comparator: Manual Standing Wheelchair
Mobile in seated position; Not mobile in standing position
Experimental: Mobile Manual Standing Wheelchair
Mobile in BOTH seated and standing positions
Authors
B. Jenny Kiratli, Andrew H Hansen
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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