| NCT ID | NCT05776030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Spinal Cord Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-07-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Over one million Americans rely on their upper extremities for manual wheelchair propulsion. Shoulder overuse injuries are prevalent among manual wheelchair users and these injuries often result in shoulder pain. Severe shoulder pain can lead some wheelchair users to transition from manual to powered mobility, complicating transportation, and reducing independence in activities of daily living. This project will expand the understanding of a new wheelchair design that allows better positioning of the hand rims and allows for different gearing. The investigators will study steady-state propulsion efficiency with different gear ratios and develop a new system with multiple gear ratios. The advanced gearing will allow for a low gear when initiating movement, going uphill, or when moving over carpet, and then a higher gear option for movements on hard flat level terrain. This system has the potential to dramatically improve shoulder ergonomics and reduce pain in many future manual wheelchair users.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: * Uses manual wheelchair daily * Mass less than 125 kg * Age 18 or older * Decisional competency to provide consent and cognitive ability to participate fully in study procedures * Body size appropriate to fit the wheelchairs (16" and 18" seat widths) Exclusion Criteria: Exclusion criteria: * Sitting surface pressure injuries * Flap procedure to address pressure injury less than one year earlier * Unable to obtain clinically acceptable seating system for study wheelchairs * Not able to propel a manual wheelchair * Upper extremity or spine issues which would make this study unsafe, such as recent surgeries, fractures, tendon tears or nerve impingement (will be assessed by SCI physician - Dr. Byron Eddy) * Medical conditions such as cardiovascular disease, pulmonary disease, or other conditions that would make the study procedures unsafe (will be assessed by SCI physician - Dr. Byron Eddy)
Contact & Investigator
John M Looft, PhD
PRINCIPAL INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Frequently Asked Questions
Who can join the NCT05776030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05776030 currently recruiting?
Yes, NCT05776030 is actively recruiting participants. Contact the research team at john.looft@va.gov for enrollment information.
Where is the NCT05776030 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05776030 clinical trial?
NCT05776030 is sponsored by VA Office of Research and Development. The principal investigator is John M Looft, PhD at Minneapolis VA Health Care System, Minneapolis, MN. The trial plans to enroll 30 participants.