Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05776030

Conditions

Spinal Cord Diseases

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single Speed Ergonomic Wheelchair

Multi-Speed Ergonomic Wheelchair

Study Details

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.

Conditions

Spinal Cord Diseases

Spinal Cord Injuries

Study ID

NCT05776030

Start date

Jul 18, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ergonomic Wheelchair Gear Testing

This study has two aims. The first aim will have participants use a single speed ergonomic wheelchair to test three different gear ratio set ups (3:2, 1:1, 2:3).

experimental: Multispeed Testing - Ergonomic Wheelchair

The second aim will have participants compared to the participant's standard wheelchair to a multi-speed (2 gear ratios) ergonomic wheelchair.

experimental: Multispeed Testing - Standard Wheelchair

The second aim will have participants compared to the participant's standard wheelchair to a multi-speed (2 gear ratios) ergonomic wheelchair.

Interventions

Single Speed Ergonomic Wheelchair

Ergonomic wheelchair. The ergonomic wheelchair was developed by the MADE program and has anterior placed hand rims that are connected with a bicycle chain. In Aim 1, Participants will use the ergonomic wheelchair to test 3 different gear ratios.

1. 2:3
2. 1:1
3. 3:2

Multi-Speed Ergonomic Wheelchair

The multi-speed ergonomic wheelchair will be developed by the MADE program and will use a two-hand rim design so the participant can change gears by changing hand rims.

Primary outcome measure

  • 20 Meter Push Test - level surface, Gear Ratio 1:1 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - level surface, Gear Ratio 2:3 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - level surface, Gear Ratio 3:2 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - uphill, Gear Ratio 1:1 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - uphill, Gear Ratio 2:3 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - uphill, Gear Ratio 3:2 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - Carpet, Gear Ratio 1:1 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - Carpet, Gear Ratio 2:3 [ Time Frame: up to 4 weeks after enrollment ]
  • 20 Meter Push Test - Carpet, Gear Ratio 3:2 [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Usual Wheelchair, Temporal/Spatial [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 1:1, Temporal/Spatial [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 2:3, Temporal/Spatial [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 3:2, Temporal/Spatial [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Usual Wheelchair, Metabolic (kCal/min) [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 1:1, Metabolic (kCal/min) [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 2:3, Metabolic (kCal/min) [ Time Frame: up to 4 weeks after enrollment ]
  • 6 Minute Push Test - Gear Ratio 3:2, Metabolic (kCal/min) [ Time Frame: up to 4 weeks after enrollment ]
  • Wheelchair Skills Test Version 5.2 - Usual Wheelchair [ Time Frame: up to 4 weeks after enrollment ]
  • Wheelchair Skills Test Version 5.2 - Multispeed Wheelchair [ Time Frame: up to 4 weeks after enrollment ]
  • 600 Meter Course - Usual Wheelchair, Timed (seconds) [ Time Frame: up to 4 weeks after enrollment ]
  • 600 Meter Course - Multispeed Wheelchair, Timed (seconds) [ Time Frame: up to 4 weeks after enrollment ]
  • 600 Meter Course - Usual Wheelchair, Rating of Perceived Exertion (RPE) [ Time Frame: up to 4 weeks after enrollment ]
  • 600 Meter Course - Multispeed Wheelchair, Rating of Perceived Exertion (RPE) [ Time Frame: up to 4 weeks after enrollment ]
  • Mobility-Related ADL - Usual Wheelchair, Timed (seconds) [ Time Frame: up to 4 weeks after enrollment ]
  • Mobility-Related ADL - Multispeed Wheelchair, Timed (seconds) [ Time Frame: up to 4 weeks after enrollment ]
  • Mobility-Related ADL - Usual Wheelchair, Independency [ Time Frame: up to 4 weeks after enrollment ]
  • Mobility-Related ADL - Multispeed Wheelchair, Independency [ Time Frame: up to 4 weeks after enrollment ]
  • QUEST 2.0 - Usual Wheelchair [ Time Frame: up to 4 weeks after enrollment ]
  • QUEST 2.0 - Multispeed Wheelchair [ Time Frame: up to 4 weeks after enrollment ]

Central Contacts and Locations

Central contacts

John M Looft, PhD

(612) 725-2001john.looft@va.gov

Alexandria N Richardson, MS

(612) 467-4951Alexandria.Richardson@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Joshua P Nixon, PhD

612-467-2804Joshua.Nixon@va.gov

Julie Toth, RN

(612) 467-5655Julie.Toth@va.gov

Principal Investigator:

John M Looft, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Wheelchairs
  • Community Participation
  • Social Participation
  • Ergonomics
  • Self-Help Devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-20.