Multi-speed Ergonomic Wheelchair

NCT05776030 | Recruiting FDA Device

• 2 other identifiers: A3664-R1 I02 RX003664-01P2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (29)

• 20 Meter Push Test - level surface, Gear Ratio 1:1

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - level surface, Gear Ratio 2:3

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - level surface, Gear Ratio 3:2

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - uphill, Gear Ratio 1:1

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - uphill, Gear Ratio 2:3

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - uphill, Gear Ratio 3:2

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - Carpet, Gear Ratio 1:1

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - Carpet, Gear Ratio 2:3

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 20 Meter Push Test - Carpet, Gear Ratio 3:2

  Individuals self-propel a wheelchair 20 meters at their chosen pace

  up to 4 weeks after enrollment

• 6 Minute Push Test - Usual Wheelchair, Temporal/Spatial

  Distance (m) and number of pushes will be collected during this test.

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 1:1, Temporal/Spatial

  Distance (m) and number of pushes will be collected during this test.

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 2:3, Temporal/Spatial

  Distance (m) and number of pushes will be collected during this test.

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 3:2, Temporal/Spatial

  Distance (m) and number of pushes will be collected during this test.

  up to 4 weeks after enrollment

• 6 Minute Push Test - Usual Wheelchair, Metabolic (kCal/min)

  Oxygen Uptake (VO2: L/min), Carbon dioxide production (VCO2: L/min), and respiratory quotient (RQ) will all be collected using a COSMED K5 portable metabolic measurement system These measures are used for calculating kCal/min = (\[1.1 \* RQ\] + 3.9) \* VO2

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 1:1, Metabolic (kCal/min)

  Oxygen Uptake (VO2: L/min), Carbon dioxide production (VCO2: L/min), and respiratory quotient (RQ) will all be collected using a COSMED K5 portable metabolic measurement system These measures are used for calculating kCal/min = (\[1.1 \* RQ\] + 3.9) \* VO2

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 2:3, Metabolic (kCal/min)

  Oxygen Uptake (VO2: L/min), Carbon dioxide production (VCO2: L/min), and respiratory quotient (RQ) will all be collected using a COSMED K5 portable metabolic measurement system These measures are used for calculating kCal/min = (\[1.1 \* RQ\] + 3.9) \* VO2

  up to 4 weeks after enrollment

• 6 Minute Push Test - Gear Ratio 3:2, Metabolic (kCal/min)

  Oxygen Uptake (VO2: L/min), Carbon dioxide production (VCO2: L/min), and respiratory quotient (RQ) will all be collected using a COSMED K5 portable metabolic measurement system These measures are used for calculating kCal/min = (\[1.1 \* RQ\] + 3.9) \* VO2

  up to 4 weeks after enrollment

• Wheelchair Skills Test Version 5.2 - Usual Wheelchair

  The WST is used for objective evaluation of manual wheelchair skills. It includes 32 skills that are rates advanced pass/highly proficient (3 points), pass (2 points), pass with difficulty (1 point), or fail (0 points). The WST covers a wide variety of skills that manual wheelchair users experience in everyday life including inclines, side slopes, soft surface, thresholds, gaps, curbs, obstacle avoidance, and wheelies.

  up to 4 weeks after enrollment

• Wheelchair Skills Test Version 5.2 - Multispeed Wheelchair

  The WST is used for objective evaluation of manual wheelchair skills. It includes 32 skills that are rates advanced pass/highly proficient (3 points), pass (2 points), pass with difficulty (1 point), or fail (0 points). The WST covers a wide variety of skills that manual wheelchair users experience in everyday life including inclines, side slopes, soft surface, thresholds, gaps, curbs, obstacle avoidance, and wheelies.

  up to 4 weeks after enrollment

• 600 Meter Course - Usual Wheelchair, Timed (seconds)

  The distance of 600 meters is used clinically to assess community ambulation ability and can be used to determine if a power wheelchair is needed. The 600 meter course will include several turns, carpeting, and starting/stopping the wheelchair. Participants will be instructed to complete the course at a comfortable pace and will be timed (s).

  up to 4 weeks after enrollment

• 600 Meter Course - Multispeed Wheelchair, Timed (seconds)

  The distance of 600 meters is used clinically to assess community ambulation ability and can be used to determine if a power wheelchair is needed. The 600 meter course will include several turns, carpeting, and starting/stopping the wheelchair. Participants will be instructed to complete the course at a comfortable pace and will be timed (s).

  up to 4 weeks after enrollment

• 600 Meter Course - Usual Wheelchair, Rating of Perceived Exertion (RPE)

  The distance of 600 meters is used clinically to assess community ambulation ability and can be used to determine if a power wheelchair is needed. The 600 meter course will include several turns, carpeting, and starting/stopping the wheelchair. Participants will be instructed to complete the course at a comfortable pace and RPE will be asked at the end of the course.

  up to 4 weeks after enrollment

• 600 Meter Course - Multispeed Wheelchair, Rating of Perceived Exertion (RPE)

  The distance of 600 meters is used clinically to assess community ambulation ability and can be used to determine if a power wheelchair is needed. The 600 meter course will include several turns, carpeting, and starting/stopping the wheelchair. Participants will be instructed to complete the course at a comfortable pace and RPE will be asked at the end of the course.

  up to 4 weeks after enrollment

• Mobility-Related ADL - Usual Wheelchair, Timed (seconds)

  This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine.

  up to 4 weeks after enrollment

• Mobility-Related ADL - Multispeed Wheelchair, Timed (seconds)

  This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine.

  up to 4 weeks after enrollment

• Mobility-Related ADL - Usual Wheelchair, Independency

  This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine. All ICF activity-based measures of function in a wheelchair. Independence for tasks will be scored using the Function Everyday with a Wheelchair Capacity scoring from 0 (dependent) to 3 (independent).

  up to 4 weeks after enrollment

• Mobility-Related ADL - Multispeed Wheelchair, Independency

  This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine. All ICF activity-based measures of function in a wheelchair. Independence for tasks will be scored using the Function Everyday with a Wheelchair Capacity scoring from 0 (dependent) to 3 (independent).

  up to 4 weeks after enrollment

• QUEST 2.0 - Usual Wheelchair

  The QUEST evaluates how satisfied one is with an assistive device.

  up to 4 weeks after enrollment

• QUEST 2.0 - Multispeed Wheelchair

  The QUEST evaluates how satisfied one is with an assistive device.

  up to 4 weeks after enrollment

Study Arms (3)

Ergonomic Wheelchair Gear Testing

EXPERIMENTAL

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).

Device: Single Speed Ergonomic Wheelchair

Multispeed Testing - Ergonomic Wheelchair

EXPERIMENTAL

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

Device: Multi-Speed Ergonomic Wheelchair

Multispeed Testing - Standard Wheelchair

EXPERIMENTAL

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

Device: Multi-Speed Ergonomic Wheelchair

Interventions

Single Speed Ergonomic Wheelchair DEVICE

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

Ergonomic Wheelchair Gear Testing

Multi-Speed Ergonomic Wheelchair DEVICE

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.

Multispeed Testing - Ergonomic Wheelchair; Multispeed Testing - Standard Wheelchair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• John M Looft, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Looft, PhD

CONTACT

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

Alexandria N Richardson, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: H1) Single group assignment with crossover design where participant will be randomized which of 3 gear ratios they start with and then which is second, than the last one. n=18 H2) Two Groups for randomized assignment of which chair (geared or not) the participant starts with and then crosses over to second chair. n=12

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: July 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)