Spinal Cord DiseasesNCT05776030
Multi-speed Ergonomic Wheelchair
A study testing Single Speed Ergonomic Wheelchair and Multi-Speed Ergonomic Wheelchair in people with Spinal Cord Diseases and Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Diseases, Spinal Cord Injuries
- What is being tested?
- Single Speed Ergonomic Wheelchair and Multi-Speed Ergonomic Wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Joshua P Nixon, PhD, 612-467-2804, Joshua.Nixon@va.gov
Julie Toth, RN, (612) 467-5655 ext. 5655, Julie.Toth@va.gov
About this study
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.
Read the detailed description
The Minneapolis Adaptive Design \& Engineering (MADE) Program has recently developed ergonomic wheelchairs that use a chain drive system to place the hand rims in an ergonomic position while keeping the rear drive wheels posterior for a stable base of support. The investigators' ergonomic wheelchair's forward hand rim positioning allows for a more efficient push along a longer arc length of the hand rims, without sacrificing wheelchair stability or shoulder ergonomics.
The ergonomic wheelchair's chain drive allows for individualized gear ratios to suit each wheelchair user's needs; however, the investigators have not yet studied this feature. Thus, the objectives of this proposed work are to (1) explore the effect of different gearing options on Veteran wheelchair user steady-state propulsion efficiency, and (2) develop a multi-speed ergonomic wheelchair allowing for lower gears during difficult situations (initiating movements, moving over carpeting) and higher gears for steady-state movements on flat surfaces.
The investigators will recruit 18 Veterans with SCI/D to participate in a cross-over study of the ergonomic wheelchair with three gear ratios (3:2 (low), 1:1 (normal), and 2:3 (high)). The investigators will use two measurement approaches to assess efficiency: (1) work done at the pushrim hubs to move the wheelchair in Joules (J), and (2) the measurement of energy (kCal: kilocalories) expended by the Veteran to move the wheelchair. Similar to miles per gallon in a car, the investigators will calculate distances traveled in meters (m) per energy units (m/J and m/kCal) as the measures of efficiency. The investigators hypothesize that (H1) Higher gear ratios will be more efficient (higher m/J) on hard level terrain than lower gear ratios, (H2) Lower gear ratios will be more efficient (higher m/J) for inclined terrain than higher gear ratios, (H3) Lower gear ratios will be more efficient (higher m/J) for carpeted terrain than higher gear ratios, and (H4) Veterans will be more efficient (higher m/kCal) in moving the wheelchair during the 6MPT on hard level terrain when using higher gear ratios compared with lower gear ratios. In addition to steady-state measures, the investigators will also explore the effects of gearing on propulsion initiation and expect lower gear ratios will be beneficial for initiation on all terrains.
The investigators will then recruit 12 Veterans to try a new multi-speed ergonomic wheelchair that has two hand rims per side - one in a lower gear and the other in a higher gear. The proposed system does not require manual or electric shifting between gears. Instead, the Veteran can use the lower gear to initiate movements and then "shift on the fly" by simply pushing on the other hand rim. Veterans will return to the laboratory and provide feedback as the design is iteratively improved. Quantitative and qualitative data will be captured to determine feasibility of this approach and to promote commercialization of the multi-speed ergonomic wheelchair.
Throughout the project, the team will work closely with VA's Technology Transfer Program and the TechLink Center to find an industry partner for this work. The investigators' team has demonstrated the ability to develop rehabilitation products into commercially licensed products. The investigators will follow a similar stage-gate process in this development project to maximize the chances for successful commercialization of the modular multi-speed ergonomic wheelchair.
- Conditions
- Spinal Cord Diseases, Spinal Cord Injuries
- Being tested
- Single Speed Ergonomic Wheelchair, Multi-Speed Ergonomic Wheelchair
- Keywords
- Wheelchairs, Community Participation, Social Participation, Ergonomics, Self-Help Devices
- Medical subject headings
- Spinal Cord Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Speed Ergonomic WheelchairDevice
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.
- 2:3
- 1:1
- 3:2
Multi-Speed Ergonomic WheelchairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: Multi-Speed Ergonomic Wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 Meter Push Test - level surface, Gear Ratio 1:1
Individuals self-propel a wheelchair 20 meters at their chosen pace
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 4 weeks after enrollment
QUEST 2.0 - Usual Wheelchair
The QUEST evaluates how satisfied one is with an assistive device.
Measured: up to 4 weeks after enrollment
QUEST 2.0 - Multispeed Wheelchair
The QUEST evaluates how satisfied one is with an assistive device.
Measured: up to 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start18 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John M Looft, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776030
- Sponsor's protocol ID
- A3664-R
- Other IDs
- 1 I02 RX003664-01P2
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-speed Ergonomic Wheelchair
- ClinicalTrials.gov ID
- NCT05776030
- Acronym / sponsor ID
- A3664-R
- Conditions
- Spinal Cord Diseases, Spinal Cord Injuries
- Keywords
- Wheelchairs, Community Participation, Social Participation, Ergonomics, Self-Help Devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Minneapolis Adaptive Design \& Engineering (MADE) Program has recently developed ergonomic wheelchairs that use a chain drive system to place the hand rims in an ergonomic position while keeping the rear drive wheels posterior for a stable base of support. The investigators' ergonomic wheelchair's forward hand rim positioning allows for a more efficient push along a longer arc length of the hand rims, without sacrificing wheelchair stability or shoulder ergonomics.
The ergonomic wheelchair's chain drive allows for individualized gear ratios to suit each wheelchair user's needs; however, the investigators have not yet studied this feature. Thus, the objectives of this proposed work are to (1) explore the effect of different gearing options on Veteran wheelchair user steady-state propulsion efficiency, and (2) develop a multi-speed ergonomic wheelchair allowing for lower gears during difficult situations (initiating movements, moving over carpeting) and higher gears for steady-state movements on flat surfaces.
The investigators will recruit 18 Veterans with SCI/D to participate in a cross-over study of the ergonomic wheelchair with three gear ratios (3:2 (low), 1:1 (normal), and 2:3 (high)). The investigators will use two measurement approaches to assess efficiency: (1) work done at the pushrim hubs to move the wheelchair in Joules (J), and (2) the measurement of energy (kCal: kilocalories) expended by the Veteran to move the wheelchair. Similar to miles per gallon in a car, the investigators will calculate distances traveled in meters (m) per energy units (m/J and m/kCal) as the measures of efficiency. The investigators hypothesize that (H1) Higher gear ratios will be more efficient (higher m/J) on hard level terrain than lower gear ratios, (H2) Lower gear ratios will be more efficient (higher m/J) for inclined terrain than higher gear ratios, (H3) Lower gear ratios will be more efficient (higher m/J) for carpeted terrain than higher gear ratios, and (H4) Veterans will be more efficient (higher m/kCal) in moving the wheelchair during the 6MPT on hard level terrain when using higher gear ratios compared with lower gear ratios. In addition to steady-state measures, the investigators will also explore the effects of gearing on propulsion initiation and expect lower gear ratios will be beneficial for initiation on all terrains.
The investigators will then recruit 12 Veterans to try a new multi-speed ergonomic wheelchair that has two hand rims per side - one in a lower gear and the other in a higher gear. The proposed system does not require manual or electric shifting between gears. Instead, the Veteran can use the lower gear to initiate movements and then "shift on the fly" by simply pushing on the other hand rim. Veterans will return to the laboratory and provide feedback as the design is iteratively improved. Quantitative and qualitative data will be captured to determine feasibility of this approach and to promote commercialization of the multi-speed ergonomic wheelchair.
Throughout the project, the team will work closely with VA's Technology Transfer Program and the TechLink Center to find an industry partner for this work. The investigators' team has demonstrated the ability to develop rehabilitation products into commercially licensed products. The investigators will follow a similar stage-gate process in this development project to maximize the chances for successful commercialization of the modular multi-speed ergonomic wheelchair.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Ergonomic Wheelchair Gear Testing | Experimental | Device: Single Speed Ergonomic WheelchairThis 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). |
| Multispeed Testing - Ergonomic Wheelchair | Experimental | Device: Multi-Speed Ergonomic WheelchairThe second aim will have participants compared to the participant's standard wheelchair to a multi-speed (2 gear ratios) ergonomic wheelchair. |
| Multispeed Testing - Standard Wheelchair | Experimental | Device: Multi-Speed Ergonomic WheelchairThe second aim will have participants compared to the participant's standard wheelchair to a multi-speed (2 gear ratios) ergonomic wheelchair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Speed Ergonomic WheelchairErgonomic 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 | Device | Ergonomic Wheelchair Gear Testing |
| Multi-Speed Ergonomic WheelchairThe 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. | Device | Multispeed Testing - Ergonomic Wheelchair, Multispeed Testing - Standard Wheelchair |
Primary outcome
20 Meter Push Test - level surface, Gear Ratio 1:1
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - level surface, Gear Ratio 2:3
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - level surface, Gear Ratio 3:2
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - uphill, Gear Ratio 1:1
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - uphill, Gear Ratio 2:3
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - uphill, Gear Ratio 3:2
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - Carpet, Gear Ratio 1:1
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - Carpet, Gear Ratio 2:3
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
20 Meter Push Test - Carpet, Gear Ratio 3:2
Time frame: up to 4 weeks after enrollment
Individuals self-propel a wheelchair 20 meters at their chosen pace
6 Minute Push Test - Usual Wheelchair, Temporal/Spatial
Time frame: up to 4 weeks after enrollment
Distance (m) and number of pushes will be collected during this test.
6 Minute Push Test - Gear Ratio 1:1, Temporal/Spatial
Time frame: up to 4 weeks after enrollment
Distance (m) and number of pushes will be collected during this test.
6 Minute Push Test - Gear Ratio 2:3, Temporal/Spatial
Time frame: up to 4 weeks after enrollment
Distance (m) and number of pushes will be collected during this test.
6 Minute Push Test - Gear Ratio 3:2, Temporal/Spatial
Time frame: up to 4 weeks after enrollment
Distance (m) and number of pushes will be collected during this test.
6 Minute Push Test - Usual Wheelchair, Metabolic (kCal/min)
Time frame: up to 4 weeks after enrollment
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
6 Minute Push Test - Gear Ratio 1:1, Metabolic (kCal/min)
Time frame: up to 4 weeks after enrollment
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
6 Minute Push Test - Gear Ratio 2:3, Metabolic (kCal/min)
Time frame: up to 4 weeks after enrollment
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
6 Minute Push Test - Gear Ratio 3:2, Metabolic (kCal/min)
Time frame: up to 4 weeks after enrollment
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
Wheelchair Skills Test Version 5.2 - Usual Wheelchair
Time frame: up to 4 weeks after enrollment
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.
Wheelchair Skills Test Version 5.2 - Multispeed Wheelchair
Time frame: up to 4 weeks after enrollment
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.
600 Meter Course - Usual Wheelchair, Timed (seconds)
Time frame: up to 4 weeks after enrollment
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).
600 Meter Course - Multispeed Wheelchair, Timed (seconds)
Time frame: up to 4 weeks after enrollment
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).
600 Meter Course - Usual Wheelchair, Rating of Perceived Exertion (RPE)
Time frame: up to 4 weeks after enrollment
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.
600 Meter Course - Multispeed Wheelchair, Rating of Perceived Exertion (RPE)
Time frame: up to 4 weeks after enrollment
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.
Mobility-Related ADL - Usual Wheelchair, Timed (seconds)
Time frame: up to 4 weeks after enrollment
This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine.
Mobility-Related ADL - Multispeed Wheelchair, Timed (seconds)
Time frame: up to 4 weeks after enrollment
This is a standardized, timed circuit of simulated mobility-related ADL tasks to simulate a morning ADL routine.
Mobility-Related ADL - Usual Wheelchair, Independency
Time frame: up to 4 weeks after enrollment
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).
Mobility-Related ADL - Multispeed Wheelchair, Independency
Time frame: up to 4 weeks after enrollment
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).
QUEST 2.0 - Usual Wheelchair
Time frame: up to 4 weeks after enrollment
The QUEST evaluates how satisfied one is with an assistive device.
QUEST 2.0 - Multispeed Wheelchair
Time frame: up to 4 weeks after enrollment
The QUEST evaluates how satisfied one is with an assistive device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John M Looft, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Speed Ergonomic Wheelchair and Multi-Speed Ergonomic Wheelchair in people with Spinal Cord Diseases and Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Looft, PhD ((612) 725-2001, john.looft@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 Meter Push Test - level surface, Gear Ratio 1:1 (time frame: up to 4 weeks after enrollment). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.