Multi-Speed Ergonomic Wheelchair for Spinal Cord Injury

Overseen By Alexandria N Richardson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pressure injuries, Recent surgeries, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new multi-speed ergonomic wheelchair can reduce shoulder pain for daily manual wheelchair users. Researchers will test whether different gear options ease pushing, particularly when starting to move, going uphill, or on challenging surfaces like carpet. The goal is to enhance comfort and independence by reducing the need to switch to a powered wheelchair. The trial seeks participants who use a manual wheelchair daily and can safely operate various wheelchair types. As an unphased trial, this study offers participants the chance to contribute to innovative solutions that improve daily life for manual wheelchair users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this wheelchair design is safe for users?

Research shows that the multi-speed ergonomic wheelchair aims to improve shoulder comfort and reduce pain for manual wheelchair users. Although specific safety information for this wheelchair is limited, the study is labeled as "Not Applicable" for phases, indicating it might not have undergone the same safety testing as other studies. However, the wheelchair's design to reduce shoulder strain suggests it may be comfortable to use.

For those considering participation, the wheelchair's goal is to provide better support and comfort. Its advanced gears could help prevent shoulder injuries, which are common among manual wheelchair users. While no specific side effects are mentioned, the focus on comfort and safety is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a multi-speed ergonomic wheelchair could enhance mobility for people with spinal cord injuries. Unlike traditional wheelchairs, which typically have a single speed, this innovative wheelchair offers multiple gear ratios, allowing users to adjust their speed and effort depending on the terrain. This could lead to increased efficiency and comfort, making daily activities easier and less tiring. By comparing these advanced wheelchairs to standard ones, researchers hope to discover if these new features significantly improve the quality of life for users.

What evidence suggests that this wheelchair design is effective for reducing shoulder pain in spinal cord injury patients?

This trial will compare different wheelchair designs to assess their impact on ease of use and shoulder strain. Participants in one arm will test a single-speed ergonomic wheelchair with three gear ratio setups (3:2, 1:1, 2:3). Another arm will involve testing a multi-speed ergonomic wheelchair with two gear ratios. Research has shown that geared wheelchair wheels can ease manual wheelchair movement, reducing shoulder strain and potentially decreasing the risk of shoulder pain for users. Early results suggest that different gear options are especially useful when starting to move, going uphill, or rolling over surfaces like carpet. This could make daily wheelchair use easier and more comfortable. The design aims to improve shoulder comfort, which might help users remain independent longer by delaying the need to switch to powered wheelchairs. ^{1 2 3 6 7}

Who Is on the Research Team?

John M Looft, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for individuals over 18 who use a manual wheelchair daily, weigh less than 125 kg, and can fit into wheelchairs with seat widths of 16" or 18". Participants must be able to make decisions and follow study procedures. Those with recent surgeries, pressure injuries, cardiovascular or pulmonary diseases that could affect safety are excluded.

Inclusion Criteria

I understand and can decide to participate in this study.

I can fit into a wheelchair with a seat width of 16" or 18".

I use a manual wheelchair every day.

Exclusion Criteria

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)

Sitting surface pressure injuries

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a single speed ergonomic wheelchair to test three different gear ratio setups (3:2, 1:1, 2:3) and a multi-speed ergonomic wheelchair with two gear ratios.

4 weeks

Multiple visits for testing and feedback

Follow-up

Participants are monitored for safety and effectiveness after treatment, including feedback on the wheelchair design.

4 weeks

Extension

Participants may continue to use the multi-speed ergonomic wheelchair for further testing and feedback.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Speed Ergonomic Wheelchair
• Single Speed Ergonomic Wheelchair

Trial Overview The study compares two types of ergonomic wheelchairs: one with multiple gear options versus a single-speed version. It aims to see if the multi-gear design improves hand rim positioning and reduces shoulder pain by offering easier movement initiation and adaptability to different terrains.

How Is the Trial Designed?

Group I: Multispeed Testing - Standard Wheelchair Experimental Treatment 1 Intervention

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

Group II: Multispeed Testing - Ergonomic Wheelchair Experimental Treatment 1 Intervention

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

Group III: Ergonomic Wheelchair Gear Testing Experimental Treatment 1 Intervention

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).

Multi-Speed Ergonomic Wheelchair is already approved in United States, European Union for the following indications:

Approved in United States as Multi-Speed Ergonomic Wheelchair for:

• Mobility assistance for individuals with physical disabilities

Approved in European Union as Multi-Speed Ergonomic Wheelchair for:

• Mobility assistance for individuals with physical disabilities

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The ergonomic self-propelled steering (ESP) mechanism significantly reduced heart rate, oxygen consumption, and carbon dioxide output in non-disabled subjects, indicating improved energy efficiency while using the modified wheelchair.

Participants reported greater comfort levels when using the ESP-modified wheelchair compared to the standard model, suggesting that the modification enhances the overall user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy expenditure, and comfort in a modified wheelchair for people with hemiplegia: a controlled trial. Mandy, A., Lesley, S., Lucas, K.[2019]

The modified wheelchair with the ergonomic self-propelled steering (ESP) kit significantly reduced oxygen consumption and carbon dioxide output, indicating improved ergonomic efficiency for hemiplegic users during propulsion.

Participants using the ESP wheelchair completed the course faster and reported greater comfort compared to the standard wheelchair, highlighting the benefits of the ESP kit for enhancing user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures of energy expenditure and comfort in an ESP wheelchair: a controlled trial using hemiplegic users'. Mandy, A., Lesley, S.[2015]

Most patients with traumatic spinal cord injury participated in wheelchair skills training during rehabilitation, with a focus on propulsion and driving skills, indicating a structured approach to enhancing mobility.

Patients reported high satisfaction with their wheelchairs' fit and function one year post-injury, suggesting that clinicians are effectively prescribing and fitting mobility devices based on individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in Wheeled Mobility Skills Training, Equipment Evaluation, and Utilization: Findings from the SCIRehab Project. Taylor, S., Gassaway, J., Heisler-Varriale, LA., et al.[2015]

In a pilot study involving 14 spinal cord injured manual wheelchair users, the SmartDrive assistive device showed a tendency to reduce shoulder pain and significantly increased satisfaction in mobility activities over six months.

Participants reported improved independence and the ability to navigate slopes they previously could not manage, highlighting the SmartDrive's potential as a valuable tool for enhancing mobility despite shoulder pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the SmartDrive on mobility, activity, and shoulder pain among manual wheelchair users with spinal cord injury - a prospective long-term cohort pilot study. Butler Forslund, E., Löfvenmark, I.[2022]

In a study involving 12 individuals with spinal cord injuries, optimal wheelchair seat heights for improving wheeling efficiency were found to be between 100-130 degrees elbow angle, which reduced physical strain during rehabilitation.

Lower seat heights negatively impacted mechanical efficiency and required greater forces on the hand rims, suggesting that adjusting seat height can enhance manual wheeling performance and comfort for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seat height: effects on submaximal hand rim wheelchair performance during spinal cord injury rehabilitation. van der Woude, LH., Bouw, A., van Wegen, J., et al.[2014]

In a study of 2,213 full-time wheelchair users with spinal cord injuries, nearly 45% experienced wheelchair repairs within six months, and 8.7% faced adverse consequences from breakdowns, highlighting a significant issue for this population.

Power wheelchair users had a notably higher frequency of repairs and adverse consequences compared to manual wheelchair users, indicating that the type of wheelchair may influence reliability and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. McClure, LA., Boninger, ML., Oyster, ML., et al.[2015]

This study found that children with spinal cord injuries propel their wheelchairs in a manner similar to adults, despite differences in size and age, suggesting that techniques used in adult wheelchair propulsion can be applied to pediatric users.

Both adult and pediatric groups spent the same proportion of their wheeling cycle in propulsion (24%), indicating that the fundamental mechanics of wheelchair propulsion are consistent across age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematics of wheelchair propulsion in adults and children with spinal cord injury. Bednarczyk, JH., Sanderson, DJ.[2013]

A study analyzing 651 FDA records from 1975 to 1993 found that wheelchair-related injuries are common, with 368 injuries reported, including 21 fatalities, primarily involving fractures (45.5%).

The majority of incidents were linked to engineering factors (60.5%), highlighting the need for improved design and safety measures in wheelchairs and scooters to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair safety--adverse reports to the United States Food and Drug Administration. Kirby, RL., Ackroyd-Stolarz, SA.[2019]

In a study involving eight individuals with chronic C6 tetraplegia, the up and forward axle position of the wheelchair significantly increased speed and acceleration during propulsion, making it the most effective configuration for wheelchair use.

Conversely, the down and backward axle position resulted in the lowest speed and acceleration, highlighting the importance of axle positioning in optimizing wheelchair performance and reducing shoulder strain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair axle position effect on start-up propulsion performance of persons with tetraplegia. Freixes, O., Fernández, SA., Gatti, MA., et al.[2013]

Selecting a wheelchair and seating system for individuals with spinal cord injuries requires a comprehensive model that considers personal needs, wheelchair design, and various environmental factors, emphasizing the importance of individualized care.

The review highlights biomechanical differences in seated posture between individuals with and without spinal cord injuries, addressing the risk of overuse injuries in the shoulders and wrists, and the necessity for further research to improve clinical practices and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seating and mobility considerations for people with spinal cord injury. Minkel, JL.[2013]

During the first five weeks of rehabilitation for individuals with recent spinal cord injuries, there were no significant improvements in mechanical efficiency or propulsion technique, despite improvements in peak power output and performance on a wheelchair circuit.

The study found that experienced wheelchair users had higher mechanical efficiency compared to those with recent injuries, suggesting that important adaptations in wheelchair propulsion may occur earlier in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor learning outcomes of handrim wheelchair propulsion during active spinal cord injury rehabilitation in comparison with experienced wheelchair users. Leving, MT., de Groot, S., Woldring, FAB., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05776030

NCT05776030 | Multi-speed Ergonomic Wheelchair 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 ...

2. withpower.com withpower.com/trial/phase-spinal-cord-injuries-6-2023-714a3

Multi-Speed Ergonomic Wheelchair for Spinal Cord Injury What data supports the effectiveness of the Multi-Speed Ergonomic Wheelchair treatment for spinal cord injury? Research shows that wheelchair seat height ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950945/

Use of an upright power wheelchair in spinal cord injury In this small case series of chronic, non-ambulatory individuals with SCI, the standing powered wheelchair was shown to be safe and efficacious.

4. mdpi.com mdpi.com/2673-7078/5/4/80

The Effects of Using Geared Wheels on Energy ... Objectives: To quantify the effects of geared wheelchair wheels on energy expenditure during manual wheelchair propulsion in individuals with spinal cord ...

5. scireproject.com scireproject.com/wp-content/uploads/2022/01/wheeled-mobility_V7.pdf

Wheeled Mobility and Seating Equipment Following Spinal ... 1.0 Executive Summary. Wheelchairs and seating are one of the most important and most frequently used assistive technologies for people who have a spinal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12072826/

Systematic Review of Usability Tests for Manual Wheelchairs Background: Manual wheelchairs (MWCs) are critical assistive devices for individuals with spinal cord injury (SCI) and other mobility ...

7. mdpi.com mdpi.com/2076-3417/14/23/11087

Variation in Daily Wheelchair Mobility Metrics of Persons ... Manual wheelchair users (MWUs) frequently report shoulder problems and have a three-times-higher likelihood of rotator cuff pathology compared to ...