Multi-Speed Ergonomic Wheelchair for Spinal Cord Injury

Overseen By Alexandria N Richardson, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Pressure injuries, Recent surgeries, Cardiovascular, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Multi-Speed Ergonomic Wheelchair treatment for spinal cord injury?

Research shows that wheelchair seat height and axle position can significantly affect wheeling efficiency and propulsion performance, which are important for spinal cord injury rehabilitation. Additionally, patients report high satisfaction with wheelchair fit and function, suggesting that well-designed wheelchairs can improve mobility and quality of life. ^{1 2 3 4 5}

Is the Multi-Speed Ergonomic Wheelchair generally safe for humans?

Evidence shows that injuries related to wheelchair use, including manual wheelchairs, are common and can be serious, with fractures being the most frequent. Safety concerns often involve engineering and environmental factors, and incidents like tips and falls are noted, especially in manual wheelchairs. ^{4 6 7 8 9}

How is the Multi-Speed Ergonomic Wheelchair treatment different from other treatments for spinal cord injury?

The Multi-Speed Ergonomic Wheelchair is unique because it offers adjustable gears, allowing users to change the speed and effort needed to propel the wheelchair, which can improve comfort and reduce energy expenditure compared to standard wheelchairs. This feature is particularly beneficial for individuals with spinal cord injuries, as it can help prevent overuse injuries in the shoulders and wrists. ^{2 5 7 10 11}

Research Team

John M Looft, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

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 am 18 years old or older.

I understand and can decide to participate in this study.

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

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

I can't get a suitable seat for the study's wheelchair.

Trial Timeline

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

Treatment Details

Interventions

• Multi-Speed Ergonomic Wheelchair (Device)
• Single Speed Ergonomic Wheelchair (Device)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Motor learning outcomes of handrim wheelchair propulsion during active spinal cord injury rehabilitation in comparison with experienced wheelchair users. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patterns in Wheeled Mobility Skills Training, Equipment Evaluation, and Utilization: Findings from the SCIRehab Project. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Wheelchair axle position effect on start-up propulsion performance of persons with tetraplegia. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Kinematics of wheelchair propulsion in adults and children with spinal cord injury. [2013]

5. Sweden pubmed.ncbi.nlm.nih.gov

Seat height: effects on submaximal hand rim wheelchair performance during spinal cord injury rehabilitation. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Wheelchair safety--adverse reports to the United States Food and Drug Administration. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Energy expenditure, and comfort in a modified wheelchair for people with hemiplegia: a controlled trial. [2019]

11. England pubmed.ncbi.nlm.nih.gov

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