Manual Standing Wheelchair for Spinal Cord Injury

(MMSW-SCI Trial)

Recruiting at 1 trial location

Overseen By Alexandria N Richardson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Uncontrolled hypertension, Uncontrolled spasticity, Low BMD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

People with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are not able to stand without support. Excessive sitting after SCI is believed to contribute to pressure injuries, pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. The VA has developed, patented, and licensed a mobile manual standing wheelchair (MMSW), and the investigators believe the key feature of being able to wheel around while in a standing position will dramatically change how paralyzed Veterans function in their home and community. If this expanded utility is realized, persons with SCI may naturally spend more time standing and less time sitting. To test these ideas, Veterans with SCI will be randomized to using one of two manual standing wheelchairs at home and in the community for two months.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Manual Standing Wheelchair for Spinal Cord Injury?

Research shows that using standing mobility devices, like the Manual Standing Wheelchair, can improve quality of life, reduce bed sores, and enhance bladder and bowel function for people with spinal cord injuries. Additionally, users of a prototype standing wheelchair reported that being able to move while standing was very important for their health and function. ^{1 2 3 4 5}

Is the Manual Standing Wheelchair safe for humans?

The Manual Standing Wheelchair has been tested for stability, and users have reported feeling stable and mobile while using it. However, general wheelchair safety data shows that injuries can occur, with fractures being the most common, so it's important to use the wheelchair as directed and be aware of potential risks. ^{1 4 5 6 7}

How does the Manual Standing Wheelchair treatment differ from other treatments for spinal cord injury?

The Manual Standing Wheelchair is unique because it allows users to be mobile while standing, unlike other manual wheelchairs that are only mobile when seated. This added mobility in the standing position can improve health and function for users, making it a novel option for those with spinal cord injuries. ^{1 4 5 8 9}

Research Team

Andrew H Hansen, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

B. Jenny Kiratli, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

This trial is for Veterans with spinal cord injuries who use a manual wheelchair, weigh less than 275 lbs, have decision-making capacity, and fit the device size. They must be at least 6 months post-injury and not in another mobility study. Exclusions include low bone density, unhealed fractures or pressure injuries, recent flap surgery, inability to operate the chair or stand mechanism.

Inclusion Criteria

I am a veteran with a spinal cord injury between my neck and mid-back.

It has been over 6 months since my injury.

I am mentally capable of understanding and agreeing to the study's requirements.

Exclusion Criteria

My bone density is significantly lower than normal.

My lower-limb joints are unstable.

I cannot stand due to issues like tight muscles or very high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-6 months

Treatment

Participants use a manual standing wheelchair at home and in the community

8 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Manual Standing Wheelchair
• Mobile Manual Standing Wheelchair

Trial Overview The study compares two types of wheelchairs: a newly developed mobile manual standing wheelchair (MMSW) that allows users to move while standing against a standard manual standing wheelchair. Participants will randomly receive one type to use for two months at home and in their community.

Participant Groups

Group I: Mobile Manual Standing Wheelchair Experimental Treatment 1 Intervention

Mobile in BOTH seated and standing positions

Group II: Manual Standing Wheelchair Active Control 1 Intervention

Mobile in seated position; Not mobile in standing position

Manual Standing Wheelchair is already approved in United States for the following indications:

Approved in United States as Manual Standing Wheelchair for:

• Spinal Cord Injuries
• Pressure Injuries
• Pain Management
• Osteoporosis Prevention
• Joint Stiffness Management
• Spasticity Management
• Bowel and Bladder Function Improvement

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The mobile manual standing wheelchair (MMSW) successfully met safety standards and allowed users to achieve mobility speeds in both seated (1.11 m/s) and standing (0.79 m/s) positions that are comparable to typical home environments.

Participants reported that the MMSW could significantly enhance their quality of life, with one user achieving standing speeds similar to average walking speeds, suggesting potential health benefits from increased standing time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design refinement and evaluation of a mobile manual standing wheelchair. Goldish, G., Voss, G., Morin, S., et al.[2023]

In a survey of 99 individuals with spinal cord injury, those who used standing mobility devices for 30 minutes or more daily reported significant improvements in quality of life, fewer bed sores, and fewer bladder infections compared to those who stood less.

High compliance rates (74%) for regular home standing suggest that standing mobility devices could be a valuable intervention for improving health outcomes and quality of life, even for individuals who begin using them years after their injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for a home standing program for individuals with spinal cord injury. Walter, JS., Sola, PG., Sacks, J., et al.[2022]

The inclusion of three additional items in the Adapted Manual Wheelchair Circuit (AMWC+3) significantly improved its ability to differentiate between individuals with high, medium, and low paraplegia, as shown by a statistical analysis of 126 participants.

The AMWC+3 demonstrated better sensitivity in assessing performance, with the low paraplegia group showing significantly better scores and faster completion times compared to the high and medium paraplegia groups, indicating that the modifications enhance the assessment of wheelchair mobility capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The addition of three new items in the Adapted Manual Wheelchair Circuit improves the discrimination between different levels of spinal cord injury. Ribeiro Neto, F., Costa, RRG., Carregaro, RL.[2021]

A prototype of a manual standing wheelchair with a chain drive system was developed, allowing users to move while standing, which could enhance health and functionality for users with spinal cord injuries.

Feedback from four veterans indicated that the ability to move while standing was crucial for them, and they appreciated the stability of the design, suggesting that further refinements like reducing width and weight could improve usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drive system to add standing mobility to a manual standing wheelchair. Nickel, E., Hansen, A., Pearlman, J., et al.[2019]

Recent advancements in powered wheelchairs, particularly those that allow for passive standing, have shown significant health benefits for users, including reduced seating pressure and improved circulation, as supported by scientific studies.

Legislation is being developed to ensure that wheeled mobility suppliers are certified and educated, which is crucial for increasing access to these beneficial technologies for physically immobile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological advances in powered wheelchairs. Edlich, RF., Nelson, KP., Foley, ML., et al.[2019]

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 30 participants with spinal cord injuries, 93.3% reported feeling happy when using the Arise Standing Wheelchair (SWC), indicating a positive user experience with its standing functionality.

The majority (83.3%) preferred the Arise SWC over their current wheelchair, suggesting that its design and features could enhance mobility and quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User experience study of an affordable manual standing wheelchair. Daniel, S., Rawat, N., Iyer, R., et al.[2023]

The document outlines typical clinical applications for wheelchair standers, highlighting their importance in rehabilitation and assistive technology.

It provides evidence from the literature that supports the effectiveness of wheelchair standers in improving mobility and quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RESNA position on the application of wheelchair standing devices. Arva, J., Paleg, G., Lange, M., et al.[2009]

A case study demonstrated the effectiveness of an electrically powered mobile stand-up device for a patient with a complete spinal cord lesion at cervical level C7, allowing them to perform both sitting and standing tasks in a flower nursery.

This device serves as a practical aid to help individuals with severe spinal cord injuries reintegrate into their work environments, highlighting its potential for improving quality of life and occupational engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. van den Berg, JP., den Ouden, A., Stam, HJ.[2004]

References

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

Design refinement and evaluation of a mobile manual standing wheelchair. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Indications for a home standing program for individuals with spinal cord injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The addition of three new items in the Adapted Manual Wheelchair Circuit improves the discrimination between different levels of spinal cord injury. [2021]

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

A drive system to add standing mobility to a manual standing wheelchair. [2019]

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

Technological advances in powered wheelchairs. [2019]

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

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

7. England pubmed.ncbi.nlm.nih.gov

User experience study of an affordable manual standing wheelchair. [2023]

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

RESNA position on the application of wheelchair standing devices. [2009]

9. England pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. [2004]