Manual Standing Wheelchair for Spinal Cord Injury

(MMSW-SCI Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new type of wheelchair can assist people with spinal cord injuries (SCI) by enabling movement while standing. It tests two kinds of wheelchairs: one that moves while seated and another, the Manual Standing Wheelchair, that allows movement both seated and standing. Researchers hope that spending more time standing can reduce issues like pain, stiffness, and pressure sores. Veterans who have had an SCI for more than six months, need support to stand, and regularly use a manual wheelchair might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility and quality of life for individuals with SCI.

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 prior data suggests that this manual standing wheelchair is safe for people with spinal cord injuries?

Research has shown that the Mobile Manual Standing Wheelchair (MMSW) is generally safe. Users report feeling stable and able to move around while using it. In one study, participants rated their feeling of safety as 8.4 out of 10, indicating a strong sense of security. The MMSW also allows users to stand and move, which can help prevent health issues from prolonged sitting, such as pressure sores and stiff joints.

The Manual Standing Wheelchair, although stationary when standing, has also been tested for stability, with users reporting a stable experience. This suggests that both types of wheelchairs in the study are well-received by users. Overall, the safety results are positive, but it's crucial to consider individual health needs before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Manual Standing Wheelchair and the Mobile Manual Standing Wheelchair because they offer new mobility options for individuals with spinal cord injuries. Unlike traditional wheelchairs that are primarily functional in a seated position, the Mobile Manual Standing Wheelchair is designed to be mobile in both seated and standing positions. This feature could significantly enhance independence and improve quality of life by allowing users to easily switch between sitting and standing, which is not possible with standard wheelchairs. These innovations aim to provide greater flexibility and functionality, potentially transforming daily activities and interactions for users.

What evidence suggests that the Mobile Manual Standing Wheelchair is effective for spinal cord injury?

Research has shown that standing wheelchairs can greatly benefit people with spinal cord injuries (SCI). In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of two types of standing wheelchairs. The Manual Standing Wheelchair, mobile in a seated position but not in a standing position, has helped users feel more stable and able to move around. Meanwhile, the Mobile Manual Standing Wheelchair, mobile in both seated and standing positions, has made users feel safe and comfortable when standing. This type of wheelchair also improves movement and reduces pressure sores from prolonged sitting. Early findings suggest that the ability to move while standing can lead to more time spent standing, which might alleviate joint stiffness and improve blood flow. Overall, standing wheelchairs appear to be a promising option for enhancing the quality of life for people with SCI. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. resna.org resna.org/sites/default/files/conference/2015/wheeled_mobility/nickel.html

A Drive system to add standing mobility to a manual ... A prototype manual standing wheelchair with standing mobility was developed with feedback from a User Advisory Panel of four wheelchair users.

2. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1504840/full

A randomized comparative effectiveness trial to evaluate ... A WODAA approach to PA is comparable or more effective than a traditional PACE program in promoting physical activity in low-active manual wheelchair users ...

3. withpower.com withpower.com/trial/phase-spinal-cord-injuries-2022-8f72a

Manual Standing Wheelchair for Spinal Cord Injury (MMSW-SCI ... The Manual Standing Wheelchair has been tested for stability, and users have reported feeling stable and mobile while using it. However, general wheelchair ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3151726/

Monitoring standing wheelchair use after spinal cord injury This case report describes a method to monitor dose of standing outside the laboratory, describes the standing patterns of one subject, and describes this ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04668326/mobile-manual-standing-wheelchair-for-sci

Mobile Manual Standing Wheelchair for SCI SCI or stable disorder/dysfunction of the spinal cord. Tolerates manual wheelchair use on a regular basis. Sufficient hand & arm function to ...

6. tandfonline.com tandfonline.com/doi/abs/10.1080/17483107.2022.2041737

Design refinement and evaluation of a mobile manual ... Increased standing time may lead to several health benefits for manual wheelchair users. Keywords: Accessibility · spinal cord injury · manual · wheelchair ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.03.05.25323410v1.full.pdf

Feasibility, Usability, and Acceptability of a Novel Open- ... Our questionnaire data suggest that the study participants felt safe (8.4/10) in our standing wheelchair and all subjects showed a lower level ...