Modular Pressure Relief Cushions for Mobility Impairment

(Squishycushion Trial)

Overseen By Kath M Bogie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Inability to remain seated

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of modular cushions designed to assist wheelchair users with mobility impairments. The goal is to determine if these cushions can improve comfort, skin health, and daily function while remaining cost-effective. Participants will use each cushion type, the Gel Ball Fitted Modular Cushion and the Squishins Fitted Modular Cushion, for two weeks. Veterans who use wheelchairs full-time and can remain seated for more than four hours a day are ideal candidates for this trial. As an unphased trial, participants can contribute to innovative research that may enhance daily life for 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.

What prior data suggests that these modular cushions are safe for wheelchair users?

Research has not provided specific safety information for the GEL BALL and SQUISHINS FITTED MODULAR CUSHIONS. However, past studies have emphasized the importance of well-fitted cushions for wheelchair users, as they help reduce the risk of pressure sores—wounds that can form from prolonged sitting.

While specific safety data for these cushions is lacking, their inclusion in a trial suggests they are generally considered safe. Designed to enhance comfort and prevent skin problems, they are likely easy to use.

It is important to note that these cushions are currently being tested in a trial, meaning their safety and effectiveness are still under evaluation. Participation in the trial will contribute valuable information about how these cushions perform in everyday life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GEL BALL and SQUISHINS fitted modular cushions because they offer a fresh approach to pressure relief for people with mobility impairments. Unlike traditional wheelchair cushions, which might use basic foam or air cells, these modular cushions are designed to fit the user's individual body shape more precisely, potentially enhancing comfort and reducing pressure points. The innovative use of gel balls and squishy, adaptive materials aims to offer improved support and pressure distribution, which could lead to better skin protection and reduced risk of pressure sores. This personalized fit and advanced material design are what set these cushions apart from standard options.

What evidence suggests that these modular cushions are effective for mobility impairment?

This trial will compare the effectiveness of two modular wheelchair cushions: the GEL BALL FITTED MODULAR CUSHION and the SQUISHINS FITTED MODULAR CUSHION. Studies have shown that modular wheelchair cushions like these can effectively relieve pressure for wheelchair users. Research indicates that these cushions change shape when sat upon, helping to distribute pressure more evenly. This feature can be especially beneficial for individuals at risk of pressure sores. Previous evaluations highlighted that these cushions are affordable and provide significant comfort, making them accessible to more people. Such personalized cushions have been tested and shown to maintain skin health and improve user satisfaction. ^{1 2 6 7 8}

Who Is on the Research Team?

Kath M. Bogie, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for veterans with mobility impairments who use a wheelchair full-time and are served through the LSCDVAMC Wheeled Mobility Clinic. Participants must be able to remain seated in their wheelchairs for more than 4 hours per day. Pregnant individuals cannot participate.

Inclusion Criteria

I am a veteran who uses a wheelchair full time and I get my care from the LSCDVAMC Wheeled Mobility Clinic.

Exclusion Criteria

I cannot stay seated in a wheelchair for more than 4 hours a day.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-baseline

Seated interface pressures assessed with participants sitting on their own cushions; pelvic region skin checks carried out

1 week

1 visit (in-person)

Treatment

Participants use personalized modular cushions for 2 weeks each, with continuous monitoring of microenvironmental conditions

4 weeks

2 visits (in-person) for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including skin health checks and user satisfaction questionnaire

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GEL BALL FITTED MODULAR CUSHION
• SQUISHINS FITTED MODULAR CUSHION

Trial Overview The study tests two types of personalized modular cushions: GEL BALL FITTED MODULAR CUSHION and SQUISHINS FITTED MODULAR CUSHION, over two weeks each on full-time wheelchair users to measure comfort, skin health, daily function, and cost-effectiveness.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 2 Interventions

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks followed by DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks

Group II: Group A Experimental Treatment 2 Interventions

DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks followed by DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965206X17300414

Preliminary development of an advanced modular ... High quality affordable wheelchair cushions could provide effective pressure relief for many individuals with limited access to advanced assistive technology.

2. withpower.com withpower.com/trial/phase-8-2021-90411

Modular Pressure Relief Cushions for Mobility Impairment ... What data supports the effectiveness of the treatment GEL BALL FITTED MODULAR CUSHION, SQUISHINS FITTED MODULAR CUSHION for mobility impairment? Research ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28343746/

Testing and user evaluation High quality affordable wheelchair cushions could provide effective pressure relief for many individuals with limited access to advanced assistive technology.

4. ctv.veeva.com ctv.veeva.com/study/user-evaluation-of-advanced-personalized-modular-pressure-relief-seating-cushion-systems

User Evaluation of Advanced Personalized Modular Pressure ... 30 Veterans who are full-time wheelchair users will use personalized modular cushions for two weeks each. Personalized cushions will be ...

5. etd.ohiolink.edu etd.ohiolink.edu/acprod/odb_etd/ws/send_file/send?accession=case1427894141&disposition=inline

RELIEVING WHEELCHAIR CUSHION The results are summarized in the tables below. Interface pressure data was also taken during all trials and used to fit the modular cushion to the RCLI (see.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658289/

OFF-LOADING PRESSURE RELIEF WITH FOAM CUT ... This paper investigates the effectiveness of using foam cut out cushions to relieve pressure on bony areas while sitting, especially for elderly wheelchair ...

7. asia-spinalinjury.org asia-spinalinjury.org/wp-content/uploads/2023/03/DME-2022-Booklet-10.20.22.pdf

DURABLE MEDICAL EqUIPMENT The american Spinal Injury association (“aSIa”) has made this guide available to provide information to the spinal cord injury community. reference in this ...

8. d-scholarship.pitt.edu d-scholarship.pitt.edu/35730/1/DesignConsiderations_WheelchairsAC_12142017.pdf

Design Considerations for Wheelchairs used in Adverse ... Folding frame wheelchairs typically are built with cross- braces to allow the chair to fold up and may make it easier to store or transport. Even folding chairs ...