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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

30 Veterans who are full-time wheelchair users will use personalized modular cushions for two weeks each. Personalized cushions will be created using a cushion fitting process the investigators have already developed and tested. Microenvironmental conditions will be monitored during use. A cost analysis will ensure the customized modular cushion applies value-driven principles. User satisfaction will be measured along with the effects on daily function, skin status and seated tissue health.

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 data supports the effectiveness of the treatment GEL BALL FITTED MODULAR CUSHION, SQUISHINS FITTED MODULAR CUSHION for mobility impairment?

Research shows that modular wheelchair cushions, like the ones being studied, can improve pressure relief and comfort for people with mobility issues. These cushions are designed to prevent pressure sores by distributing weight more evenly, and they can be customized to meet individual needs, which may enhance their effectiveness. ^{1 2 3 4 5}

Is the Modular Pressure Relief Cushion safe for use in humans?

The research does not provide specific safety data for the Modular Pressure Relief Cushion or its variants, but it does explore how different cushion materials affect pressure distribution, which is important for preventing pressure ulcers. No safety concerns were reported in the studies, suggesting that these types of cushions are generally safe for use in humans. ^{6 7 8 9 10}

How is the Modular Pressure Relief Cushion treatment different from other treatments for mobility impairment?

The Modular Pressure Relief Cushions, like the GEL BALL FITTED and SQUISHINS FITTED, are unique because they combine different materials to improve comfort and pressure relief for people with mobility impairments. Unlike standard cushions, these modular designs allow for customization to meet individual needs, offering better stability and temperature control. ^{1 2 3 4 11}

Research Team

Kath M. Bogie, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Preliminary development of an advanced modular pressure relief cushion: Testing and user evaluation. [2018]

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

Development of a modular wheelchair cushion for spinal cord injured persons. [2006]

3. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of wheelchair cushions by means of pressure distribution mapping. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating the impact of WaterCell® Technology on pressure redistribution and comfort/discomfort of adults with limited mobility. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The Flo-tech range of pressure-reducing cushions. [2017]

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

Pressure distribution at the seating interface of custom-molded wheelchair seats: effect of various materials. [2019]

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

Do pressure relief cushions really relieve pressure? [2017]

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

Effect of model design, cushion construction, and interface pressure mats on interface pressure and immersion. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Procedure to categorize wheelchair cushion performance using compliant buttock models. [2022]

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

Anthropomorphic model rigid loading indenter with embedded sensor development for wheelchair cushion standard testing. [2023]

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

Wheelchair cushion. [2016]