User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

This study is looking for 30 Veterans with mobility impairments who use a power or manual wheelchair full-time. The goal is to test two different types of personalized modular cushions: the GEL BALL FITTED MODULAR CUSHION and the SQUISHINS FITTED MODULAR CUSHION. You would use each cushion for two weeks in your daily life. Researchers will measure how pressure is distributed when you sit, and continuously monitor the temperature and humidity around the cushion. They will also check your skin and ask about your satisfaction with the cushions. This helps them understand how well these cushions work to improve comfort and skin health.

Study design
This is an interventional study with 30 participants. You would be randomly assigned to use the cushions in a specific order.
What's involved
You would use each of two different personalized cushions for two weeks each, for a total of four weeks. There will be assessments of your seated pressure and skin checks at the beginning and end of each two-week period, and you will complete a satisfaction questionnaire.
Compensation
Not stated in the trial record.
Follow-up
Your seated interface pressure distribution will be measured after each two-week period of cushion use. Microenvironmental status (temperature and humidity) will be continuously monitored during each two-week period of cushion use.

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NCT03494127

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
VA Office of Research and Development
~30 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Use of GEL BALL FITTED MODULAR CUSHIONUse of SQUISHINS FITTED MODULAR CUSHION

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Seated interface pressure distribution
Measured over After each 2 week period of cushion use for 5 minutes at each assessment
+2 more outcomes measured
Mobility Impairment
1 sites across 1 states
Ohio1
  • Kath M. Bogie, PhD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center, Cleveland, OH

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Eligibility criteria

Inclusion

Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.

Exclusion

Pregnancy
Inability to remain seated in the wheelchair for more than 4 hours/day
  • Seated interface pressure distributionAfter each 2 week period of cushion use for 5 minutes at each assessment

    Interface pressure distribution (mmHg) will be recorded using the Tekscan CONFORMat® Pressure Measurement System. Real-time 3-D images of pressure distribution at the seating interface are produced using graphical display software.

  • Microenvironmental status I - temperatureContinuously during each 2 week period of cushion use

    A dual temperature and humidity sensor will be placed in the cushion for continuous monitoring of microenvironmental status. At the end of each test period, microenvironmental temperature status data (deg C) will be downloaded for analysis.

  • Microenvironmental status II - humidityContinuously during each 2 week period of cushion use

    A dual temperature and humidity sensor will be placed in the cushion for continuous monitoring of microenvironmental status. At the end of each test period, microenvironmental humidity status data (relative humidity units) will be downloaded for analysis.