User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT03494127
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Mobility Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of GEL BALL FITTED MODULAR CUSHION — DEVICE
    DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
  • Use of SQUISHINS FITTED MODULAR CUSHION — DEVICE
    DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Study Details

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.

Key Dates

Start date
Aug 23, 2026
Status verified
Jul 2025
Primary completion
Dec 28, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Group A
    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
  • Experimental: Group B
    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

Primary Outcome Measure

Seated interface pressure distribution [ Time Frame: After each 2 week period of cushion use for 5 minutes at each assessment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Kath M Bogie, PhD
[email protected]
204-778-3083
Kath M. Bogie, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

Related Studies