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User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

NCT03494127 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-18

No results posted yet for this study

Summary

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.

Conditions

  • Mobility Impairment

Interventions

DEVICE

Use of GEL BALL FITTED MODULAR CUSHION

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

DEVICE

Use of SQUISHINS FITTED MODULAR CUSHION

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Kath M. Bogie, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-23
Primary Completion
2027-12-28
Completion
2028-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494127 on ClinicalTrials.gov