NCT03494127

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A repeated measures clinical study design will be carried out with 30 Veterans. 'Pre-baseline' seated interface pressures will be assessed with study participants sitting on their own cushions and pelvic region skin checks carried out by the study Research Nurse. All participants will then receive customized modular cushions. Participants will be randomly assigned to Group A or Group B using a modified randomization scheme. Group A participants will first use a gel ball fitted cushion for 2 weeks during all daily living activities while seated in their wheelchair followed by use of a SquishINS fitted cushion for 2 weeks. Group B will first use the SquishINS fitted cushion then a gel ball fitted cushion. Seated interface pressure distribution will be obtained at the beginning and end of each test period. A dual temperature and humidity sensor placed in the cushion will enable continuous monitoring of microenvironmental status during use. The study Research Nurse will repeat the pelvic region skin check and participants will complete a questionnaire based on the QUEST 2.0 user satisfaction instrument. All responses will be documented as part of the QS/DC program.

Conditions

• Mobility Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-08-23
• Primary completion: 2027-12-28
• Completion: 2028-09-30
• First posted: 2018-04-11
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States