User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems (Squishycushion)

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Mobility Impairment

Treatments: Device: Use of SQUISHINS FITTED MODULAR CUSHION; Device: Use of GEL BALL FITTED MODULAR CUSHION

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03494127

I01RX002434 (U.S. NIH Grant/Contract)

A2434-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Inability to remain seated in the wheelchair for more than 4 hours/day

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: Use of GEL BALL FITTED MODULAR CUSHION

Device: Use of SQUISHINS FITTED MODULAR CUSHION

Group B

Experimental group

Description:

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

Treatment:

Device: Use of GEL BALL FITTED MODULAR CUSHION

Device: Use of SQUISHINS FITTED MODULAR CUSHION