User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mobility Impairment

Intervention / Treatment
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* Device: Use of GEL BALL FITTED MODULAR CUSHION
* Device: Use of SQUISHINS FITTED MODULAR CUSHION


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Repeated measures crossover clinical study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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 | Device: Use of GEL BALL FITTED MODULAR CUSHION<br>* DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks<br>Device: Use of SQUISHINS FITTED MODULAR CUSHION<br>* DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks<br>|
| Experimental: Group B<br>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 | Device: Use of GEL BALL FITTED MODULAR CUSHION<br>* DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks<br>Device: Use of SQUISHINS FITTED MODULAR CUSHION<br>* DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated interface pressure distribution | 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. | After each 2 week period of cushion use for 5 minutes at each assessment | 
| Microenvironmental status I - temperature | 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. | Continuously during each 2 week period of cushion use | 
| Microenvironmental status II - humidity | 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. | Continuously during each 2 week period of cushion use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User satisfaction questionnaire | Questionnaire based on the QUEST 2.0 user satisfaction instrument | After each 2 week period of cushion use for 5 minutes at each assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheelchair seating, tissue health