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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX002434 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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 |
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| Group B | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of GEL BALL FITTED MODULAR CUSHION | Device | DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin health checks | Pelvic region skin checks will be carried out by the study Research Nurse to ensure there are no areas of redness or breakdown. | Before and after cushion use (2 week period) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kath M Bogie, PhD | Contact | (204) 778-3083 | Katherine.Bogie@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Kath M. Bogie, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
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Repeated measures crossover clinical study design
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| Use of SQUISHINS FITTED MODULAR CUSHION | Device | DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks |
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