Mobility Impairment
Conditions
Keywords
wheelchair seating, tissue health
Brief 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.
Interventions
DEVICEUse of GEL BALL FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
DEVICEUse of SQUISHINS FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Repeated measures crossover clinical study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seated interface pressure distribution | After each 2 week period of cushion use for 5 minutes at each assessment | 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. |
| Microenvironmental status I - temperature | Continuously during each 2 week period of cushion use | 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. |
| Microenvironmental status II - humidity | Continuously during each 2 week period of cushion use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User satisfaction questionnaire | After each 2 week period of cushion use for 5 minutes at each assessment | Questionnaire based on the QUEST 2.0 user satisfaction instrument |
Countries
United States
Contacts
CONTACTKath M Bogie, PhD
PRINCIPAL_INVESTIGATORKath M. Bogie, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Outcome results
None listed