Clinical trial NCT03494127: User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
Official title: Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobility Impairment
Keywords: wheelchair seating
tissue health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures crossover clinical study design
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seated interface pressure distribution
timeFrame: After each 2 week period of cushion use for 5 minutes at each assessment
measure: Microenvironmental status I - temperature
timeFrame: Continuously during each 2 week period of cushion use
measure: Microenvironmental status II - humidity
timeFrame: Continuously during each 2 week period of cushion use
Secondary outcomes:
measure: User satisfaction questionnaire
timeFrame: After each 2 week period of cushion use for 5 minutes at each assessment
Other outcomes:
measure: Skin health checks
timeFrame: Before and after cushion use (2 week period)
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Kath M. Bogie, PhD
role: PRINCIPAL_INVESTIGATOR
References: