User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | September 1, 2019 |
| End Date: | December 31, 2020 |
| Contact: | Kath M Bogie, PhD |
| Email: | Katherine.Bogie@va.gov |
| Phone: | (204) 778-3083 |
Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation
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.
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.
'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.
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
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Kath M. Bogie, PhD
Phone: 204-778-3083
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