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User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

ConditionMobility Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.

Disqualifiers

Pregnancy

Inability to remain seated in the wheelchair for more than 4 hours/day

Trial design

Design model

Crossover

Treatments tested in this trial

  • Use of GEL BALL FITTED MODULAR CUSHION

    Device

    DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks

  • Use of SQUISHINS FITTED MODULAR CUSHION

    Device

    DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
After each 2 week period of cushion use for 5 minutes at each assessment
2

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.

Time frame
Continuously during each 2 week period of cushion use
3

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.

Time frame
Continuously during each 2 week period of cushion use

Secondary outcomes

1

User satisfaction questionnaire

Questionnaire based on the QUEST 2.0 user satisfaction instrument

Time frame
After each 2 week period of cushion use for 5 minutes at each assessment

Other outcomes

1

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.

Time frame
Before and after cushion use (2 week period)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: