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NCT Number: NCT03494127

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location contact

Kath M Bogie, PhD

CONTACT

[email protected]

204-778-3083

Kath M. Bogie, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Seated interface pressure distribution

    Time frame: 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.

  2. Microenvironmental status I - temperature

    Time frame: 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.

  3. Microenvironmental status II - humidity

    Time frame: 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 outcomes

  1. User satisfaction questionnaire

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

    Questionnaire based on the QUEST 2.0 user satisfaction instrument

Other outcomes

  1. Skin health checks

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

    Pelvic region skin checks will be carried out by the study Research Nurse to ensure there are no areas of redness or breakdown.

Study contacts

Contact information is provided by the study sponsor or research team.

Kath M Bogie, PhD

CONTACT

[email protected]

(204) 778-3083

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation

Acronym: Squishycushion

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2018
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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