User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems (Squishycushion)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mobility Impairment
• Intervention / Treatment: Device: Use of GEL BALL FITTED MODULAR CUSHION; Device: Use of SQUISHINS FITTED MODULAR CUSHION

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kath M Bogie, PhD; Phone Number: (204) 778-3083; Email: Katherine.Bogie@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Contact: Kath M Bogie, PhD; Phone Number: 204-778-3083; Email: Katherine.Bogie@va.gov
      • Principal Investigator: Kath M. Bogie, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks followed by DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks	Device: Use of GEL BALL FITTED MODULAR CUSHION; DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks; Device: Use of SQUISHINS FITTED MODULAR CUSHION; DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks
Experimental: Group B; DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks followed by DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks	Device: Use of GEL BALL FITTED MODULAR CUSHION; DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks; Device: Use of SQUISHINS FITTED MODULAR CUSHION; DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Continuously during each 2 week period of cushion use
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.	Continuously during each 2 week period of cushion use
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.	After each 2 week period of cushion use for 5 minutes at each assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User satisfaction questionnaire	Questionnaire based on the QUEST 2.0 user satisfaction instrument	After each 2 week period of cushion use for 5 minutes at each assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before and after cushion use (2 week period)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kath M. Bogie, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Estimated): August 23, 2026
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: wheelchair seating; tissue health
• Other Study ID Numbers: A2434-R; I01RX002434 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No