User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Mobility Impairment Clinical Trial

— Squishycushion  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03494127
• Other study ID #: A2434-R
• Secondary ID: I01RX002434
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 23, 2024
• Est. completion date: September 30, 2028

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Kath M Bogie, PhD
• Phone: (204) 778-3083
• Email: Katherine.Bogie[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2028
• Est. primary completion date: December 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Impairment

Intervention

Device:
• Use of GEL BALL FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
• Use of SQUISHINS FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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
Primary	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
Primary	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
Secondary	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