User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-23

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CMAP Refinement for Pressure Injury Prevention

NCT04309864

Pressure Ulcer

COMPLETED NA

Wheelchair Cushion Comparison Study: SAFETY

NCT03430375

Spinal Cord Injuries Stroke Healthy Adults

COMPLETED NA

Wheelchair Positioning and Neuromuscular Diseases

NCT05006859

Neuromuscular Diseases

RECRUITING

Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users

NCT04934137

Pressure Ulcer Pressure Injury Wheelchair

COMPLETED NA

Understanding Quality and Equity in Wheelchairs for Veterans

NCT01236170

Spinal Cord Injuries Amputees

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mobility Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Repeated measures crossover clinical study design

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Use of GEL BALL FITTED MODULAR CUSHION

Intervention Type DEVICE

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

Use of SQUISHINS FITTED MODULAR CUSHION

Intervention Type DEVICE

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

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

Group Type EXPERIMENTAL

Use of GEL BALL FITTED MODULAR CUSHION

Intervention Type DEVICE

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

Use of SQUISHINS FITTED MODULAR CUSHION

Intervention Type DEVICE

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Use of GEL BALL FITTED MODULAR CUSHION

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

Intervention Type DEVICE

Use of SQUISHINS FITTED MODULAR CUSHION

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.