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Seating Cushion

Modular Pressure Relief Cushions for Mobility Impairment (Squishycushion Trial)

N/A

Waitlist Available

Led By Kath M. Bogie, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after each 2 week period of cushion use for 5 minutes at each assessment

Awards & highlights

Squishycushion Trial Summary

This trial will test the feasibility, safety, and effectiveness of personalized modular cushions for full-time wheelchair users.

Who is the study for?

This trial is for veterans with mobility impairments who use a wheelchair full-time and are served through the LSCDVAMC Wheeled Mobility Clinic. Participants must be able to remain seated in their wheelchairs for more than 4 hours per day. Pregnant individuals cannot participate.Check my eligibility

What is being tested?

The study tests two types of personalized modular cushions: GEL BALL FITTED MODULAR CUSHION and SQUISHINS FITTED MODULAR CUSHION, over two weeks each on full-time wheelchair users to measure comfort, skin health, daily function, and cost-effectiveness.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort or skin issues due to prolonged seating if the cushion does not provide adequate pressure relief or support.

Squishycushion Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran who uses a wheelchair full time and I get my care from the LSCDVAMC Wheeled Mobility Clinic.

Squishycushion Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after each 2 week period of cushion use for 5 minutes at each assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after each 2 week period of cushion use for 5 minutes at each assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after each 2 week period of cushion use for 5 minutes at each assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Microenvironmental status I - temperature

Microenvironmental status II - humidity

Seated interface pressure distribution

Secondary outcome measures

User satisfaction questionnaire

Other outcome measures

Skin health checks

Squishycushion Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

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 II: Group AExperimental Treatment2 Interventions

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,573 Total Patients Enrolled

Kath M. Bogie, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

3 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

GEL BALL FITTED MODULAR CUSHION (Seating Cushion) Clinical Trial Eligibility Overview. Trial Name: NCT03494127 — N/A

Mobility Impairment Research Study Groups: Group B, Group A

Mobility Impairment Clinical Trial 2023: GEL BALL FITTED MODULAR CUSHION Highlights & Side Effects. Trial Name: NCT03494127 — N/A

GEL BALL FITTED MODULAR CUSHION (Seating Cushion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03494127 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots left for this research endeavor?

"The clinicaltrials.gov entry reveals that this particular research project is not presently searching for participants as it was last updated on September 22nd 2022. However, there are two other studies actively recruiting patients at the time of writing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

2024. "User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03494127.