NCT03494127

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
8.4 years until next milestone

Study Start

First participant enrolled

August 23, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2027

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

March 27, 2018

Last Update Submit

July 17, 2025

Conditions

Mobility Impairment

Keywords

wheelchair seatingtissue health

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

Secondary Outcomes (1)

  • User satisfaction questionnaire

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

Other Outcomes (1)

  • Skin health checks

    Before and after cushion use (2 week period)

Study Arms (2)

Group A

EXPERIMENTAL

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 CUSHIONDevice: Use of SQUISHINS FITTED MODULAR CUSHION

Group B

EXPERIMENTAL

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 CUSHIONDevice: Use of SQUISHINS FITTED MODULAR CUSHION

Interventions

Use of GEL BALL FITTED MODULAR CUSHIONDEVICE

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

Group AGroup B
Use of SQUISHINS FITTED MODULAR CUSHIONDEVICE

DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Inability to remain seated in the wheelchair for more than 4 hours/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Study Officials

  • Kath M. Bogie, PhD

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kath M Bogie, PhD

CONTACT

(204) 778-3083Katherine.Bogie@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: Repeated measures crossover clinical study design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 11, 2018

Study Start (Estimated)

August 23, 2026

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)