Menu
Not yet recruiting NCT03494127

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

No phase Interventional Mobility Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of GEL BALL FITTED MODULAR CUSHION, Use of SQUISHINS FITTED MODULAR CUSHION.
Who it may be relevant to
Registry conditions: Mobility Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Seated interface pressure distribution [Time frame: After each 2 week period of cushion use for 5 minutes at each assessment]
  • Microenvironmental status I - temperature [Time frame: Continuously during each 2 week period of cushion use]
  • Microenvironmental status II - humidity [Time frame: Continuously during each 2 week period of cushion use]
Secondary outcome measures (1)
  • User satisfaction questionnaire [Time frame: After each 2 week period of cushion use for 5 minutes at each assessment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland

Identifiers

NCT: NCT03494127 · A2434-R · I01RX002434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗