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User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems (Squishycushion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494127
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Mobility Impairment Device: Use of GEL BALL FITTED MODULAR CUSHION Device: Use of SQUISHINS FITTED MODULAR CUSHION Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Repeated measures crossover clinical study design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: 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
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

Experimental: 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
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 :
  1. Seated interface pressure distribution [ Time Frame: After each 2 week period of cushion use for 5 minutes at each assessment ]
    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.

  2. Microenvironmental status I - temperature [ Time Frame: Continuously during each 2 week period of cushion use ]
    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.

  3. Microenvironmental status II - humidity [ Time Frame: Continuously during each 2 week period of cushion use ]
    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.


Secondary Outcome Measures :
  1. User satisfaction questionnaire [ Time Frame: After each 2 week period of cushion use for 5 minutes at each assessment ]
    Questionnaire based on the QUEST 2.0 user satisfaction instrument


Other Outcome Measures:
  1. Skin health checks [ Time Frame: Before and after cushion use (2 week period) ]
    Pelvic region skin checks will be carried out by the study Research Nurse to ensure there are no areas of redness or breakdown.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494127


Contacts
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Contact: Kath M Bogie, PhD (204) 778-3083 Katherine.Bogie@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Contact: Kath M Bogie, PhD    204-778-3083    Katherine.Bogie@va.gov   
Principal Investigator: Kath M. Bogie, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Kath M. Bogie, PhD Louis Stokes VA Medical Center, Cleveland, OH
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03494127    
Other Study ID Numbers: A2434-R
I01RX002434 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
wheelchair seating
tissue health