Mobility ImpairmentSquishycushionNCT03494127
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
A study testing Use of GEL BALL FITTED MODULAR CUSHION and Use of SQUISHINS FITTED MODULAR CUSHION in people with Mobility Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility Impairment
- What is being tested?
- Use of GEL BALL FITTED MODULAR CUSHION and Use of SQUISHINS FITTED MODULAR CUSHION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2027to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.
Who cannot join
- Pregnancy
- Inability to remain seated in the wheelchair for more than 4 hours/day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Kath M Bogie, PhD, (204) 778-3083, Katherine.Bogie@va.gov
Kath M. Bogie, PhD
About this study
Official title: Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation
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.
Read the 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.
- Conditions
- Mobility Impairment
- Being tested
- Use of GEL BALL FITTED MODULAR CUSHION, Use of SQUISHINS FITTED MODULAR CUSHION
- Keywords
- wheelchair seating, tissue health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of GEL BALL FITTED MODULAR CUSHIONDevice
DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
Use of SQUISHINS FITTED MODULAR CUSHIONDevice
DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Use of GEL BALL FITTED MODULAR CUSHION; Device: 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 Receives: Device: Use of GEL BALL FITTED MODULAR CUSHION; Device: Use of SQUISHINS FITTED MODULAR CUSHION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Continuously during each 2 week period of cushion use
Secondary outcomes (1)
User satisfaction questionnaire
Questionnaire based on the QUEST 2.0 user satisfaction instrument
Measured: After each 2 week period of cushion use for 5 minutes at each assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start23 Aug 2027 (estimated)
- Primary completion28 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures crossover clinical study design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kath M. Bogie, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494127
- Sponsor's protocol ID
- A2434-R
- Other IDs
- I01RX002434
- Acronym
- Squishycushion
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2018
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation
- ClinicalTrials.gov ID
- NCT03494127
- Acronym / sponsor ID
- Squishycushion / A2434-R
- Conditions
- Mobility Impairment
- Keywords
- wheelchair seating, tissue health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Aug 2027 (estimated)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeated measures crossover clinical study design
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Use of GEL BALL FITTED MODULAR CUSHION, Device: Use of SQUISHINS FITTED MODULAR CUSHIONDAILY 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 B | Experimental | Device: Use of GEL BALL FITTED MODULAR CUSHION, Device: Use of SQUISHINS FITTED MODULAR CUSHIONDAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks followed by DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.
Key exclusion criteria (2 listed)
- Pregnancy
- Inability to remain seated in the wheelchair for more than 4 hours/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of GEL BALL FITTED MODULAR CUSHIONDAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks | Device | Group A, Group B |
| Use of SQUISHINS FITTED MODULAR CUSHIONDAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks | Device | Group A, Group B |
Primary outcome
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.
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.
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.
1 secondary outcome
User satisfaction questionnaire
Time frame: After each 2 week period of cushion use for 5 minutes at each assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kath M. Bogie, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of GEL BALL FITTED MODULAR CUSHION and Use of SQUISHINS FITTED MODULAR CUSHION in people with Mobility Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kath M Bogie, PhD ((204) 778-3083, Katherine.Bogie@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seated interface pressure distribution (time frame: After each 2 week period of cushion use for 5 minutes at each assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.