Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Inj… (NCT04934137) | Clinical Trial Compass
CompletedNot Applicable
Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
United States46 participantsStarted 2022-03-17
Plain-language summary
Pressure-related injuries in individuals with SCI and persons who use wheelchairs are one of the most dangerous secondary health problems encountered throughout the lifespan. With recurrence rates as high as 79% and mortality rates as high as 48% when sepsis is present, there exists a critical clinical need to target prevention of pressure injuries.
This study will examine the effects of two novel seat mapping technologies ("AW-Shift" and "Sensoria") on increasing in-seat movement in persons who may be at risk for pressure injuries due to altered sensation on their sitting surface. AW-Shift provides a visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. Sensoria represents a novel technology to promote tissue health by providing users with information about their daily in-seat movement and providing weight shift reminders that are based on time since previous weight shift activities. Changes in the frequency of in-seat movement behaviors will be compared between baseline and each intervention period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Be able to come to Mayo Clinic, UMN, or Georgia Tech campuses for study visits, or participate in virtual video study visits;
* Use a skin protection and positioning wheelchair cushion;
* Be able to perform weight shifts independently without assistance of another person (by moving themselves or using of power tilt);
* Own and are able to operate a smartphone with Apple or Android operating system;
* Are willing to download and use the mobile apps on their phone
Exclusion Criteria:
* Are scheduled for flap surgery;
* There is an active stage 3, 4, or unstageable pressure injury as defined by the National Pressure Injury Advisory Panel definitions anywhere on their sitting surface at time of enrollment;
* Use of a custom molded wheelchair cushion or alternating air cushion;
* Have/use the recline function on their manual or power wheelchair;
* Have a prescribed or limited sitting time of less than 5 hours per day;
* Live in a long-term care facility or group home and require 24 hours/day assistance;
* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Normalized Weight Shift Frequency (Weight Shifts/Hour)
Timeframe: The outcome measure was assessed at week 4 (the end) of each intervention period.