Pressure Ulcer Clinical Trial
Official title:
Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | January 20, 2023 |
Est. primary completion date | January 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Institute of Technology | Atlanta | Georgia |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Georgia Institute of Technology, National Institute on Aging (NIA), University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normalized Weight Shift Frequency (Weight Shifts/Hour) | The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase. | The outcome measure was assessed at week 4 (the end) of each intervention period. |
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