N/A
N=46
Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
Pressure Ulcer · Pressure Injury · Wheelchair
Bottom Line
View on ClinicalTrials.gov: NCT04934137 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Normalized Weight Shift Frequency (Weight Shifts/Hour) — 2.41; 2.38 normalized weight shifts per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sensoria (Behavioral); AW-Shift (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalized Weight Shift Frequency (Weight Shifts/Hour) |
2.41; 2.38 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04934137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.