Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users

Pressure Ulcer Clinical Trial

Official title:

Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934137
• Other study ID #: 19-008916
• Secondary ID: R01AG056255
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

For almost 50 years, clinicians and researchers have been interested in devices to monitor pressure and weight shift frequency, send alerts, provide cues, or track movement patterns in wheelchair users. Despite the prevention efforts implemented over the years, pressure injuries continue to occur at a high rate of incidence. Without sensation to guide the need for changes in position to alleviate pressure, individuals with decreased sensation move significantly less than individuals with normal sensory systems. Thus, movement is a potentially robust protective factor to target. When focusing on movement as a modifiable risk factor, there is evidence that more in-seat movement is protective in wheelchair users. Behaviors, such as weight shifting to relieve pressure, decay over time, which could be attributed to lack of sensation to provide a natural cue to move. More work is needed to understand the types of movement that are most beneficial, and how to empower wheelchair users to move more often. Our hypotheses are that A) Individuals will complete more frequent and more consistent weight shifts with access to the feedback systems compared to baseline and B) Self-efficacy beliefs for completing weight shifts will increase with use of the feedback systems. This study will examine the effects of two novel seat mapping technologies ("AW-Shift" and "WiSAT") 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 rich visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. WiSAT 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. The successful completion of this project will make large advancements in optimizing feedback about pressure and movement that will help wheelchair users become more effective in managing pressure distribution on an ongoing, daily basis.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer
• Wheelchair
• Wounds and Injuries

Intervention

Behavioral:
• Sensoria
The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes.
• AW-Shift
The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Georgia Institute of Technology, National Institute on Aging (NIA), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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.

External Links

•   Mayo Clinic Clinical Trials