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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04934137
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase N/A
Start date March 17, 2022
Completion date January 20, 2023

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