Clinical trial NCT04934137: Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
Official title: Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Wheelchair
Keywords: Pressure Injury
Pressure Ulcer
Weight Shift
Wheelchair
Pressure monitoring
Pressure relief
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Minnesota
name: Georgia Institute of Technology
First posted: 2021-06-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Normalized Weight Shift Frequency (Weight Shifts/Hour)
timeFrame: The outcome measure was assessed at week 4 (the end) of each intervention period.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Institute of Technology
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Susan Hallbeck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Tamara Vos-Draper, PhD, OT
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia Institute of Technology
name: Sharon Sonenblum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Melissa Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
References: