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

NCT04934137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-02-20

Study results available
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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.

Conditions

  • Pressure Ulcer
  • Pressure Injury
  • Wheelchair

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Susan Hallbeck, PhD · Mayo Clinic

  • Tamara Vos-Draper, PhD, OT · University of Minnesota

  • Sharon Sonenblum, PhD · Georgia Institute of Technology

  • Melissa Morrow, PhD · University of Texas

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2023-01-20
Completion
2023-01-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934137 on ClinicalTrials.gov