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

NCT04934137 | Completed Results

• 2 other identifiers: 19-008916R01AG056255
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

Pressure Ulcer; Pressure Injury; Wheelchair

Keywords

Pressure Injury; Pressure Ulcer; Weight Shift; Wheelchair; Pressure monitoring; Pressure relief

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Sensoria first intervention

ACTIVE COMPARATOR

Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks.

Behavioral: Sensoria; Behavioral: AW-Shift

AW-Shift first intervention

ACTIVE COMPARATOR

Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks.

Behavioral: Sensoria; Behavioral: AW-Shift

Interventions

Sensoria BEHAVIORAL

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 first intervention; Sensoria first intervention

AW-Shift BEHAVIORAL

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.

AW-Shift first intervention; Sensoria first intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator
• University of Minnesota: collaborator
• Georgia Institute of Technology: collaborator

Study Sites (4)

Georgia Institute of Technology

Atlanta, Georgia, 30332, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Melissa Morrow
• Organization: University of Texas Medical Branch

memorrow@utmb.edu

409-266-0344

Study Officials

• Susan Hallbeck, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Tamara Vos-Draper, PhD, OT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Sharon Sonenblum, PhD

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

• Melissa Morrow, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: March 17, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-01

Locations

US (4)