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

• ClinicalTrials.gov Identifier: NCT04934137
• Recruitment Status: Completed
• First Posted: June 22, 2021
• Last Update Posted: April 6, 2023
• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA); University of Minnesota; Georgia Institute of Technology
• Information provided by (Responsible Party): Susan Hallbeck, Ph.D., Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pressure Ulcer; Pressure Injury; Wheelchair	Behavioral: Sensoria; Behavioral: AW-Shift	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
• Actual Study Start Date: March 17, 2022
• Actual Primary Completion Date: January 20, 2023
• Actual Study Completion Date: January 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sensoria first intervention; 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; 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.
Active Comparator: AW-Shift first intervention; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in in-seat movement between baseline and intervention [ Time Frame: Intervention Phases 1 and 2 ]
   The difference in average weight shift frequencies per hour of wheelchair occupancy between the baseline phase and the intervention phases will be calculated to determine if having an intervention increased in-seat movement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Georgia Institute of Technology

Atlanta, Georgia, United States, 30332

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Texas

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Sponsors and Collaborators

Mayo Clinic

National Institute on Aging (NIA)

University of Minnesota

Georgia Institute of Technology

Investigators

• Principal Investigator: 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

  Study Documents (Full-Text)

Documents provided by Susan Hallbeck, Ph.D., Mayo Clinic:

Informed Consent Form  [PDF] September 27, 2022

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Susan Hallbeck, Ph.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04934137
• Other Study ID Numbers: 19-008916; R01AG056255 ( U.S. NIH Grant/Contract )
• First Posted: June 22, 2021
• Last Update Posted: April 6, 2023
• Last Verified: April 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Hallbeck, Ph.D., Mayo Clinic:

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

Additional relevant MeSH terms:

Pressure Ulcer; Wounds and Injuries; Crush Injuries; Skin Ulcer; Skin Diseases