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

Primary Purpose

Pressure Ulcer, Pressure Injury, Wheelchair

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensoria
AW-Shift
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure Injury, Pressure Ulcer, Weight Shift, Wheelchair, Pressure monitoring, Pressure relief

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgia Institute of Technology
  • University of Minnesota
  • Mayo Clinic
  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sensoria first intervention

AW-Shift first intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in in-seat movement between baseline and intervention
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2021
Last Updated
April 4, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), University of Minnesota, Georgia Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04934137
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), University of Minnesota, Georgia Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Pressure Injury, Wheelchair
Keywords
Pressure Injury, Pressure Ulcer, Weight Shift, Wheelchair, Pressure monitoring, Pressure relief

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensoria first intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AW-Shift first intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sensoria
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AW-Shift
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in in-seat movement between baseline and intervention
Description
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.
Time Frame
Intervention Phases 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hallbeck, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamara Vos-Draper, PhD, OT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Sonenblum, PhD
Organizational Affiliation
Georgia Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa Morrow, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Institute of Technology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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