Evaluation of Wheelchair In-Seat Activity Tracker (WiSAT)

Evaluation of the Wheelchair In-Seat Activity Tracker (WiSAT)

Individuals who use wheelchairs are at an increased risk of developing pressure injuries on the parts of the body that are in constant contact with the wheelchair. The development of pressure injuries can cause reduced mobility, reduced activity and participation, greater unemployment, increased risk for future pressure injury development, and premature death. There are numerous risk factors associated with developing pressure injuries. Individuals can reduce the risk of pressure injury formation by changing positions, weight-shifting, and using special cushions, but many people still struggle with pressure injuries.

This study is designed to assess the clinical effectiveness of WiSAT (Wheelchair in-Seat Activity Tracker). WiSAT is a tool designed to help prevent the development of pressure ulcers by changing behaviors that can lead to pressure ulcers. WiSAT monitors and provides real-time feedback on weight shifts and pressure relief behaviors while sitting in a wheelchair.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer; Pressure Injury; Pressure Ulcer, Buttock
• Intervention / Treatment: Other: WiSAT System, Passive Feedback; Other: WiSAT System, Active Feedback

Detailed Description

Pressure injuries are a serious health concern for individuals who use wheelchairs. Wheelchair users are at an increased risk of developing pressure injuries on the parts of the body that are in constant contact with the wheelchair. The development of pressure injuries can cause negative consequences on their lives. Pressure injuries often lead to reduced mobility, reduced activity and participation, greater unemployment, increased risk for future pressure injury development, and premature death. Some risk factors associated with developing pressure injuries include continual pressure, nutrition, shear forces, and moisture. Individuals whose use wheelchairs can reduce the risk of pressure injury formation by changing positions, weight-shifting, and using skin protection cushions, but many people still struggle with pressure injuries.

This study will assess the clinical effectiveness and usability of WiSAT (Wheelchair in-Seat Activity Tracker). WiSAT provides real-time feedback on in-seat movement, including volitional pressure reliefs and weight-shift activity. The study's aim is to assess whether monitoring and feedback of in-seat movement can change the behavior of wheelchair users by increasing movement activities.

Study Protocol: The study will prospectively collect in-seat movement activity during everyday life for wheelchair users at risk for pressure ulcers. 25 individuals who are full-time users of wheelchairs and have a self-reported risk for pressure ulcers on the buttocks (sacrum/coccyx, ischial tuberosity, trochanter) will be recruited for the study.

Each person will have two appointments with investigators to educate, set them up with the WiSAT system and finally to remove the sensor system from the cushion.

The first visit will take approximately 1.5 to 2 hours, in which participants will provide written informed consent. During this visit, demographic and clinical information will be collected via self-report. All participants will then receive education about skin health including information about pressure ulcers, prevention strategies such as pressure relieving techniques in both bed and wheelchair, and the importance of checking skin regularly for signs of pressure issues. The WiSAT hardware will be placed within the cover and beneath their current wheelchair cushion to measure and transmit baseline seat movement activity; with no mobile application and visual feedback initiated at this time. Subjects' baseline behavior will be monitored for two weeks to serve as the comparator for the enabled WiSAT system.

After 14 days of baseline monitoring, the app will automatically switch to feedback mode. Participants will be informed that they can now monitor their movement activity. Each subject will be given the ability to set his or her own goals using the app settings. The movement activity feedback will be provided passively for four weeks, requiring them to view the application on their smartphone to see daily movement activity data.

After the four weeks of app use, recorded movement activity will be used to categorize participants as meeting or not meeting the movement threshold. Subjects who do not attain their movement threshold will be provided with active feedback using audible and/or haptic reminders. Those who have reached their threshold will continue to access the app to review their activity (passive feedback).

All participants will be followed for a total of 2.5 months: 2 weeks baseline, 4 weeks passive visual feedback only, and 4 weeks of passive and/or active feedback. At the end of the study, the team will collect feedback on usability and acceptability of the activity tracker.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141
      • Edward Hines, Jr. VA Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Use a wheelchair as their primary means of mobility
• Have a self-reported history of pressure ulcers on the buttocks within the past three years
• Age 18 or older
• Use a smartphone with an operating system upgraded in the last 5 years
• Use a skin protection cushion or skin protection/positioning cushion

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WiSAT Passive; This arm is composed of participants who meet their activity threshold over the 4-week period.	Other: WiSAT System, Passive Feedback; The WiSAT system is installed in the participant's wheelchair cushion and a smartphone application is installed on his/her cellphone. Participants are able to view the application as they please and they will receive no notifications from the app regarding their movement goals.
Other: WiSAT Active; This arm is composed of participants who do not meet their activity threshold over the 4-week period.	Other: WiSAT System, Active Feedback; The WiSAT system is installed in the participant's wheelchair cushion and smartphone application is installed on his/her cellphone. Participants receive notifications from the app to help them meet their movement goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in average daily movement activity at 5 months	Average daily movement activity is defined as the frequency of in-seat movement will be calculated as total number of weight shifts and pressure reliefs per unit time of wheelchair use (movements/hour).	baseline (2 weeks) and 5 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: United States Department of Defense; Georgia Institute of Technology
• Investigators: Study Director: Patricia E Karg, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Wounds and Injuries; Skin Ulcer; Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: STUDY19090305; W81XWH-17-1-0221 (Other Grant/Funding Number: Department of Defense (DoD))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified research data may in the future be shared upon request with investigators external to the study team who are conducting similar research with an approved IRB. Research data including time in wheelchair, weight shift frequency, and demographics may be shared.
• IPD Sharing Time Frame: Any time after primary and secondary publications
• IPD Sharing Access Criteria: To be determined.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No