Evaluation of Wheelchair In-Seat Activity Tracker
WiSAT
Evaluation of the Wheelchair In-Seat Activity Tracker (WiSAT)
2 other identifiers
interventional
34
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2022
CompletedAugust 10, 2022
August 1, 2022
2.4 years
November 15, 2019
August 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
WiSAT Passive
OTHERThis arm is composed of participants who meet their activity threshold over the 4-week period.
WiSAT Active
OTHERThis arm is composed of participants who do not meet their activity threshold over the 4-week period.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Georgia Institute of Technologycollaborator
- United States Department of Defensecollaborator
Study Sites (2)
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patricia E Karg, MS
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 15, 2019
First Posted
November 19, 2019
Study Start
January 13, 2020
Primary Completion
June 17, 2022
Study Completion
June 17, 2022
Last Updated
August 10, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Any time after primary and secondary publications
- Access Criteria
- To be determined.
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.