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Clinical Trials/NCT04168450
NCT04168450CompletedNot Applicable

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

University of Pittsburgh2 sites in 1 country34 target enrollmentStarted: January 13, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
Change from baseline in average daily movement activity at 5 months

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

WiSAT Passive

Other

This arm is composed of participants who meet their activity threshold over the 4-week period.

Intervention: WiSAT System, Passive Feedback (Other)

WiSAT Active

Other

This arm is composed of participants who do not meet their activity threshold over the 4-week period.

Intervention: WiSAT System, Active Feedback (Other)

Outcomes

Primary Outcomes

Change from baseline in average daily movement activity at 5 months

Time Frame: baseline (2 weeks) and 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patricia Karg

Associate Professor

University of Pittsburgh

Study Sites (2)

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