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Pressure Ulcer, ButtockWiSATNCT04168450

Evaluation of Wheelchair In-Seat Activity Tracker

A study testing WiSAT System, Passive Feedback and WiSAT System, Active Feedback in people with Pressure Ulcer, Buttock and Pressure Injury, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
WiSAT System, Passive Feedback and WiSAT System, Active Feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesUnited States
Study dates
13 Jan 2020to 17 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15206

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
WiSAT System, Passive Feedback, WiSAT System, Active Feedback
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WiSAT System, Passive FeedbackOther

    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.

  • WiSAT System, Active FeedbackOther

    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.

Study groups in NCT04168450
Study groupRoleWhat they receive
WiSAT PassiveOtherThis arm is composed of participants who meet their activity threshold over the 4-week period.
Receives: Other: WiSAT System, Passive Feedback
WiSAT ActiveOtherThis arm is composed of participants who do not meet their activity threshold over the 4-week period.
Receives: Other: WiSAT System, Active Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline (2 weeks) and 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start13 Jan 2020
  3. Primary completion17 Jun 2022
  4. Study completion17 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168450
Sponsor's protocol ID
STUDY19090305
Other IDs
W81XWH-17-1-0221
Acronym
WiSAT
Status last verified
Aug 2022
First submitted
15 Nov 2019
Last updated
10 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing WiSAT System, Passive Feedback and WiSAT System, Active Feedback in people with Pressure Ulcer, Buttock and Pressure Injury, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in average daily movement activity at 5 months (time frame: baseline (2 weeks) and 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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