Pressure UlcerNCT04934137

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

A study testing Sensoria and AW-Shift in people with Pressure Ulcer and Pressure Injury, run by Mayo Clinic at 4 sites in United States.

Completed

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

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pressure Ulcer, Pressure Injury, Wheelchair
What is being tested?: Sensoria and AW-Shift
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 4 sitesUnited States
Study dates: 17 Mar 2022to 20 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Georgia Institute of Technology
Atlanta, Georgia, 30332
University of Texas Medical Branch
Galveston, Texas, 77555
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the 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.

Conditions: Pressure Ulcer, Pressure Injury, Wheelchair
Being tested: Sensoria, AW-Shift
Keywords: Pressure Injury, Pressure Ulcer, Weight Shift, Wheelchair, Pressure monitoring, Pressure relief
Medical subject headings: Pressure Ulcer

What participants receive

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

SensoriaBehavioural
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.
AW-ShiftBehavioural
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.

Study groups in NCT04934137
Study group	Role	What they receive
Sensoria first intervention	Active comparator	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. Receives: Behavioral: Sensoria; Behavioral: AW-Shift
AW-Shift first intervention	Active comparator	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. Receives: Behavioral: Sensoria; Behavioral: AW-Shift

What is being measured

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

Normalized Weight Shift Frequency (Weight Shifts/Hour)
The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase.
Measured: The outcome measure was assessed at week 4 (the end) of each intervention period.

Timeline

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

17 Mar 202220 Jan 2023

First posted22 Jun 2021
Study start17 Mar 2022
Primary completion20 Jan 2023
Study completion20 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pressure UlcerStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Crossover
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04934137
Sponsor's protocol ID: 19-008916
Other IDs: R01AG056255
Status last verified: Jan 2024
First submitted: 14 Jun 2021
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury

All Pressure Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users
ClinicalTrials.gov ID: NCT04934137
Acronym / sponsor ID: 19-008916
Conditions: Pressure Ulcer, Pressure Injury, Wheelchair
Keywords: Pressure Injury, Pressure Ulcer, Weight Shift, Wheelchair, Pressure monitoring, Pressure relief
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), University of Minnesota, Georgia Institute of Technology
Study start: 17 Mar 2022 (actual)
Primary completion: 20 Jan 2023 (actual)
Study completion: 20 Jan 2023 (actual)
First posted: 22 Jun 2021 (actual)
Results: Posted 20 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sensoria first intervention	Active comparator	Behavioral: Sensoria, Behavioral: AW-ShiftGroup 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.
AW-Shift first intervention	Active comparator	Behavioral: Sensoria, Behavioral: AW-ShiftGroup 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SensoriaThe 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.	Behavioural	AW-Shift first intervention, Sensoria first intervention
AW-ShiftThe 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.	Behavioural	AW-Shift first intervention, Sensoria first intervention

Primary outcome

Normalized Weight Shift Frequency (Weight Shifts/Hour)
Time frame: The outcome measure was assessed at week 4 (the end) of each intervention period.
The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase.

Results and safety

Results posted to the registry on 20 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sensoria First Intervention	23	21
AW-Shift First Intervention	23	20

Primary outcome: Normalized Weight Shift Frequency (Weight Shifts/Hour)

Time frame: The outcome measure was assessed at week 4 (the end) of each intervention period.. Mean (Standard Deviation). Unit: normalized weight shifts per hour

Measure	Participants Who Completed Sensoria Intervention n = 27	Participants Who Completed AW-Shift Intervention n = 18
Value	2.41 (1.93)	2.38 (2.03)

Population analysed: Analysis population for each arm includes participants who had usable data who completed that intervention, regardless of which was completed first. Some participants completed both interventions and will be included in both "arms". Some participants were not appropriate for both interventions and only completed 1, but were still included in analysis because they had usable data and completed at least 1 intervention period.

Adverse events

Time frame: Adverse events were collected before and after each intervention phase at approximately 2, 6, and 12 weeks after the start of the baseline phase of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sensoria First Intervention	0 of 18 (0%)	0 of 18 (0%)	0 of 18
AW-Shift First Intervention	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Pressure Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Hallbeck, PhD principal investigator

Mayo Clinic

Tamara Vos-Draper, PhD, OT principal investigator

University of Minnesota

Sharon Sonenblum, PhD principal investigator

Georgia Institute of Technology

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sensoria and AW-Shift in people with Pressure Ulcer and Pressure Injury, run by Mayo Clinic at 4 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 6 inclusion and 7 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Normalized Weight Shift Frequency (Weight Shifts/Hour) (time frame: The outcome measure was assessed at week 4 (the end) of each intervention period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04934137.

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 20 Feb 2024.