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NCT04934137 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Mayo Clinic.

Completed
Registry status
NA
Development phase
46
Enrollment target

NCT04934137: Completed NA study, sponsored by Mayo Clinic.

NCT04934137 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04934137, a NA study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
NA
Development phase
46 participants
Enrollment target

Study 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 prevention of pressure injuries. 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.

Primary Outcome

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 eac

Interventions

  • BEHAVIORAL Sensoria
  • BEHAVIORAL AW-Shift

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2022-03-17
Est. Completion 2023-01-20
Phase NA
Mayo Clinic

2,844 total trials

What the finished NCT04934137 record still lists

NCT04934137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Sensoria is the first listed.

NCT04934137 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04934137 about?

NCT04934137 is a clinical study titled "Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users". 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 clini...

What is the current status of trial NCT04934137?

This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2022-03-17. Estimated completion is 2023-01-20.

What interventions are being tested in trial NCT04934137?

The interventions under investigation include: Sensoria (BEHAVIORAL), AW-Shift (BEHAVIORAL).

Who is sponsoring clinical trial NCT04934137?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04934137's enrollment target sits among peer trials

46 1402nd of 2000 higher than 590 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04934137, the US trial registry maintained by the National Library of Medicine. NCT04934137 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.