CMAP Refinement for Pressure Injury Prevention

NCT04309864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-28

No results posted yet for this study

Summary

For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being. Pressure injuries are costly to treat, negatively impact quality of life and community participation, and can be life threatening. Moving or shifting at regular intervals in the wheelchair redistributes harmful pressure and reduces risk for skin breakdown, yet these movements are a challenge to perform consistently. The challenge exists due to lack of sensation to let the individual know they need to shift their weight. Pressure mapping provides a detailed visual representation of pressure distribution and can compensate for impaired sensation. Pressure mapping feedback delivered on-demand on mobile platforms can potentially increase effectiveness in carrying out behaviors to reduce risk for pressure injury when used during clinician-delivered education to set goals and monitor progress and when used at home as a self-management strategy.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Use of CMAP app for education (in-hospital)

Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.

DEVICE

Use of CMAP app (in-home)

The Veteran will use the CMAP system at home for two weeks during their daily routines.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Byron W Eddy · Minneapolis VA Health Care System, Minneapolis, MN

  • Christine M. Olney, BSN MS PhD · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309864 on ClinicalTrials.gov