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Interactive Telehealth for Pressure Ulcer Prevention After SCI

NCT03469141 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-13

No results posted yet for this study

Summary

The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating SCIMS centers, the investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (SENSIMAT®) that is commercially available.

Conditions

  • Spinal Cord Injuries
  • Pressure Ulcer

Interventions

DEVICE

Pressure Relief Monitoring System

Biofeedback provided to the intervention group via the smartphone app will include: Visual (e.g., phone notification bar) and auditory reminders if PR (pressure relief) is not performed as scheduled, Real-time feedback during performance of PR maneuvers to ensure adequate PR (e.g., the app will indicate if the duration of PR is sufficient), and Aggregate counts of daily PR activity.

Sponsors & Collaborators

  • Rancho Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Sara J Mulroy, PhD,PT · Rancho Los Amigos National Rehabilitation Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-10-30
Completion
2021-10-30
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 NCT03469141 on ClinicalTrials.gov