Interactive Telehealth for Pressure Ulcer Prevention After SCI
Status unconfirmed · Not applicable
Conditions studied: Spinal Cord Injuries, Pressure Ulcer
In brief
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.
Key facts
- Study ID
- NCT03469141
- Run by
- Rancho Research Institute, Inc.
- People needed
- 100
- Starts
- 2018-05-01
- Expected to finish
- 2021-10-30
- Last updated by the study team
- 2018-06-13
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Persons with documented SCI, American Spinal Injury Association Impairment Scale (AIS) A, B, or C.
- Persons who are full time manual wheelchair users.
- persons over the age of 18.
- 2-6 months post-injury.
- Able to perform pressure relief maneuvers without assistance
- Cognitively able to understand and sign informed consent form approved by the IRB
- Free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study
You may not qualify if…
- History of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function, preventing them from performing pressure ulcer relief maneuvers or propelling a wheelchair.
- history of ischial pressure ulcer.
Where it is running
- University of Alabama — Birmingham, Alabama, United States (enrolling)
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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