Status:
UNKNOWN
Interactive Telehealth for Pressure Ulcer Prevention After SCI
Lead Sponsor:
Rancho Research Institute, Inc.
Conditions:
Spinal Cord Injuries
Pressure Ulcer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 pre...
Detailed Description
Overview and Rationale: Pressure ulcers (PUs) are a frequent and serious secondary complication after SCI with an annual incidence of 31% and a lifetime incidence of up to 85%. PUs are linked to incr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03469141
Start Date
May 1 2018
End Date
October 30 2021
Last Update
June 13 2018
Active Locations (4)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
3
University of Miami
Miami, Florida, United States, 33136
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19102