Recruiting

TelehealthInteractive Telehealth for Pressure Ulcer Prevention After SCI

Sponsor:

Rancho Research Institute, Inc.

Code:

NCT03469141

Conditions

Spinal Cord Injuries

Pressure Ulcer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pressure Relief Monitoring System

Study Details

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 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

Study ID

NCT03469141

Start date

May 1, 2018

Status verified date

Jun, 2018

Completion date

Oct 30, 2021

Anticipated

Primary completion date

Oct 30, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Group

The control group will continue to have the WC sensor system for measurement only and will not receive biofeedback after receiving instructions on the importance of pressure relief (PR) maneuvers for skin care, as well as training regarding the three pressure relief maneuvers. Materials (including fact sheets, etc.) will be incorporated in the educational content of the project.

experimental: Intervention Group

The intervention group will receive biofeedback via the smartphone app.

Interventions

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.

Primary outcome measure

PR maneuvers per day [ Time Frame: 8 weeks ]
Sitting time [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Valerie Eberly, PT

562-385-7177 veberly@dhs.lacounty.gov

Philip S Requejo, PhD

562-385-7177 prequejo@dhs.lacounty.gov

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Phil Klebine, MA

205-934-3283 klebine@uab.edu

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

Contacts

Philip S Requejo, PhD

562-385-7177 prequejo@dhs.lacounty.gov

Valerie Eberly, PT

(562)385-7177 veberly@dhs.lacounty.gov

University of Miami

Recruiting

Miami, Florida, United States, 33136

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19102

Contacts

Mary Read, DPT

215-587-3151 mschmidt@mageerehab.org

More Information

Sponsor

Rancho Research Institute, Inc.

Last update posted

Jun 13, 2018

Last verified

Jun, 2018

Keywords

Wheelchair
Pressure Relief
Activity
Monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rancho Research Institute, Inc. on 2018-06-13.