Interactive Telehealth for Pressure Ulcer Prevention After SCI

Conditions:Skin and Soft Tissue Infections, Hospital, Orthopedic, Gastrointestinal
Therapuetic Areas:Dermatology / Plastic Surgery, Gastroenterology, Orthopedics / Podiatry, Other
Age Range:18 - 100
Start Date:May 1, 2018
End Date:October 30, 2021
Contact:Valerie Eberly, PT

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Interactive Telehealth and Auto-Biofeedback Sensor System for Pressure Ulcer Prevention After SCI

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.

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 increased
morbidity and mortality. As medical or surgical repair of established PUs is difficult and
costly, the preferred approach is prevention. Traditional prevention recommendations included
intermittent relief of interface pressure, such as performing wheelchair (WC) pushups every
30 minutes for 30 seconds or once an hour for 60 seconds. Alternatives to the push-up
maneuver, including forward and lateral trunk leans, have been recommended to reduce the
demands of weight bearing on the shoulders. One approach to address inadequate PR is to
provide a simple reminder (i.e., an alarm) at set intervals. However, this approach is
inadequate because patients who attempt PR maneuvers often do not achieve an adequate
magnitude or duration of PR for tissue unloading. In addition, compliance with PR performance
can be negatively impacted by unanticipated life circumstances. A system to measure PR
maneuvers in the home and community and provide reminders and feedback on frequency and
success of individual attempts of this important preventative activity could reduce the
incidence of PUs. In this collaborative project, the investigators will establish the
efficacy of a sensor and feedback technology system for promoting effective pressure relief
behaviors and reducing risk of pressure ulcer development among wheelchair users. 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 (sensor and
smartphone app) that is developed and validated. The fully functional system is unobtrusive
and simple. The system attaches to any WC (without modification) and generates automatic
reminders via an app. Biofeedback, also delivered via the app, indicates in real time when a
PR maneuver has been completed successfully. The display also tracks the user's daily PR
activity as the participants works towards a daily goal.

Specific Aims:

Primary: Compare PR behavior (daily PR frequency and average duration of uninterrupted
sitting) between participants who receive education and four weeks of biofeedback training
with the monitoring system (intervention group) and those who receive education but no system
feedback (control group). Secondary: Compare the incidence of ischial PU development at one
year post-intervention between groups.


1) Biofeedback from the monitoring system will increase PR frequency and decrease
uninterrupted sitting time compared to that achieved by education and goal setting without
feedback. 2) Improvements in PR adherence will be retained after two weeks of wash-out (no
feedback). 1) Incidence of ischial PU development will be lower in participants who receive
feedback training with the telehealth monitoring system than in the control group. Methods:
Participants will be at least 18 years of age, between 2 and 6 months post SCI, full-time WC
users for community mobility (AIS A-C), able to perform PR maneuvers without assistance, and
have no current or prior history of a PU. A total of one hundred (n=100) manual WC users from
all collaborating centers will participate in an 8-week monitoring trial with a one-year
follow-up to assess PU development. All participants will complete two weeks of recording PR
behavior by the monitoring system without feedback. Following baseline assessment,
participants will be randomized into one of two groups: an intervention group that will
receive an education session on PU prevention with goal setting for PR frequency and duration
followed by four weeks of biofeedback via the smartphone app component of the monitoring
system, or a control group that will receive only the education and goal setting session, but
will not receive biofeedback and will have the WC sensor system for measurement only. After
four weeks, the biofeedback feature in the intervention group will be turned off. The system
will continue to monitor activities for another two weeks. The investigators will assess
whether improvements in PR adherence are retained after the 4-week bout of biofeedback
(washout). Participants will return one year following the 8-week intervention to assess
whether they have developed a PU. Participants will be queried and their medical record
reviewed regarding PU occurrence since the intervention. A physician, nurse, or other
clinician will examine participants' skin visually and record presence of any PUs (stages
1-4) in the ischial region.

Proposed Outcomes:

To establish the efficacy of the wheelchair seat sensor and app-based biofeedback for
establishing healthy self-management behaviors (pressure relief maneuvers) and reducing
incidence of pressure ulcer development in individuals with recent SCI.

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.
We found this trial at
Birmingham, Alabama 35294
Phone: 205-934-3283
Birmingham, AL
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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Downey, California 90242
Phone: 562-385-7177
Downey, CA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-587-3151
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Philadelphia, PA
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