Status:
COMPLETED
Easy Stretch Toolkit: A Pilot Study
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Facial Injuries
Eligibility:
All Genders
7-80 years
Phase:
NA
Brief Summary
To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the therapeutic management of facial burns and other facial disorders.
Detailed Description
In this initial pilot study, we plan to recruit 20 adult or pediatric patients who have sustained facial burns or who have sustained a facial injury resulting in scarring, tightness, limited range of ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 7-80
- Male or Female Sex
- Patients who have sustained a facial burn and are now in the chronic phase, or any patient experiencing facial tightness or limited range of motion due to other problems, including patients s/p radiation to the head and neck, trauma, scarring and scleroderma
- Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or limited facial expressions
- Subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent
- Subject or caregiver (parent or guardian, in case of pediatric population) must be able to perform exercises at home and must be able to record time spent using the devices.
- Participants who are undergoing other treatment methods such as use of compression garments, skin grafting, radiation or other facial surgery, etc must suspend all of these treatments for the duration of the 2 month trial.
- Internet access including access to FaceTime, Skype or Zoom and email access if electing telehealth option for enrollment
- Exclusion criteria:
- planned or unplanned surgeries for facial skin grafting around lips or nose or oral commissure release during the upcoming 8 weeks
- completion of any massaging or other stretching exercises or programs not specified by the investigators
- use of new creams or topical treatments for the duration of enrollment in the study.
- acutely burn-injured patients
- incarceration, or pregnancy
Exclusion
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03423277
Start Date
February 28 2019
End Date
November 7 2022
Last Update
November 14 2022
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555