Purpose

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.

Condition

Eligibility

Eligible Ages
Between 7 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age 7-80
  2. Male or Female Sex
  3. Patients who have sustained a facial burn and are now in the chronic phase.
  4. Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, limited facial expressions
  5. Subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent
  6. 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.
  7. Participants who are undergoing other treatment methods such as use of compression garments, skin grafting, etc must suspend all of these treatments for the duration of the 2 month trial.

Exclusion Criteria

  1. planned or unplanned surgeries for facial skin grafting around lips or nose or oral commissure release during the upcoming 8 weeks
  2. completion of any massaging or other stretching exercises or programs not specified by the creators
  3. use of new creams or topical treatments for the duration of enrollment in the study.
  4. acutely burn-injured patients
  5. incarceration, or pregnancy

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Easy Stretch Toolkit
All participants will be using one or more of devices for 60 minutes 2 times per day for the duration of the 8 week trial. Prescriptive instructions for specific intraoral placements will be given based on the participant's deficit areas.
  • Device: Easy Stretch Toolkit
    Study the use of novel intraoral tools for management of facial burns and other facial disorders

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Lori Jarrett
409-772-2711

More Details

NCT ID
NCT03423277
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Lori Jarrett
409-772-2711
lojarret@utmb.edu

Detailed Description

In this initial pilot study, the investigators will recruit 20 adult or pediatric patients who have sustained facial burns to complete the 8 week treatment. The device creators chose 20 patients based on the investigators' experience of the available patients seen from the consult service. Participants will need to be able to attend a weekly session with the device creators and complete the entire 2 month prescriptive program. Adult participants have the option for an in person visit for weeks 1 and 8, with possibility for either in person or FaceTime or Skype calls for weeks 2-7. Pediatric participants must attend in person visits, with no option for FaceTime or Skype calls. Participants will be outpatient. For the purpose of this study, facial burns will be defined as a burn injury to the midface or lower half of the face and may be unilateral or bilateral. Chronic burns are defined as those burns that are not in the acute healing phase, ie., there are no concerns for injury to new or healing skin or wound dehiscence.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.