Clinical trial NCT03423277: Easy Stretch Toolkit: A Pilot Study
Official title: Easy Stretch Toolkit: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Injuries
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 motion of facial skin or musculature, or fibrosis to complete the 8 week treatment. Participants will need to be able to attend a weekly telehealth or in person session with the investigators and complete the entire 8 week prescriptive program. Participants will be outpatient. A facial injury can be any disorder that results in scarring, tightness, limited range of motion of facial skin or musculature or fibrosis. Facial burn injury or facial injury is defined as an injury to the midface or lower half of the face and may be unilateral or bilateral. Participants must be in the chronic phase of recovery. 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.

Eligibility criteria: 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, 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
4. Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or 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, radiation or other facial surgery, etc must suspend all of these treatments for the duration of the 2 month trial.
8. Internet access including access to FaceTime, Skype or Zoom and email access if electing telehealth option for enrollment

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 investigators
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

Primary outcomes:
measure: UTMB Facial Range of Motion Measurement Tool
timeFrame: completed at week 1
measure: UTMB Facial Range of Motion Measurement Tool
timeFrame: completed at week 8
Secondary outcomes:
measure: Facial Disability Index
timeFrame: completed at week 1
measure: Facial Disability Index
timeFrame: completed at week 8
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: employee of University of Texas Medical Branch
name: Lori Arguello
role: PRINCIPAL_INVESTIGATOR
affiliation: employee of University of Texas Medical Branch
name: Kathleen Kerr
role: STUDY_DIRECTOR
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