Easy Stretch Toolkit: A Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Easy Stretch Toolkit: A Pilot Study

Conditions
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Facial Injuries

Intervention / Treatment
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* Device: Easy Stretch Toolkit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Easy Stretch Toolkit<br>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<br>* Study the use of novel intraoral tools for management of facial burns and other facial disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTMB Facial Range of Motion Measurement Tool | Facial measurements taken during select facial movements/expressions assessed by software program created at UTMB specifically for this project. The degree of change in facial movements will be assessed with 9 facial postures (face at rest, nose wrinkle, gentle smile, broad smile with lips closed, broad smile with teeth together, voice eee, voice ooo, pucker lips and open mouth wide), which will be photographed weekly. Two examples of the facial landmarks to be plotted and measured during each of the above expressions include right pupil to outside of right nare and length of philtrum, with the goal of measuring change over time with use of the Easy Stretch devices. Each of these measurements will produce a length in millimeters. These will be compared over time to determine changes in facial range of motion. | completed at week 1 | 
| UTMB Facial Range of Motion Measurement Tool | Facial measurements taken during select facial movements/expressions assessed by software program created at UTMB specifically for this project. The degree of change in facial movements will be assessed with 9 facial postures (face at rest, nose wrinkle, gentle smile, broad smile with lips closed, broad smile with teeth together, voice eee, voice ooo, pucker lips and open mouth wide), which will be photographed weekly. Two examples of the facial landmarks to be plotted and measured during each of the above expressions include right pupil to outside of right nare and length of philtrum, with the goal of measuring change over time with use of the Easy Stretch devices. Each of these measurements will produce a length in millimeters. These will be compared over time to determine changes in facial range of motion. | completed at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Disability Index | The Facial Disability Index is the name of a quality of life questionnaire which will be used for this study. It consists of 10 questions, with a scale of 0-5 for each question. 5 questions relate to physical function and 5 questions relate to social well being and function. The combined score provides an overall facial disability index score. | completed at week 1 | 
| Facial Disability Index | The Facial Disability Index is the name of a quality of life questionnaire which will be used for this study. It consists of 10 questions, with a scale of 0-5 for each question. 5 questions relate to physical function and 5 questions relate to social well being and function. The combined score provides an overall facial disability index score. | completed at week 8 |