An interventional study of Easy Stretch Toolkit in Facial Injuries, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged 7 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Facial Injuries; 5 are open to participants now.
This study's enrollment of 8 is below the median of 15 across 13 interventional studies indexed under Facial Injuries.
Browse Facial Injuries studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Change in the Facial Range of Motion at Baseline and Week 8
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. Cumulative average of measurements will be reported per facial posture per participant.
Time frame: 8 weeks
Change in the Facial Disability Index Scores From Baseline to Week 8
The Facial Disability Index (FDI) is a validated quality-of-life questionnaire consisting of 10 items, each scored on a 0-5 scale. Five items assess physical function and five items assess social well-being and function. Raw subscale scores are transformed according to standard FDI scoring procedures to yield physical function scores ranging from 0 to 100 and social function scores ranging from 0 to 100. The total Facial Disability Index score is calculated by summing the transformed physical and social subscale scores, resulting in a total score range of 0 to 200. Higher scores indicate better facial function and quality of life, while lower scores indicate greater facial disability.
Time frame: baseline and week 8
| Milestone | Easy Stretch Toolkit |
|---|---|
| Started | 8 |
| Completed | 4 |
| Not completed | 4 |
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. Cumulative average of measurements will be reported per facial posture per participant.
| mm | Facial Measurement Data |
|---|---|
| At Rest | -16.12 (-20.56 to 7.99) |
| Wrinkle Nose | -.08 (-16.77 to 6.43) |
| Gentle Smile | -7.34 (-18.78 to 3.02) |
| Broad Smile Lips Closed | 4.47 (-10.89 to 16.47) |
| Broad Smile Show Teeth | -3.77 (-13.55 to 11.30) |
| Say 'ooo' | 0.53 (-11.24 to 12.03) |
| Say 'eee' | -1.86 (-6.68 to 12.173) |
| Pucker | -2.97 (-12.66 to 14.84) |
| Open Your Mouth Wide | 0.14 (-13.95 to 8.57) |
The Facial Disability Index (FDI) is a validated quality-of-life questionnaire consisting of 10 items, each scored on a 0-5 scale. Five items assess physical function and five items assess social well-being and function. Raw subscale scores are transformed according to standard FDI scoring procedures to yield physical function scores ranging from 0 to 100 and social function scores ranging from 0 to 100. The total Facial Disability Index score is calculated by summing the transformed physical and social subscale scores, resulting in a total score range of 0 to 200. Higher scores indicate better facial function and quality of life, while lower scores indicate greater facial disability.
| score on a scale | Facial Disability Index Score |
|---|---|
| baseline | 129.5 (78 to 170) |
| 8 weeks | 151.5 (105 to 183) |
Collected over 8 weeks for each participant or the duration that they were enrolled in the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Easy Stretch Toolkit | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Easy Stretch Toolkit |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Easy Stretch Toolkit |
|---|---|
| Female | 2 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Easy Stretch Toolkit |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Easy Stretch Toolkit |
|---|---|
| United States | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Nov 2022, 44 months.
Results were first posted in Feb 2026, 3 years 3 months after primary completion.
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