N/A
N=8
Easy Stretch Toolkit: A Pilot Study
Facial Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03423277 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change in the Facial Range of Motion at Baseline and Week 8 — -16.12; -.08; -7.34; 4.47 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Easy Stretch Toolkit (Device)
- Age
- Pediatric, Adult, Older Adult · 7+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Facial Range of Motion at Baseline and Week 8 |
-16.12; -.08; -7.34; 4.47; -3.77; 0.53 | — |
| SECONDARY Change in the Facial Disability Index Scores From Baseline to Week 8 |
129.5; 151.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03423277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.