Easy Stretch Toolkit: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03423277

Enrollment

Registered

2018-02-06

Start date

2019-02-28

Completion date

2022-11-07

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Injuries

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.

Interventions

DEVICEEasy Stretch Toolkit

Study the use of novel intraoral tools for management of facial burns and other facial disorders

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in the Facial Range of Motion at Baseline and Week 8	8 weeks	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.

Secondary

Measure	Time frame	Description
Change in the Facial Disability Index Scores From Baseline to Week 8	baseline and 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLori Arguello

employee of University of Texas Medical Branch

STUDY_DIRECTORKathleen Kerr