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Easy Stretch Toolkit: A Pilot Study

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ClinicalTrials.gov Identifier: NCT03423277
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Facial Injuries Device: Easy Stretch Toolkit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Easy Stretch Toolkit: A Pilot Study
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Easy Stretch Toolkit
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




Primary Outcome Measures :
  1. UTMB Facial Range of Motion Measurement Tool [ Time Frame: completed at week 1 ]
    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.

  2. UTMB Facial Range of Motion Measurement Tool [ Time Frame: completed at 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. These will be compared over time to determine changes in facial range of motion.


Secondary Outcome Measures :
  1. Facial Disability Index [ Time Frame: completed at week 1 ]
    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.

  2. Facial Disability Index [ Time Frame: completed at week 8 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423277


Contacts
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Contact: Lori Arguello 409-772-2711 lojarret@utmb.edu
Contact: Kate Kerr 409-772-2711 kmkerr@utmb.edu

Locations
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United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Lori Jarrett    409-772-2711      
Contact: Kate Kerr    409-772-2711      
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Lori Arguello employee of University of Texas Medical Branch
Study Director: Kathleen Kerr employee of University of Texas Medical Branch
Publications:

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03423277    
Other Study ID Numbers: 18-0005
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries