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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 : October 4, 2018
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, the investigators will recruit 20 adult or pediatric patients who have sustained facial burns to complete the 8 week treatment. The device creators chose 20 patients based on the investigators' experience of the available patients seen from the consult service. Participants will need to be able to attend a weekly session with the device creators and complete the entire 2 month prescriptive program. Adult participants have the option for an in person visit for weeks 1 and 8, with possibility for either in person or FaceTime or Skype calls for weeks 2-7. Pediatric participants must attend in person visits, with no option for FaceTime or Skype calls. Participants will be outpatient. For the purpose of this study, facial burns will be defined as a burn injury to the midface or lower half of the face and may be unilateral or bilateral. 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Easy Stretch Toolkit: A Pilot Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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: once per week for duration of the 8 week study ]
    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. The facial measurements are based on a calibration from pupil distance. 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 and 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.

  2. Screening of cranial nerve function for CN I [ Time Frame: completed week 1 and at week 8 ]
    function of cranial nerve I as measured by smelling an orange peel


Other Outcome Measures:
  1. Screening of cranial nerve function for CN III and IV [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve III and IV as measured by following a finger for letter "H"

  2. Screening of cranial nerve function for CN V [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve V as measured by corneal reflex test, clenching the teeth, among other actions

  3. Screening of cranial nerve function for CN VII [ Time Frame: completed at week 1 and at week 8 ]
    functional of cranial nerve VII as measured by closing the eyes, creasing the forehead, puffing out the cheeks, among other actions

  4. Screening of cranial nerve function for CN IX [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve IX as measured by presence of gag reflex

  5. Screening of cranial nerve function for CN X [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve X as measured by saying "ah"

  6. Screening of cranial nerve function for CN XI [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve XI as measured by head turn against resistance, shoulder shrug against resistance

  7. Screening of cranial nerve function for CN XII [ Time Frame: completed at week 1 and at week 8 ]
    function of cranial nerve XII as measured by sticking out the tongue



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.
  4. Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, 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, etc must suspend all of these treatments for the duration of the 2 month trial.

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 creators
  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
Contact: Speech Pathologist 409-772-2711 kmkerr@utmb.edu
Contact: Speech Pathologist 409-772-2711 lojarret@utmb.edu

Locations
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
Principal Investigator: Lori Jarrett employee of University of Texas Medical Branch
Study Director: Kathleen Kerr employee of University of Texas Medical Branch

Publications:

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03423277     History of Changes
Other Study ID Numbers: 18-0005
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries