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Easy Stretch Toolkit: A Pilot Study

Primary Purpose

Facial Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Easy Stretch Toolkit
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Injuries

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Easy Stretch Toolkit

Arm Description

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.

Outcomes

Primary Outcome Measures

UTMB Facial Range of Motion Measurement Tool
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.
UTMB Facial Range of Motion Measurement Tool
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

Facial Disability Index
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.
Facial Disability Index
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.

Full Information

First Posted
January 16, 2018
Last Updated
November 10, 2022
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03423277
Brief Title
Easy Stretch Toolkit: A Pilot Study
Official Title
Easy Stretch Toolkit: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Easy Stretch Toolkit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Easy Stretch Toolkit
Intervention Description
Study the use of novel intraoral tools for management of facial burns and other facial disorders
Primary Outcome Measure Information:
Title
UTMB Facial Range of Motion Measurement Tool
Description
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.
Time Frame
completed at week 1
Title
UTMB Facial Range of Motion Measurement Tool
Description
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.
Time Frame
completed at week 8
Secondary Outcome Measure Information:
Title
Facial Disability Index
Description
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.
Time Frame
completed at week 1
Title
Facial Disability Index
Description
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.
Time Frame
completed at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Arguello
Organizational Affiliation
employee of University of Texas Medical Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Kerr
Organizational Affiliation
employee of University of Texas Medical Branch
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26120089
Citation
Clayton NA, Ward EC, Maitz PK. Orofacial contracture management outcomes following partial thickness facial burns. Burns. 2015 Sep;41(6):1291-7. doi: 10.1016/j.burns.2015.02.015. Epub 2015 Jun 26.
Results Reference
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PubMed Identifier
27575671
Citation
Clayton NA, Ward EC, Maitz PK. Intensive swallowing and orofacial contracture rehabilitation after severe burn: A pilot study and literature review. Burns. 2017 Feb;43(1):e7-e17. doi: 10.1016/j.burns.2016.07.006. Epub 2016 Aug 26.
Results Reference
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PubMed Identifier
16413399
Citation
Macintyre L, Baird M. Pressure garments for use in the treatment of hypertrophic scars--a review of the problems associated with their use. Burns. 2006 Feb;32(1):10-5. doi: 10.1016/j.burns.2004.06.018.
Results Reference
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PubMed Identifier
24799851
Citation
Atiyeh BS, El Khatib AM, Dibo SA. Pressure garment therapy (PGT) of burn scars: evidence-based efficacy. Ann Burns Fire Disasters. 2013 Dec 31;26(4):205-12.
Results Reference
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PubMed Identifier
27359188
Citation
Clayton NA, Ellul G, Ward EC, Scott A, Maitz PK. Orofacial Contracture Management: Current Patterns of Clinical Practice in Australian and New Zealand Adult Burn Units. J Burn Care Res. 2017 Jan/Feb;38(1):e204-e211. doi: 10.1097/BCR.0000000000000351.
Results Reference
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PubMed Identifier
23816994
Citation
Parry I, Sen S, Palmieri T, Greenhalgh D. Nonsurgical scar management of the face: does early versus late intervention affect outcome? J Burn Care Res. 2013 Sep-Oct;34(5):569-75. doi: 10.1097/BCR.0b013e318278906d.
Results Reference
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PubMed Identifier
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Citation
Hadlock TA, Urban LS. Toward a universal, automated facial measurement tool in facial reanimation. Arch Facial Plast Surg. 2012 Jul-Aug;14(4):277-82. doi: 10.1001/archfacial.2012.111.
Results Reference
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PubMed Identifier
24314374
Citation
Marur T, Tuna Y, Demirci S. Facial anatomy. Clin Dermatol. 2014 Jan-Feb;32(1):14-23. doi: 10.1016/j.clindermatol.2013.05.022.
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PubMed Identifier
22499369
Citation
Jorge JJ Jr, Pialarissi PR, Borges GC, Squella SA, de Gouveia Mde F, Saragiotto JC Jr, Goncalves VR. Objective computerized evaluation of normal patterns of facial muscles contraction. Braz J Otorhinolaryngol. 2012 Apr;78(2):41-51. doi: 10.1590/S1808-86942012000200008.
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PubMed Identifier
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Citation
Feng G, Zhuang Y, Gao Z. Measurement and analysis of associated mimic muscle movements. J Otol. 2015 Mar;10(1):39-45. doi: 10.1016/j.joto.2015.06.001. Epub 2015 Aug 1.
Results Reference
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Citation
Coulson SE, Croxson GR, Gilleard WL. Quantification of the three-dimensional displacement of normal facial movement. Ann Otol Rhinol Laryngol. 2000 May;109(5):478-83. doi: 10.1177/000348940010900507.
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VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300. doi: 10.1093/ptj/76.12.1288.
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Easy Stretch Toolkit: A Pilot Study

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