Easy Stretch Toolkit: A Pilot Study

NCT03423277 | Completed Results DMC FDA Device

• 1 other identifier: 18-0005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Injuries

Outcome Measures

Primary Outcomes (1)

• Change in the Facial Range of Motion at Baseline and 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. Cumulative average of measurements will be reported per facial posture per participant.

  8 weeks

Secondary Outcomes (1)

• Change in the Facial Disability Index Scores From Baseline to Week 8

  baseline and week 8

Study Arms (1)

Easy Stretch Toolkit

EXPERIMENTAL

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

Interventions

Easy Stretch Toolkit DEVICE

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

Easy Stretch Toolkit

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (12)

• 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.

  PMID: 26120089 BACKGROUND

• 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.

  PMID: 27575671 BACKGROUND

• 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.

  PMID: 16413399 BACKGROUND

• 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.

  PMID: 24799851 BACKGROUND

• 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.

  PMID: 27359188 BACKGROUND

• 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.

  PMID: 23816994 BACKGROUND

• 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.

  PMID: 22508895 BACKGROUND

• 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.

  PMID: 24314374 BACKGROUND

• 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.

  PMID: 22499369 BACKGROUND

• 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.

  PMID: 29937780 BACKGROUND

• 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.

  PMID: 10823477 BACKGROUND

• 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.

  PMID: 8959998 BACKGROUND

MeSH Terms

Conditions

Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Kathleen Kerr
• Organization: University of Texas Medical Branch

kmkerr@utmb.edu

409-772-2711

Study Officials

• Lori Arguello

  employee of University of Texas Medical Branch

  PRINCIPAL INVESTIGATOR

• Kathleen Kerr

  employee of University of Texas Medical Branch

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 6, 2018
• Study Start: February 28, 2019
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)