Easy Stretch Toolkit: A Pilot Study

Facial Injuries Clinical Trial

Official title:

Easy Stretch Toolkit: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423277
• Other study ID #: 18-0005
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: November 7, 2022

Study information

• Verified date: November 2022
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 7, 2022
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Injuries

Intervention

Device:
• Easy Stretch Toolkit
Study the use of novel intraoral tools for management of facial burns and other facial disorders

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Jorge JJ Jr, Pialarissi PR, Borges GC, Squella SA, de Gouveia Mde F, Saragiotto JC Jr, Gonçalves VR. Objective computerized evaluation of normal patterns of facial muscles contraction. Braz J Otorhinolaryngol. 2012 Apr;78(2):41-51. English, Portuguese. — View 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. Review. — View 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. Review. — View 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	completed at week 1
Primary	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.	completed at week 8
Secondary	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.	completed at week 1
Secondary	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.	completed at week 8