Easy Stretch Toolkit: A Pilot Study
Phase: NA
Conditions: Facial Injuries
Sponsor: The University of Texas Medical Branch, Galveston

Arguello, Lori and Kerr, Kathleen 
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Easy Stretch Toolkit: A Pilot Study 
Co-Investigators: Lori Arguello and Kathleen Kerr 
Funding Sponsor: UTMB Health Technology Commercialization Program 
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The University of Texas Medical Branch at Galveston  
 
Efficacy of the Easy Stretch Toolkit: A Pilot Study 
 
 
1. Introduction and Purpose: 
The Easy Stretch Toolkit (patent pending) is a set of three novel intraoral tools designed to deliver a 
passive stretch to scarred or contracted orofacial musculature, with the goals of: 1) increasing 
measurable range of motion for multiple facial muscles and tissues , and 2) reducing the impact and 
appearance of scar tissue.  We designed the Easy Stretch Toolkit for patients negatively impacted by 
facial burns. We propose a pilot study to test if the tools can directly target multiple sites across the 
face, with particular attention to the cheeks, nasolabial folds, upper lip, mentolabial junction and 
modiolus, achieving a stretch that currently available tools cannot provide. We hypothesize that 
there will be an expected gain of improved ability to increase use of orofacial musculature, as well as 
improved range of facial expressions and related motor functions in patients with facial burn injury.  
The Easy Stretch Toolkit is proposed for use with adults and children over the age of 7 in this pilot 
study.  Use of the device(s) is intended to be utilized by a trained Speech Pathologist.  The exact tool 
to be used will be selected by the Speech Pathologist based on the patient’s specific deficit areas and 
needs.  In this pilot study, investigation into the efficacy of the Toolkit will be limited to subjects with 
chronic facial burns, with future plans to expand the project to subjects of all ages in the acute 
healing phase if preliminary results prove the tools are effective.  Physical prototypes were created 
with the assistance of the MakerHealth Space Lab at UTMB, following the designs and initial 
prototypes of the creators (patent pending).  See Appendix A.  The current treatment options for 
patients with scars secondary to orofacial burns are discussed in the Background and pictures of tools 
are shown in Appendix B-F.  Because our tools are similar, and in some ways potentially safer than 
the current tools available in the market, we believe that the Easy Stretch Tools are a minimal risk 
device. This product represents an advance in the care of these patients. There is minimal risk 
associated with correct use of the product (discomfort from stretching, bleeding if facial burn sites 
are not fully healed, possible allergy from intraoral contact with food-grade silicone, remote choking 
risk, asymmetrical range of motion, remote tearing of the mucous membrane); the expected benefits 
are that the tools will increase mobility of the orofacial skin and musculature, as well as reduce and 
possibly prevent burn-induced scar formation. This protocol and enrollment procedures are revised 
due to the Covid -19 Pandemic to allow for increased ability to enroll participants due to the 
University’s restrictions on travel.  
 
 
2. Background: 
To date, there is not a definitive prescriptive regime for rehabilitative management of facial burns.  
Facial burns can impact oral motor function, swallowing, speech/articulation, oral hygiene and facial 
expression [1].  Some of the techniques currently utilized in management of orofacial contractures 
following burn injuries include but are not limited to: external stretching interventions, massage, 
compression garments, range of movement exercises (poorly defined in many studies), oral 
splints/mouth spreaders, lip commissuroplasties and other multiple invasive surgical procedures such 
as placement of tissue expanders, among others.  Although the literature shows some success in 
functional outcomes with the currently available treatment methodologies, there is limited data 
available to determine the specifics of a treatment plan, especially as it relates to techniques used 
and timing and frequency of the chosen techniques [2].  In their articles on burn rehabilitation, 

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Clayton and colleagues [1,2] described at least two potential orofacial and dysphagia rehabilitation 
protocols, which consisted of a combination of techniques including range of movement exercises, 
mouth splinting, use of the Orastretch and two dysphagia exercises. They reported functional gains in 
both the patients’ dysphagia and range of motion of oral musculature as measured by vertical range 
of motion and horizontal range of motion.  This data provides the beginnings of a prescriptive 
approach for management of facial burns.  
 
 
Another widely used therapeutic tool is the pressure garment [3,4].  Compression garments are used 
to decrease blood flow, nutrients and oxygen that reach the scar tissue, thereby reducing collagen 
synthesis.  It is well documented that pressure garments must be worn for at least 23 hours per day 
and for greater than 6 months to obtain the maximum benefits.  Macintyre and Baird [3] discussed 
the challenges of pressure garment use, including non-compliance with treatment and discomfort as 
a result of weather or poor fit, among other issues.  They also discussed the lack of evidence 
specifying the exact amount of pressure needed to obtain the desired result.  Similar challenges were 
documented by Atiyeh et. al., with particular attention to the difficulty in identifying and maintaining 
optimum pressure [4]. 
 
Intraoral tools that are currently available on the market for use for jaw strengthening/opening and 
tongue exercises in other patient populations were reviewed for their potential application with the 
burn population.  The Nuk brush (see Appendix B) is a cylindrical tool with a nubby textured surface 
at the end, which is used for oral sensory exploration and biting exercises.  The Beckman professional 
oral probe (see Appendix C) is another tool that is used for tongue exercises and for sensory input.   
The Chewy Tubes P’s and Q’s (Appendix D) are other tools available for biting exercises to address jaw 
strength.  The Orastretch (Appendix E) and Therabite (Appendix F) devices are applicable to the burn 
population and are designed to improve mouth and jaw opening by applying pressure to open the 
mouth in a vertical direction.  The aforementioned tools are valuable tools for tongue movement, jaw 
strength and jaw opening but do not address stretching of the facial skin and muscles or range of 
motion of the oral musculature.  The Orastretch and Therabite tools (Appendix E and F) provide 
alternatives for jaw opening but, as with the other tools mentioned above, do not directly address 
other common problem areas including restricted range of motion and scarring to the lips, cheeks, 
nasolabial folds, mentolabial junction, modiolus and forehead.  In addition to challenges with use of 
specific tools, no consistent protocol exists for active or passive ROM or stretching [5]. To reiterate, 
all of the above are considered acceptable care with varying results, but there is no single standard of 
care. 
 
In the course of our own clinical treatment for facial burn victims, many of them in both the chronic 
and acute care stages of burn rehabilitation, we have encountered significant challenges in the range 
of motion and elasticity of the facial skin and muscles in the aforementioned problem areas (vertical 
range of motion [VROM] and horizontal ROM [HROM], lips, cheeks, nasolabial folds, mentolabial 
junction, modiolus and forehead); we attempted to treat these deficits using a combination of the 
most widely known techniques, as detailed above.  Although it is was not specifically created for the 
treatment of burn patients, we used the Beckman Oral Motor Protocol but did not achieve the 
desired results, largely due to the brief nature of the stretches, the location of the stretches and poor 
carryover by caregivers in completing the required repetitions.  The patients’ managing medical team 
also utilized pressure garments, with improvement in scar appearance; however, the patients 
experienced continued oral motor deficits and severely restricted range of motion.  Based on our 

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clinical experience, we have encountered significant challenges in the treatment of these facial burn 
victims. We have tried several unconventional methods for orofacial stretching with minimal success 
and thus we developed a customized set of intraoral devices (called the Easy Stretch Toolkit) which 
we are ready to test in this pilot clinical trial.  The Toolkit would deliver a passive stretch to multiple 
sites, thereby increasing range of motion and elasticity and directly impacting both oral-facial skin 
and musculature. The design and purpose of the Easy Stretch tools differ greatly from other intraoral 
tools currently on the market (reviewed above).  The Easy Stretch tools would address multiple deficit 
areas in a new way.  Without this new treatment, patients will continue to struggle with contractures 
of the facial skin and musculature and that contractures may worsen over time.  
 
The Toolkit is not currently available to the general population and the current project will be the first 
time this product has been studied.  We, the investigators and the creators posit that the Easy Stretch 
Toolkit will be applicable for neonate, pediatric and adult burn victims.  This trial will include the adult 
and pediatric burn population. If this clinical trial is successful, our goal would be to expand to 
children under the age of 7, including the neonate population and ultimately to market, mass 
produce and sell the product to all patient populations, including patients with acute burn injuries. 
We would plan to conduct a larger trial (with a power analysis after we determine effect sizes) to 
further investigate efficacy of the Easy Stretch Toolkit. The need for early intervention in facial scar 
management was documented by Parry et. al. and Clayton et. al. [1,6].  In the future, another focus 
would be on the early use of these devices as a method for both preserving and increasing range of 
motion and elasticity in patients immediately following a burn injury.  Additional target populations 
include patients with lip contractures following cleft lip surgery, as well as research into use of the 
Toolkit as an oral stimulation device for use in the NICU population.  Use of the Easy Stretch Toolkit 
with each of these populations will need to be researched and studied by the creators; we plan to 
submit amendments to this parent protocol to include additional patient populations and indications 
in the future.  
 
3. Concise Summary of Project: 
Our proposed study and design is intended to study two Aims: 
1) To determine whether use of the devices results in measurable change in range of motion and 
quality of life via pre- and post-use data and measurements for orofacial movements and function.   
2) To develop an effective prescriptive rehabilitative plan for orofacial scar management for the 
patient to follow including an 8 week active treatment period. 
 
Experimental Device:  
The Easy Stretch Toolkit is manufactured at UTMB in the MakerHealth Space Lab. Three dimensional 
images of both the handles and heads were created in the computer 3D CAD application, Fusion 360.  
Two types of tool handles were created, the L shape and the T shape with the program Adobe 
Illustrator using the dimensions from the Fusion 360 designs.   The designs for each handle were then 
loaded into the program for a Universal Laser Cutter, which replicated the design and engraved the 
handles.  
   
Sheets of Delrin, a high-tension impervious plastic, were used to cut out the handles. Delrin was 
selected due its known FDA approval for use in the food industry and for its ability to withstand 
autoclaving.  After the handle is cut using the laser cutter machine, each handle is inspected for rough 
edges and sanded with a fine grit sandpaper as needed.    
 

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The head shapes from Fusion 360 were then used to create one and two piece 3D molds.  These 
molds were then exported to a program called Curio, which sends the images to the Ultimaker 3D 
printer.  Once printed, the molds are removed from the machine and filled.  A handle is seated in the 
mold and Sorta Clear 40 Smooth On food grade silicone is mixed per instructions in a 10:1 ratio and 
poured into the molds.  Sorta Clear 40 Smooth On was selected, as it is a known food grade silicone 
and has the ability to withstand high temperatures in autoclaving.   Once filled, the molds sit for 16 
hours to fully cure/set.   The tools are removed from the molds and any redundant silicone is 
trimmed off with scissors.  A small dot of medical grade silicone glue is then placed where the stick 
and head attach to increase security of the head on the stick.  As previously noted above, the 
material used to assist in securing the head of the tool to the stick is a medical grade epoxy that is 
FDA approved for Grade IV medical devices. Once cured, the device in its entirety had stood up to 
high level disinfecting and autoclaving. Sterilization has been confirmed with the Resi-Test along with 
the Sterigage Steam indicator. 
 
Each tool is then wiped with an enzymatic wipe and autoclaved at 260 degrees using a pass/fail 
indicator.  Each “passed” tool will be available for use in the study.  Any tool failed will be removed 
from the package, re-cleaned and re-autoclaved.  
 
Tools available for the study are then labeled on the outside of the autoclave package using a Dymo 
Label maker stating “Investigational Tool for research purposes only”. 
 
 
All tools are hand washable and will belong to the patient (will not be used between patients).  Tools 
include the circle tool (yellow), bar tool (blue), L tool (green).  See Appendix G for proposed 
placements.  
 
This study will be conducted as a single-subject design. Each patient will serve as his/her own control 
based on the purpose of the study and the large heterogeneity among patients.  Conditions which 
would result in participant exiting the study might include: non-compliance, subject withdrawal of 
consent, unexpected need for additional surgeries during the treatment period.  
 
Proposed data points (see below) were adapted from the study completed by Hadlock and Urban [7].  
In their 2012 study, they assessed resting facial distance relationships and changes in these 
relationships during movements to form different facial expressions using a novel device called Facial 
Assessment by Computer Evaluation (FACE).  The creators of the Easy Stretch Toolkit will use UTMB 
customized facial measurement software designed for this study to measure pre- and post-use 
change.  See Appendix K.  The specific measurements to be taken during selected facial movements 
are discussed below. 
 
4. Study Procedures: 
Protocol 
In this initial pilot study, we will recruit 20 adult or pediatric patients who have sustained facial burns 
or who have sustained a facial injury. A facial injury can be any disorder that results in scarring, 
tightness, limited range of motion of facial skin or musculature or fibrosis. For the purpose of this 
study, facial burn injury or facial injury will be 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 to 
complete the 8 week treatment. Chronic burns are defined as those burns that are not in the acute 

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healing phase, ie., there are no concerns for injury to new or healing skin or wound dehiscence. A 20 
subject sample size can generate meaningful estimates for the change and its variation, and within 
the range that sample size is recommended for feasibility study based the consideration in gain of 
precision for each increase of 1 in sample size [13]. Participants will need to be able to complete the 
entire 2 month prescriptive program.  All participants will need to be able to attend weekly visits via 
in person or electronic means (telehealth) such as Skype, Zoom or other electronic platform for an 
enrollment screening, followed by a total of 8 weeks of treatment.  Pediatric participants will need 
consent from a caregiver who will commit to being present for all in person or electronic visits as 
well.  Participants who are referred to the study will be contacted via phone to determine eligibility 
criteria.  If the participant meets eligibility requirements and selects telehealth option, a copy of the 
written consent form will be emailed to the participant. Verbal consent will then be obtained for 
enrollment in the study and background information will be obtained for the case history form.  A 
package will be mailed to the participant including a full set of tools, a pupil distance eye ruler, copy 
of the consent form, written subject handouts including pages for weekly documentation of use of 
the tools, and return envelopes for homework and tools. If the subject lives locally and wishes to be 
seen at a UTMB clinic or their place of residence, visits may be done in person as well. Telehealth 
option is available for all study participants, ages 7 and up. 
 
In cases of verbal consent, the investigators will request verbal confirmation by the subject/parent 
that they signed and dated the written consent form. If unable to print the 
consent/assent/permission, the subject/parent will sign and date a blank piece of paper with a 
written statement that they voluntarily agree to participate in the protocol. This statement will 
include the protocol number and name (Easy Stretch Toolkit, #18-0005). After signing and dating the 
newly created document, the study participant or legally authorized representative will send a 
photograph of the signed and dated statement or consent form by fax, text message or email to the 
investigator/designee or may return the document by mail at a later date. In all cases, informed 
consent will be obtained prior to participation in the trial.  
   
After informed consent by the subject and parent/caregiver (if applicable), each subject will complete 
an initial assessment during which the Speech Pathologist will select the appropriate tool(s) from the 
Easy Stretch Toolkit and provide training to the subject and/or caregivers in use of the device(s).  
During each visit, the Speech Pathologists will select the desired tools from the Toolkit and their 
accompanying oral placement. The recommended photographs of the 9 facial expressions will be 
taken via screen shots. Education will be provided regarding tool selection and placement location 
during each weekly visit. Participants will need to return their homework sheets and self-made 
photographs of each facial expression via email to the Speech Pathologists each week or by mail at 
the end of the study period.  
 
The tools are available in small, medium and large sizes.  The small to medium sizes for each shape 
should be the correct size for children’s mouths.  Subjects and caregivers (may be parent or guardian, 
in the case of pediatric population) will be trained until they can demonstrate independent carryover 
of the placement and verbal confirmation of the prescribed protocol.  See attachment for 
patient/caregiver education materials to be used, which will include written instructions for the 
patient (Appendix I).  Data to be gathered includes pupil distance, VROM, HROM and facial 
measurements at rest and while the subject is completing specific facial movements, with goal of 
demonstrating increased range of motion of the oral musculature and improved facial and scar 
appearance over time (Appendix H).  Initially it will be proposed that the chosen head shape be used 

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for 60 minutes (+/- 10 minutes) 2 times per day for each day of the study. Frequency of use of the 
device will be closely documented by the Speech Pathologists and the patient or caregiver using the 
provided charting system (Appendix I).  Because use of the devices will be prescriptive, the applicable 
head shape(s) and placement(s) will vary by individual and by week.  Specifically, placement(s) is (are) 
expected to vary each week based on the clinical needs of the subject and outcomes seen from the 
prior week’s intervention.  For monitoring purposes, data will be gathered at the initial assessment 
and 1 time per week thereafter (+/- 2 days) for the duration of the 8 week trial. As a result, data will 
be evaluated as to the prescriptive plan for deficits for specific facial landmarks and their associated 
muscle groups (cheeks, nasolabial folds, upper lip, mentolabial junction and modiolus). Subject safety 
will be met via an initial training session and weekly one-on-one follow-up visits via FaceTime, Skype 
or in person visit with the monitoring Speech Pathologist to assure appropriate use of the devices.  
Patient (or parent) handouts (Appendix I) will be provided to assist with recording of time spent using 
the devices and with which tool and placement location.  
 
 
Assessment of the patient after completion of informed consent 
• Photograph of the patient’s face from the front, as well as their side profile (weekly), with 
measurements taken from the photograph at specific points. At this time, profile photographs 
will not be used for measurements or analysis but will be kept to show visual changes over 
time.  
• Oral-motor facial examination will be conducted. 
 
Targeted muscle groups [8]  
The facial muscles to be targeted include: 
• Levator labii superioris – elevates the upper lip and deepens nasolabial furrow 
• Buccinator – controls movement of the cheeks and assists in sucking in neonates and 
mastication in pediatrics and adults 
• Depressor anguli oris – assists with frowning, pulls corner of mouth inferiorly 
• Mentalis – protrudes lower lip, inward and upward movement of the soft tissue of the chin 
• Zygomaticus major – pulls angle of mouth upward and laterally 
• Zygomaticus minor – raises upper lip 
• Nasalis – compresses bridge, depresses tip of nose, elevates corners of nostrils 
• Levator anguli oris – assists with smiling, elevates angle of the mouth 
• Depressor septi – depression of the nasal septum 
• Risorius – draws back the angle of the mouth laterally 
• Depressor labii inferioris – depression of the lower lip 
• Obicularis oris – sphincter around the mouth, brings lips together, retracts lower lip 
 
 
Measuring Outcomes 
The investigators will use photographs of the patient to measure multiple facial features and 
excursions during movement. Required materials include: a set of the Easy Stretch devices, 
departmental iPad with iPad stand or access to personal computer or smartphone, UTMB customized 
facial measurement software, computer, CEN-TECH 6” digital caliper.  
 

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Pictures will be taken with the patients in a seated position and head in neutral and midline position. 
Subjects will be asked to take photos with their eyes open and their face fully within the frame. A 
single blinded observer will be used to complete the measurements taken in the facial measurement 
system. 
 
Measurements to be taken:  
• Pupil distance 
• Horizontal distance between outside of nares 
• Pupil to outside of nares (right and left) 
• Pupil to outside corner of lip (right and left)  
• Superior edge of philtrum to outside corner of lip (right and left) 
• Nares to outside corner of mouth (left and right) 
• Length of philtrum 
• Superior border of upper lip to inferior border of lower lip 
• Horizontal distance between outside corners of lips 
• Inferior border of lower lip to inferior tip of chin 
 
Measurements will be taken during each of the following targeted facial expressions: 
• At rest 
• Wrinkle the nose 
• Gentle smile 
• Broad smile with lips closed 
• Broad smile with teeth together 
• Vocalizing prolonged “eee” sound 
• Vocalizing prolonged “ooo” sound 
• Lip pucker 
• Mouth opening as measured by distance between inferior upper lip and superior lower lip 
 
The customized UTMB facial software is a two dimensional measurement system. Jorge Jr., et al, 
provided a summary of several past and present measurement systems, considered as subjective vs 
objective and simple vs complex, in their article exploring measurement of peripheral facial paralysis 
[9].  Although a three dimensional measurement system such as the Vicon system [9] is beneficial for 
quantifying measurements across multiple axes especially the anteroposterior axis, the creators 
chose to pursue a two dimensional measurement system for its cost effectiveness and ease of use.  
The UTMB customized facial software is based upon use of pupil distance, as this is a static landmark 
and subsequent measurements can be graded based on this measurement.  Fields and Peckitt 
performed a similar measurement in their study, called the Facial Nerve Functional Index, measuring 
percentage change from the corner of the lip with a mouth closed position to the external corner of 
the ipsilateral eye vs smiling broadly [9].  In their 2015 article on use of their 3D dynamic quantitative 
analysis system of facial motion (3D ASFM) and assessment of mimic muscles during facial 
contraction, Feng et al proposed that the mouth-eye association and their related movements have 
the greatest influence on quality of life [10].  
 
Endpoints include degree of excursion during different facial movements.  Description of change will 
be documented in degree of difference in millimeters of movement when producing each expression 
with subsequent statistical analysis to determine that mean changes and variation of changes, and if 

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change was not the result of chance. Multiple studies have attempted to define a “normal” range of 
motion [9,11].  Specifically, although facial landmarks are consistent, it must be considered that there 
are differences in facial expressions and excursions within the same individual for both sides of the 
face, as well as between individuals of different races, ages and gender [9].  For this reason, the 
creators are unable to predict a percent change as there are currently no consistent norms for range 
of motion and excursions of facial landmarks.  Therefore, change will be evaluated within a single 
subject over completion of the course of treatment.  
 
The primary outcome will be change in degree of facial movement during different facial expressions 
as described above pre- and post-study.  The secondary outcome will be any improvements in quality 
of life pre- and post-study as captured by the Facial Disability Index.  The Facial Disability Index will be 
used as a validated quality of life instrument [12].  See Appendix M.  Although it is somewhat dated 
(1996) and it was intended for use with facial neuromuscular disorders and facial palsy, its questions 
were deemed the most relevant for this study after thorough review of available burn, facial palsy 
and general quality of life measures.  
 
The subjects will not be responsible for any research-related costs; insurance companies will not be 
billed. Validated parking will be offered if attending visits in person.  
 
 
 
5. Sub-Study Procedures: 
Not applicable.  
 
6. Criteria for Inclusion of Subjects: 
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 and are in the chronic phase of recovery to complete the 8 week treatment.   
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 
 
7. Criteria for Exclusion of Subjects: 
The following will exclude patients from participation in the study: 

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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  
 
 
9. Sources of Research Material: 
 
We are collecting clinical and demographic data from the electronic charts. We are also collecting 
data as shown in Appendix H, I, J, K, L. These will be obtained via photographs of the subject during 
different facial expressions which are uploaded into a software program for measurements to be 
taken. 
 
9. Recruitment Methods and Consenting Process: 
The investigators will request a HIPPA Waiver to identify potential subjects. Potential subjects may be 
patients or former patients of the investigators.  Additionally, they may be identified via clinic lists or 
outside referral sources. The potential subjects will be identified / referred by any clinician or 
physician and their patient(s) will be sent a recruitment letter or informational pamphlet with the 
approval of the referring clinician/physician (see Appendix L, as well as recruitment brochure).  
 
To further clarify, the investigators will pursue various methods for recruiting subjects, including 
UTMB or outside physician referrals, outside speech pathologist referrals, referrals from other 
professionals and community engagement activities.  We do not plan a multisite study, but seek the 
option to widen the scope of patient referrals by contacting other burn centers and burn support 
groups and through participation in community outreach activities.  The physicians will be asked to 
refer eligible patients; the physicians would not be engaged in the research.    Subjects will be seen at 
their place of residence or UTMB outpatient clinics or via telehealth.  Subjects may self-refer from 
marketing materials.  Outreach will include social media, such as postings to burn support group 
websites or Facebook pages, Speech Pathology special interest group pages, Facebook, UTMB 
Department of Otolaryngology Facebook page. In all recruitment scenarios, the investigators will 
notify the subject’s managing physician of their participation in the study.  If the subject cannot be 
reached by phone, a letter will mailed to the potential subject with study information. 
 
The investigators would like to request a waiver of written consent to verbally screen potential 
subjects via phone, electronic media or in person using the eligibility checklist and inclusion/exclusion 
criteria, prior to their first visit when they will sign the consent document.  Because the investigators 
are pursuing multiple recruitment avenues apart from chart review, a flexible screening process is 
necessary.  
 
At the time of the initial contact with the patient, a full description of the study will be provided.  
Consent will be obtained prior to or at the beginning of the first treatment session.  In the case of a 
pediatric subject, verbal assent will be obtained for children ages 7-12 and written assent will be 
obtained for children ages 13-17.  Parental permission will be obtained via the consent form as 
parent/guardian is now included as part of that consent form.  

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At the time of consent a detailed medical history form and written consent for participation will be 
obtained by the investigators. A copy of the consent form will be mailed to the subject. Ongoing 
participation in the study will be reviewed during the weekly visits. Subjects will be scheduled for an 
immediate start date.   
 
10. Potential Risks: 
Adverse effects are not expected. However, potential risks include possibilities for: discomfort from 
stretching, bleeding if facial burn sites are not fully healed, allergy from intraoral contact with food-
grade silicone, asymmetrical range of motion, and possible tears through the burned skin.  The 
handle is designed to reduce the risk of choking as the subject or caregiver should be holding onto 
the device when using it. However, there is a remote choking risk if the subject uses the device 
incorrectly (such as chewing on the device, sucking on the device or removing the head of the device 
from the handle).  
 
11. Subject Safety and Data Monitoring: 
The PI will review the safety of these interventions with Dr. Harold Pine, Faculty Sponsor, at 6 month 
intervals. Significant problems related to insertion of the device such as bleeding, choking will be 
reported to the IRB immediately. Any related or unrelated adverse events will be reported in a timely 
manner to the IRB. 
 
12. Procedures to Maintain Confidentiality: 
Pictures will be taken using a departmental iPad and patient data will be stored on secure UTMB 
computers.  Patient’s written or verbal consent will be obtained prior to photographing the patient.  
 
13. Potential Benefits: 
Expected benefits include: increasing range of motion for multiple facial muscles and tissues; 
reducing the impact and appearance of scar tissue; ability to target multiple sites across the face, 
with particular attention to the cheeks, nasolabial folds, upper lip, mentolabial junction and 
modiolus; achieving a stretch that currently available tools cannot provide; improved ability to 
produce different facial expressions; increased speech intelligibility; improved ability to complete oral 
hygiene.   
 
 
 
14. Biostatistics:   
Sample size calculation shows that a sample size of 20 (accounting for 10% missing rate) will be able to detect 
an effect size of 0.7 by using a two-sided paired t-test, if the real study has statistical power of 0.8 and the 
significance level (alpha) is 0.050.  
 
Descriptive statistics for continuous and categorical variables will be presented as mean ± SD and quartiles, 
and frequencies and proportions, respectively. For the weekly measurements, we will use the descriptive 
statistics and individual trend plots to present the data.  The primary outcome is the change in millimeters 
after the completion of treatment (post – pre measures) for each facial expression. We will use paired t-tests 
(if data is normally distributed) or non-parametric alternatives (e.g., Wilcoxon signed-rank test) to test if the 
changes are statistically significant. The change score of facial disability index (FDI) will be analyzed using the 
same method. The pre-post outcome of the cranial nerve assessment will be classified by categories (Pass-

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Pass, Fail-Pass, Fail-Fail), and the frequencies and proportions will be reported. Two-sided statistical 
significance will be considered for alpha at the 0.05 level for all tests. 
 
 
 
References: 
[1] Clayton NA, Ward EC, Maitz PKM. Orofacial contracture management outcomes following partial 
thickness facial burns. Burns. 2015;41(6):1291-1297.  
[2] Clayton NA, Ward EC, Maitz PK. Intensive swallowing and orofacial contracture rehabilitation after 
severe burn: A pilot study and literature review. Burns. 2017;43(1):e7-e17.  
[3] 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;32(1):10-15. 
[4] Atiyeh BS, El Khatib AM, Dibo SA. Pressure garment therapy (PGT) of burn scars: evidence-based 
efficacy. Annals of Burns and Fire Disasters. 2013;26(4):205-212. 
[5] Clayton NA, 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;38:e204-e211.  
[6] Parry I, Sen S, Palmieri T, Greenhalgh D. Nonsurgical scar management of the face: Does early 
versus late intervention affect outcome? Journal of Burn Care and Research. 2013;34(5):569-575. 
[7] Hadlock TA, Urban LS. Toward a universal, automated facial measurement tool in facial 
reanimation. Arch Facial Plast Surg. 2012;14(4):277-282. 
[8] Marur T, Tuna Y, Demirci S. Facial anatomy. Clinics in Dermatology. 2014;32(1):14-23.  
[9] Jorge Jr JJ, Pialarissi PR, Borges GC, Squella SAF, de Gouveia MdF, Saragiotto Jr JC, Goncalves VR. 
Objective computorized evaluation of normal patterns of facial muscles contraction. Braz J 
Otorhinolaryngol. 2012;78(2):41-51. 
[10] Feng G, Zhuang Y, Gao Z. Measurement and analysis of associated mimic muscle movements. 
Journal of Otology. 2015;10:39-45. 
[11] Coulson SE, Croxson GR, Gilleard WL. Quantification of the three-dimensional displacement of 
normal facial movement. Ann Otol Rhinol Laryngol. 2000;109:478-483.  
[12] VanSwearingen JM, Brach JS, Stratford PW. The facial disability index: reliability and validity of a 
disability assessment instrument for disorders of the facial neuromuscular system. Physical Therapy. 
1996;76(12):1288 
[13] Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist. 2005; 
4: 287–291. 
 
 
Appendix Legend 
 
A 
Current prototype  
B 
Nuk brush 
C 
Beckman Oral Probe 
D 
Chewy Tubes 
E 
Orastretch 
F 
Therabite 
G 
Easy Stretch Tool placements 
H 
Easy Stretch Weekly Visit Summary 
I 
Patient documentation handout 

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J 
Cranial Nerve Assessment 
K 
Example of UTMB customized facial software 
L 
Recruitment letter for patients and 
parents/guardians 
M 
Facial Disability Index 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix A 
 
Example Prototypes 
 
 
 
 
 
Appendix B – Nuk brush 
 

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Appendix C – Beckman Oral Probe 
 
 
Appendix D – Chewy Tubes 
 
 
 
 
Appendix E – Orastretch 
 
 
 
 
Appendix F - Therabite 
 
 
 
 
Appendix G  
 
Intended facial placements for the Easy Stretch Tools. Each shape has its own targeted intraoral 
placement. 
 

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Circle tool 
 
Bar tool 
 
 
 
 
 
 
 
 
 
L shape tool 
 
 
 
 

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Appendix H – see separate document for complete form with header/footer  
 
Easy Stretch Weekly Visit Summary 
 
Homework completed: yes/no 
 
Obtained copy of HW record: yes/no 
Current Tool Placement: 
 
Yellow 
#1 
#2 
#3 
Blue 
#1 
#2 
 
Green 
#1 
#2 
#3 
 
Patient Comments: 
__________________________________________________________________________________________
__________________________________________________________________________________________
___________________________________________________________________________ 
 
Patient verbalizes wish to continue in the study: yes/no 
 

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Pictures taken 
Check as completed 
At rest 
 
Wrinkle the nose 
 
Gentle smile 
 
Broad smile with lips closed 
 
Broad smile with teeth together 
 
Vocalize prolonged “eee” sound 
 
Vocalize prolonged “ooo” sound 
 
Lip pucker – drink from a straw 
 
Open mouth wide 
 
Side profile 
 
 
 
 
 
Next Tool Placement: 
 
Yellow 
#1 
#2 
#3 
Blue 
#1 
#2 
 
Green 
#1 
#2 
#3 
 
 
Follow up visit date/time: ____________________________ 
 
 
Date/Time this assessment was completed: __________________ 
 
Signature of principal and/or co-investigator: ________________________________ 
 
 
 
 
 
Appendix I 
Example patient documentation handout – see separate document for complete form with header/footer 
 
Easy Stretch Toolkit 
 
Who placed the tools? Circle one: patient/caregiver 
Tool (size and color): __________  Placement location*: _________ 
 
*See attached picture.  
 
Date 
AM – Number of minutes used PM – Number of minutes used 
 
 
 
 
 
 
 
 
 
 

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Appendix J – Cranial Nerve Assessment form - see separate document for complete form with header/footer 
 
Easy Stretch Toolkit 
Cranial Nerve Assessment: Oral Motor / Facial Measurements  
 
 
 
 
 
 
 
 
 
  
Nerve 
Task 
Comments 
Initial 
Exam 
Pass/Fail 
Final 
Exam 
Pass/Fail 
CN I Olfactory 
Smell orange peel 
 
 
 
CN III  Oculomotor 
CN IV Trochlear 
Follow the finger  
“H” 
 
 
 
CN V 
Trigeminal  
Opthalmic – brush 
across forehead 
 
 
 
 
Maxillary – cheekbone 
 
 
 
 
Mandibular- chin 
 
 
 
 

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Corneal Reflex Test 
 
 
 
 
Masseter /Temporalis– 
clench teeth 
 
 
 
 
Jaw Jerk 
 
 
 
CN VII Facial 
Crease forehead 
 
 
 
 
Close eyes 
 
 
 
 
Close eyes against 
resistance 
 
 
 
Puff out cheeks 
 
 
 
 
Smile and show teeth 
 
 
 
CN IX 
Glossopharyngeal 
Gag reflex 
 
 
 
CN X Vagus 
Say “ah” 
 
 
 
CN XI  
Accessory 
Sternocleidomastoid and 
traps –  
 
 
Head turn against 
resistance 
 
 
 
 
Shoulder shrug - 
resistance 
 
 
 
CN XII 
Hypoglossal 
Motor to muscles – 
Stick out tongue 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week #: 1 Completed on _ _ / _ _ _ / _ _ _ _Time: __________By: __________________ 
Week #: 12 Completed on _ _ / _ _ _ / _ _ _ _Time: _________By: __________________ 
 
 
 
Appendix K - Example photograph taken with customized UTMB facial software 
 
 
 

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Appendix L – Recruitment letter for patients (version for 18 years and older, as well as version for 
parents/guardians of patients under 18 years of age) 
 
 
Dear Patient, 
As a care provider, I have a responsibility to serve patients. Part of this responsibility involves 
promoting research that will help doctors understand the medical conditions that patients face. For 
this reason, I am writing to tell you about a study being conducted at UTMB by the Speech Pathology 
department. 
 
My colleagues Lori Jarrett and Kathleen Kerr, Speech Pathologists, are studying a new method of 
treatment for facial burns that have caused scarring and problems with mouth opening, difficulty 
chewing or speaking, decreased range of motion, or limited ability to produce different facial 
expressions. You suffered a facial burn injury and may be eligible to participate in this study since you 
suffered a facial burn injury. If you participate in this study, you will be asked to: Use an intraoral 
device under the guidance of the Speech Pathologist to stretch facial skin and muscles; Attend an 
initial and final in person assessment with the Speech Pathologist; Complete a FaceTime or Skype 
video call with the Speech Pathologists 1 time per week in between the in person visits; Use the 
prescribed device 2 times per day for 1 hour at a time; Keep a diary of when and how you use the 

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device(s) and email these to the Speech Pathologists; Give consent for weekly photographs of your 
face. The device(s) will be provided to you at no cost. 
 
If you are interested in learning more about the study, please contact Lori Jarrett or Kathleen Kerr at 
409-772-2711.  
 
You do not have to respond if you are not interested in this study. If you do not respond, no one will 
contact you. If you decide not to participate in the study, it will not have any effect on the quality of 
care you receive from me or any other UTMB provider.  
 
The results from this study may improve your mouth opening for better talking, chewing and oral care, 
reduce the impact and appearance of scar tissue, or improve your ability to make different facial 
expressions. 
 
Thank you for considering this research opportunity. 
 
Sincerely, 
 
 
 
Dear Parent or Guardian, 
As a care provider, I have a responsibility to serve patients. Part of this responsibility involves 
promoting research that will help doctors understand the medical conditions that patients face. For 
this reason, I am writing to tell you about a study being conducted by the UTMB Speech Pathology 
department. 
 
My colleagues Lori Jarrett and Kathleen Kerr, Speech Pathologists, are studying a new method of 
treatment for facial burns that have caused scarring and problems with mouth opening, difficulty 
chewing or speaking, decreased range of motion, or limited ability to produce different facial 
expressions. Your child suffered a facial burn injury and may be eligible to participate in this study. If 
your child participates in this study, he or she will be asked to: Use an intraoral device under the 
guidance of the Speech Pathologist to stretch facial skin and muscles; Attend weekly in person visits 
with the Speech Pathologist for 8 weeks; Use the prescribed device 2 times per day for 1 hour at a 
time; With your help, keep a diary of when and how he or she uses the device(s); Give consent for 
weekly photographs of your face. The device(s) will be provided to you at no cost. 
 
If you are interested in learning more about the study, please contact Lori Jarrett or Kathleen Kerr at 
409-772-2711.  
 
You do not have to respond if you are not interested in this study. If you do not respond, no one will 
contact you. If you decide not to participate in the study, it will not have any effect on the quality of 
care you receive from me or any other provider.  
 
The results from this study may improve your child’s mouth opening for better talking, chewing and 
oral care, reduce the impact and appearance of scar tissue, or improve your child’s ability to make 
different facial expressions. 
 
Thank you for considering this research opportunity. 
 
Sincerely, 
 
 
 
 

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Appendix M - Facial Disability Index 
 
 

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