Trial Outcomes & Findings for Easy Stretch Toolkit: A Pilot Study (NCT NCT03423277)

Last Updated: 2026-02-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	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. Easy Stretch Toolkit: Study the use of novel intraoral tools for management of facial burns and other facial disorders
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Easy Stretch Toolkit: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Easy Stretch Toolkit n=8 Participants 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. Easy Stretch Toolkit: Study the use of novel intraoral tools for management of facial burns and other facial disorders
Age, Categorical <=18 years	2 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Sex: Female, Male Female	2 Participants n=41 Participants
Sex: Female, Male Male	6 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	2 Participants n=41 Participants
Race (NIH/OMB) White	6 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	8 participants n=41 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 8 enrolled, only 4 completed program

Outcome measures

Outcome measures
Measure	Facial Measurement Data n=4 Participants Facial measurement data were collected at week 1 and week 8 for each participant as distance between 2 facial landmarks as the participant completed requested facial expressions such as "open mouth wide" and "gentle smile". Data was collected for 13 measurements across 9 facial expressions.
Change in the Facial Range of Motion at Baseline and Week 8 At Rest	-16.12 mm Interval -20.56 to 7.99
Change in the Facial Range of Motion at Baseline and Week 8 Wrinkle Nose	-.08 mm Interval -16.77 to 6.43
Change in the Facial Range of Motion at Baseline and Week 8 Gentle Smile	-7.34 mm Interval -18.78 to 3.02
Change in the Facial Range of Motion at Baseline and Week 8 Broad Smile Lips Closed	4.47 mm Interval -10.89 to 16.47
Change in the Facial Range of Motion at Baseline and Week 8 Broad Smile Show Teeth	-3.77 mm Interval -13.55 to 11.3
Change in the Facial Range of Motion at Baseline and Week 8 Say 'ooo'	0.53 mm Interval -11.24 to 12.03
Change in the Facial Range of Motion at Baseline and Week 8 Say 'eee'	-1.86 mm Interval -6.68 to 12.173
Change in the Facial Range of Motion at Baseline and Week 8 Pucker	-2.97 mm Interval -12.66 to 14.84
Change in the Facial Range of Motion at Baseline and Week 8 Open Your Mouth Wide	0.14 mm Interval -13.95 to 8.57

SECONDARY outcome

Timeframe: baseline and week 8

The Facial Disability Index (FDI) is a validated quality-of-life questionnaire consisting of 10 items, each scored on a 0-5 scale. Five items assess physical function and five items assess social well-being and function. Raw subscale scores are transformed according to standard FDI scoring procedures to yield physical function scores ranging from 0 to 100 and social function scores ranging from 0 to 100. The total Facial Disability Index score is calculated by summing the transformed physical and social subscale scores, resulting in a total score range of 0 to 200. Higher scores indicate better facial function and quality of life, while lower scores indicate greater facial disability.

Outcome measures

Outcome measures
Measure	Facial Measurement Data n=4 Participants Facial measurement data were collected at week 1 and week 8 for each participant as distance between 2 facial landmarks as the participant completed requested facial expressions such as "open mouth wide" and "gentle smile". Data was collected for 13 measurements across 9 facial expressions.
Change in the Facial Disability Index Scores From Baseline to Week 8 baseline	129.5 score on a scale Interval 78.0 to 170.0
Change in the Facial Disability Index Scores From Baseline to Week 8 8 weeks	151.5 score on a scale Interval 105.0 to 183.0

Adverse Events

Easy Stretch Toolkit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Kerr

University of Texas Medical Branch

Phone: 409-772-2711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place