Easy Stretch Toolkit: A Pilot Study
Easy Stretch Toolkit: A Pilot Study
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.
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.
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