Easy Stretch Toolkit: A Pilot Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 7 - 80 |
| Updated: | 3/6/2019 |
| Start Date: | February 28, 2019 |
| End Date: | November 2019 |
| Contact: | Lori Jarrett |
| Email: | lojarret@utmb.edu |
| Phone: | 409-772-2711 |
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.
therapeutic management of facial burns and other facial disorders.
In this initial pilot study, the investigators will recruit 20 adult or pediatric patients
who have sustained facial burns to complete the 8 week treatment. The device creators chose
20 patients based on the investigators' experience of the available patients seen from the
consult service. Participants will need to be able to attend a weekly session with the device
creators and complete the entire 2 month prescriptive program. Adult participants have the
option for an in person visit for weeks 1 and 8, with possibility for either in person or
FaceTime or Skype calls for weeks 2-7. Pediatric participants must attend in person visits,
with no option for FaceTime or Skype calls. Participants will be outpatient. For the purpose
of this study, facial burns will be defined as a burn injury to the midface or lower half of
the face and may be unilateral or bilateral. 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.
who have sustained facial burns to complete the 8 week treatment. The device creators chose
20 patients based on the investigators' experience of the available patients seen from the
consult service. Participants will need to be able to attend a weekly session with the device
creators and complete the entire 2 month prescriptive program. Adult participants have the
option for an in person visit for weeks 1 and 8, with possibility for either in person or
FaceTime or Skype calls for weeks 2-7. Pediatric participants must attend in person visits,
with no option for FaceTime or Skype calls. Participants will be outpatient. For the purpose
of this study, facial burns will be defined as a burn injury to the midface or lower half of
the face and may be unilateral or bilateral. 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.
4. Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased
range of motion for oral structures, 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, etc must suspend all of these treatments for the duration of
the 2 month trial.
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 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
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: 409-772-2711
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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