NCT03423277

Easy Stretch Toolkit: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 7 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Facial Injuries

Interventions

Type	Name	Description
DEVICE	Easy Stretch Toolkit	Study the use of novel intraoral tools for management of facial burns and other facial disorders

Timeline

• Start date: 2019-02-28
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2018-02-06
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study