Translating Science Into Tools for Return of Facial Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Facial Landmark Excursion
研究概览
简要总结
This study will evaluate novel intraoral (inside-the-mouth) splints designed to gently stretch facial tissues that have become tight or scarred following facial trauma, including burn injuries and gunshot wounds. Scar contractures can limit mouth opening, facial movement, and facial expressions, affecting daily function and quality of life.
Participants aged 7 years and older with facial contractures will be fitted with one or more silicone splints selected by a trained speech-language pathologist based on each participant's areas of restriction. The splints are available in different shapes and sizes and are designed to provide passive stretching to targeted areas of the face and mouth.
Researchers will assess changes in facial mobility, mouth opening, facial symmetry, and range of facial expression using clinical measurements and facial movement analysis software. The study will also help identify appropriate treatment protocols for use of the splints.
The researchers expect that use of the splints may improve facial movement and function, reduce the effects of scar contractures, and potentially decrease the need for future surgical procedures to improve facial mobility. Findings from this study may support a new treatment option for individuals with facial scarring due to burns or other traumatic injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7-100
- •Male or Female Sex
- •Patients who have sustained facial trauma, facial injury or a facial burn and are now in the chronic phase
- •Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or limited facial expressions
- •Subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent
- •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 splints
- •Participants who are undergoing other treatment methods such as facial surgeries, use of compression garments, skin grafting, etc., must suspend all these treatments for the duration of the 8-week trial
- •Access to internet and smartphone or computer capable of taking screenshots and with adequate audio and video capabilities (for those opting to participate via telehealth sessions
排除标准
- •Planned or unplanned surgeries for facial skin grafting around lips or nose, or oral commissure release during the 8-week trial
- •Completion of any massaging or other stretching exercises or programs not specified by the investigators
- •Use of new creams or topical treatments for the duration of enrollment in the study
- •Acutely burn-injured patients
- •Incarceration or pregnancy
- •History of neurological deficit
研究组 & 干预措施
Intraoral Splint Therapy
Participants with facial burns or other facial trauma resulting in orofacial contractures, scarring, fibrosis, or limited facial movement will receive individualized treatment using intraoral stretching splints. A trained speech-language pathologist will select the appropriate splint shape, size, and placement based on each participant's areas of facial restriction. Participants will use the prescribed splint or splints twice daily for approximately 60 minutes per session over an 8-week treatment period, with weekly assessments and adjustment of the treatment plan as needed.
干预措施: Intraoral Stretching Splints (Device)
结局指标
主要结局
Change in Facial Landmark Excursion
时间窗: Baseline to Week 8
Change from baseline in excursion (millimeters) between predefined facial landmarks during standardized facial expressions (rest, nose wrinkle, broad smile, lip pucker, and maximum mouth opening), measured using customized facial measurement software.
次要结局
- Change in Vertical Range of Mouth Opening (VROM)(Baseline to Week 8)
- Change in Horizontal Range of Mouth Opening (HROM)(Baseline to Week 8)
- Change in Mouth Impairment and Disability Assessment (MIDA) Score(Baseline and Week 8)
- Change in CARe Burn Scale Score(Baseline and Week 8)