Tools for Return of Facial Function
Translating Science Into Tools for Return of Facial Function
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kathleen Kerr, MS
- 電話番号：409-772-2711
- メール：kmkerr@UTMB.EDU
研究場所
-
-
Texas
-
Galveston、Texas、アメリカ、77555
- The University of Texas Medical Branch
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
A set of three silicone intraoral splints (ball, bar, and boomerang shapes) designed to provide passive stretching of scarred or contracted orofacial tissues.
Splints are available in multiple sizes and may be used unilaterally or bilaterally to target specific areas of facial tightness and restricted movement.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Facial Landmark Excursion
時間枠：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.
|
Baseline to Week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Vertical Range of Mouth Opening (VROM)
時間枠：Baseline to Week 8
|
Change from baseline in maximum vertical mouth opening measured in millimeters using a digital caliper.
|
Baseline to Week 8
|
|
Change in Horizontal Range of Mouth Opening (HROM)
時間枠：Baseline to Week 8
|
Change from baseline in maximum horizontal mouth opening measured in millimeters using a digital caliper.
|
Baseline to Week 8
|
|
Change in Mouth Impairment and Disability Assessment (MIDA) Score
時間枠：Baseline and Week 8
|
Change from baseline in functional impairment and disability related to oral function as measured by the Mouth Impairment and Disability Assessment (MIDA).
The MIDA includes patient-reported and clinician-assessed measures of symptoms, impairment, and functional activities.
|
Baseline and Week 8
|
|
Change in CARe Burn Scale Score
時間枠：Baseline and Week 8
|
Change from baseline in burn-specific quality of life as measured by the age-appropriate CARe Burn Scale questionnaire.
|
Baseline and Week 8
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。