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临床试验/NCT07780370
NCT07780370尚未招募不适用

Investigation of the Relationship Between Video-Based Objective Facial Movement Analysis and Clinical Assessment Scales in Patients With Facial Paralysis

Biruni University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
49
试验地点
1
主要终点
Agreement Between Video-Based Objective Facial Motion Analysis and Clinical Facial Assessment Scale Scores

研究概览

简要总结

This study aims to evaluate facial movements in patients with facial paralysis using video-based objective analysis and to examine the relationship between these video-based measurements and standard clinical assessment scales. Participants will be asked to perform simple facial movements, such as raising the eyebrows, closing the eyes tightly, smiling, showing the teeth, pursing the lips, and puffing the cheeks, while a video recording is taken. Researchers will also evaluate participants' facial function using established clinical rating scales and questionnaires. No medication will be given, no invasive procedures will be performed, and no changes will be made to participants' current treatment. The goal is to contribute to the development of more detailed, objective, and standardized methods for evaluating facial function in patients with facial paralysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of facial paralysis (e.g., Bell's palsy)
  • Age 18 years and older
  • Willing and able to provide informed consent

排除标准

  • Presence of other neurological or craniofacial conditions affecting facial movement
  • Prior facial surgery affecting facial musculature
  • Inability to cooperate with video recording or clinical assessment procedures

研究组 & 干预措施

Facial Paralysis Patients

Patients diagnosed with facial paralysis who underwent a single evaluation session including video-based objective facial motion analysis and clinical facial function assessment scales.

干预措施: Video-Based Objective Facial Motion Analysis (Diagnostic Test)

结局指标

主要结局

Agreement Between Video-Based Objective Facial Motion Analysis and Clinical Facial Assessment Scale Scores

时间窗: Single assessment session (Day 1)

The degree of agreement/correlation between facial movement parameters obtained from video-based objective analysis and scores obtained from standardized clinical facial assessment scales, evaluated during the same session.

Sunnybrook Facial Grading System

时间窗: Baseline

The Sunnybrook Facial Grading System (SFGS) is a clinician-rated outcome measure used to assess facial nerve function in individuals with facial paralysis. The scale evaluates three components: resting facial symmetry, voluntary facial movement, and synkinesis. Resting symmetry is assessed in the eye, cheek (nasolabial fold), and mouth regions, while voluntary movement is evaluated during five standardized facial expressions. Synkinesis is scored based on the presence and severity of involuntary associated movements during voluntary facial tasks. The composite score is calculated using the standard Sunnybrook scoring formula and ranges from 0 to 100, where 0 indicates complete facial paralysis with severe asymmetry and synkinesis, and 100 indicates normal facial function without asymmetry or synkinesis. Higher scores represent better facial nerve function.

FDI (Facial Disability Index):

时间窗: Baseline

The Facial Disability Index (FDI) is a patient-reported outcome measure used to assess the impact of facial paralysis on physical function and social well-being. The questionnaire consists of 10 items divided into two subscales: Physical Function (5 items) and Social/Well-being Function (5 items). Each subscale is transformed to a score ranging from 0 to 100, with higher scores indicating better function, less disability, and better health-related quality of life. Participants complete the questionnaire independently according to their perceived level of facial disability.

House-Brackmann Facial Grading System (HBGS)

时间窗: Baseline

The House-Brackmann Facial Grading System (HBGS), the Sunnybrook Facial Grading System (SFGS), and the Facial Disability Index (FDI) will be used to evaluate facial nerve function and patient-reported disability. HBGS is a clinician-rated six-grade scale assessing the overall severity of facial nerve dysfunction. The Sunnybrook Facial Grading System provides a composite score (0-100) based on resting symmetry, voluntary facial movements, and synkinesis, with higher scores indicating better facial function. The Facial Disability Index is a patient-reported outcome measure consisting of Physical Function and Social/Well-being subscales (0-100), where higher scores indicate less disability and better quality of life.

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Refika Belen Battal

Principal Investigator

Biruni University

研究点 (1)

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