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临床试验/NCT07573358
NCT07573358尚未招募不适用

Validation of Artificial Intelligence-Based Facial Paralysis Assessment in Patients With Bell's Palsy

Cairo University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
63
试验地点
1

研究概览

简要总结

This observational study aims to assess the concurrent validity of an artificial intelligence (AI)-based facial paralysis assessment system in patients with unilateral Bell's palsy. Currently, clinical assessment relies on subjective scales like the Sunnybrook Facial Grading System, which can vary between different observers. This study will compare AI-generated composite asymmetry scores-derived from real-time computer vision analysis of facial landmarks-with scores from the Sunnybrook system. The goal is to determine if AI can provide a valid, objective method for monitoring facial nerve recovery.

详细描述

Participants with unilateral Bell's palsy will be recruited for a single assessment session. The assessment involves two primary components:

Clinical Assessment: A qualified physical therapist will grade the patient's facial function using the Sunnybrook Facial Grading System, which evaluates resting symmetry, degree of voluntary movement, and synkinesis.

AI Assessment: A computer-vision-based system will utilize a standard camera to detect 468 facial landmarks in real-time. The system calculates a composite asymmetry score by comparing the movement amplitude and positioning of the affected side of the face against the healthy side during standardized facial expressions.

The study will utilize Spearman's rank correlation coefficient to analyze the relationship between the AI-derived scores and the Sunnybrook scores to establish concurrent validity. No personal images or videos will be stored; the AI performs real-time processing and immediate data deletion to ensure participant privacy.

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
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral Bell's palsy.
  • Patients must be within one month of onset of Bell's palsy symptoms at the time of enrollment.
  • Body mass index (BMI) less than 30 $kg/m^2$.
  • Patients must be cooperative and able to follow simple verbal instructions during facial movement tasks.

排除标准

  • Bilateral facial paralysis or recurrent Bell's palsy.
  • Facial nerve palsy due to known secondary causes (e.g., trauma, neoplasm, infection, stroke, Ramsay Hunt syndrome, or otitis media).
  • Facial deformities, scars, or burns that interfere with facial motion detection.
  • Uncooperative or cognitively impaired individuals unable to follow instructions or maintain required facial postures.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Noureldin Elsayed

Master's Degree Candidate, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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