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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Unilateral Bell's Palsy | Sixty-three patients of both sexes, aged 25-40 years, with a body mass index (BMI) less than 30 $kg/m^2$. Participants must be within one month of the onset of Bell's palsy symptoms and be able to follow verbal instructions during facial movement tasks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunnybrook Facial Grading System (FGS) | Other | Clinical grading of facial muscle paralysis based on resting symmetry, symmetry of voluntary movements, and synkinesis detection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spearman's Rank Correlation Coefficient between AI-derived scores and Sunnybrook Facial Grading System scores. | This measure evaluates the concurrent validity of the AI-based assessment system. The AI system uses 468 facial landmarks to calculate a composite asymmetry score (0-100%). These results will be correlated with the clinical scores from the Sunnybrook Facial Grading System (0-100), where higher scores indicate better facial function. | Baseline (single assessment at the time of enrollment). |
| Measure | Description | Time Frame |
|---|---|---|
| AI-Based Composite Asymmetry Score. | The specific numerical output generated by the computer-vision system. It quantifies facial symmetry by measuring the amplitude of movement (in pixels/displacement) during five standardized facial expressions: brow lift, eye closure, broad smile, snarl, and lip pucker. | Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Sixty-three patients of both sexes with unilateral Bell's palsy will be recruited from private clinics. Patients will be diagnosed by a neurologist based on clinical examination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Noureldin Hassanein, B.Sc., PT. | Contact | +201142154162 | alionour22@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ali Noureldin Hassanein, B.Sc. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Giza | Giza Governorate | 12613 | Egypt |
To maintain participant confidentiality and privacy. The AI system processes facial landmarks in real-time, and no individual images or raw biometric data are stored for future distribution
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| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| D005146 | Facial Asymmetry |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| AI-Based Facial Assessment | Other | Real-time computer vision analysis using deep-learning-based landmark detection to track 468 facial points during standardized facial expressions. |
|
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |