Ireland
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Starting soon Observational

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

NCT07573358 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2026-06-01
Last updated
2026-05-07

Condition(s) studied

Bell's PalsyFacial Nerve Paralysis

Investigational drug(s) / intervention(s)

Sunnybrook Facial Grading System (FGS)AI-Based Facial Assessment

Sunnybrook Facial Grading System (FGS): Clinical grading of facial muscle paralysis based on resting symmetry, symmetry of voluntary movements, and synkinesis detection.

AI-Based Facial Assessment: Real-time computer vision analysis using deep-learning-based landmark detection to track 468 facial points during standardized facial expressions.

Study summary

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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Spearman's Rank Correlation Coefficient between AI-derived scores and Sunnybrook Facial Grading System scores. — Baseline (single assessment at the time of enrollment).
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Physical Therapy, Cairo University Giza Giza Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573358 on ClinicalTrials.gov ↗ ← All trials in Egypt