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NCT Number: NCT07573358

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

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.

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Key information

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 12613, Egypt

Location contact

Ali Noureldin Hassanein, B.Sc.

CONTACT

[email protected]

01142154162

Ali Noureldin Hassanein, B.Sc.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sunnybrook Facial Grading System (FGS)

Other

Clinical grading of facial muscle paralysis based on resting symmetry, symmetry of voluntary movements, and synkinesis detection.

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.

Primary outcomes

  1. Spearman's Rank Correlation Coefficient between AI-derived scores and Sunnybrook Facial Grading System scores.

    Time frame: 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.

Secondary outcomes

  1. AI-Based Composite Asymmetry Score.

    Time frame: Baseline.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Noureldin Hassanein, B.Sc., PT.

CONTACT

[email protected]

+201142154162

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: AI-FACE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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