Bell's PalsyAI-FACENCT07573358
Validation of Artificial Intelligence-Based Facial Paralysis Assessment in Patients With Bell's Palsy
An observational study of Bell's Palsy and Facial Nerve Paralysis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Bell's Palsy, Facial Nerve Paralysis
- What is being tested?
- Sunnybrook Facial Grading System (FGS) and AI-Based Facial Assessment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 12613
Ali Noureldin Hassanein, B.Sc., 01142154162, alionour22@gmail.com
Ali Noureldin Hassanein, B.Sc.
About this study
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.
Read the detailed description
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.
- Conditions
- Bell's Palsy, Facial Nerve Paralysis
- Being tested
- Sunnybrook Facial Grading System (FGS), AI-Based Facial Assessment
- Keywords
- Facial Asymmetry, Artificial Intelligence, Sunnybrook Facial Grading System, Computer Vision
- Medical subject headings
- Bell Palsy, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AssessmentOther
Real-time computer vision analysis using deep-learning-based landmark detection to track 468 facial points during standardized facial expressions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sunnybrook Facial Grading System (FGS); Other: AI-Based Facial Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single assessment at the time of enrollment).
Secondary outcomes (1)
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.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Noureldin Elsayed, Cairo University
- Investigators
- Ali Noureldin Hassanein, B.Sc., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573358
- Sponsor's protocol ID
- P.T.REC/012/006311
- Acronym
- AI-FACE
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Artificial Intelligence-Based Facial Paralysis Assessment in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT07573358
- Acronym / sponsor ID
- AI-FACE / P.T.REC/012/006311
- Conditions
- Bell's Palsy, Facial Nerve Paralysis
- Keywords
- Facial Asymmetry, Artificial Intelligence, Sunnybrook Facial Grading System, Computer Vision
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Unilateral Bell's Palsy | – | Other: Sunnybrook Facial Grading System (FGS), Other: AI-Based Facial AssessmentSixty-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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunnybrook Facial Grading System (FGS)Clinical grading of facial muscle paralysis based on resting symmetry, symmetry of voluntary movements, and synkinesis detection. | Other | Patients with Unilateral Bell's Palsy |
| AI-Based Facial AssessmentReal-time computer vision analysis using deep-learning-based landmark detection to track 468 facial points during standardized facial expressions. | Other | Patients with Unilateral Bell's Palsy |
Primary outcome
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.
1 secondary outcome
AI-Based Composite Asymmetry Score.
Time frame: Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Noureldin Hassanein, B.Sc. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bell's Palsy and Facial Nerve Paralysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Noureldin Hassanein, B.Sc., PT. (+201142154162, alionour22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.