- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07780370
Video-Based Facial Movement Analysis in Facial Paralysis
August 26, 2026 updated by: Refika Belen Battal, Biruni University
Investigation of the Relationship Between Video-Based Objective Facial Movement Analysis and Clinical Assessment Scales in Patients With Facial Paralysis
This study aims to evaluate facial movements in patients with facial paralysis using video-based objective analysis and to examine the relationship between these video-based measurements and standard clinical assessment scales.
Participants will be asked to perform simple facial movements, such as raising the eyebrows, closing the eyes tightly, smiling, showing the teeth, pursing the lips, and puffing the cheeks, while a video recording is taken.
Researchers will also evaluate participants' facial function using established clinical rating scales and questionnaires.
No medication will be given, no invasive procedures will be performed, and no changes will be made to participants' current treatment.
The goal is to contribute to the development of more detailed, objective, and standardized methods for evaluating facial function in patients with facial paralysis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Belen Battal, PT
- Phone Number: +90 538 864 00 94
- Email: 241119002@st.biruni.edu.tr
Study Contact Backup
- Name: Zeynep Hoşbay, Proff.
- Email: zhosbay@biruni.edu.tr
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34015
- Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Contact:
- Belen Battal, PT
- Phone Number: +90 538 864 00 94
- Email: 241119002@st.biruni.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients diagnosed with facial paralysis presenting for clinical evaluation.
Description
Inclusion Criteria:
- Diagnosis of facial paralysis (e.g., Bell's palsy)
- Age 18 years and older
- Willing and able to provide informed consent
Exclusion Criteria:
- Presence of other neurological or craniofacial conditions affecting facial movement
- Prior facial surgery affecting facial musculature
- Inability to cooperate with video recording or clinical assessment procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Facial Paralysis Patients
Patients diagnosed with facial paralysis who underwent a single evaluation session including video-based objective facial motion analysis and clinical facial function assessment scales.
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Video recording of standardized facial movements (eyebrow raise, eye closure, smile, teeth showing, lip pursing, cheek puffing) followed by objective, video-based analysis and comparison with clinical facial assessment scales.
This is a non-therapeutic, non-invasive assessment procedure and does not constitute a treatment intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between Video-Based Objective Facial Motion Analysis and Clinical Facial Assessment Scale Scores
Time Frame: Single assessment session (Day 1)
|
The degree of agreement/correlation between facial movement parameters obtained from video-based objective analysis and scores obtained from standardized clinical facial assessment scales, evaluated during the same session.
|
Single assessment session (Day 1)
|
|
Sunnybrook Facial Grading System
Time Frame: Baseline
|
The Sunnybrook Facial Grading System (SFGS) is a clinician-rated outcome measure used to assess facial nerve function in individuals with facial paralysis.
The scale evaluates three components: resting facial symmetry, voluntary facial movement, and synkinesis.
Resting symmetry is assessed in the eye, cheek (nasolabial fold), and mouth regions, while voluntary movement is evaluated during five standardized facial expressions.
Synkinesis is scored based on the presence and severity of involuntary associated movements during voluntary facial tasks.
The composite score is calculated using the standard Sunnybrook scoring formula and ranges from 0 to 100, where 0 indicates complete facial paralysis with severe asymmetry and synkinesis, and 100 indicates normal facial function without asymmetry or synkinesis.
Higher scores represent better facial nerve function.
|
Baseline
|
|
FDI (Facial Disability Index):
Time Frame: Baseline
|
The Facial Disability Index (FDI) is a patient-reported outcome measure used to assess the impact of facial paralysis on physical function and social well-being.
The questionnaire consists of 10 items divided into two subscales: Physical Function (5 items) and Social/Well-being Function (5 items).
Each subscale is transformed to a score ranging from 0 to 100, with higher scores indicating better function, less disability, and better health-related quality of life.
Participants complete the questionnaire independently according to their perceived level of facial disability.
|
Baseline
|
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House-Brackmann Facial Grading System (HBGS)
Time Frame: Baseline
|
The House-Brackmann Facial Grading System (HBGS), the Sunnybrook Facial Grading System (SFGS), and the Facial Disability Index (FDI) will be used to evaluate facial nerve function and patient-reported disability.
HBGS is a clinician-rated six-grade scale assessing the overall severity of facial nerve dysfunction.
The Sunnybrook Facial Grading System provides a composite score (0-100) based on resting symmetry, voluntary facial movements, and synkinesis, with higher scores indicating better facial function.
The Facial Disability Index is a patient-reported outcome measure consisting of Physical Function and Social/Well-being subscales (0-100), where higher scores indicate less disability and better quality of life.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 20, 2027
Study Completion (Estimated)
June 20, 2027
Study Registration Dates
First Submitted
August 19, 2026
First Submitted That Met QC Criteria
August 19, 2026
First Posted (Actual)
August 21, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-BİAEK/20-33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.