- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07780370
Video-Based Facial Movement Analysis in Facial Paralysis
26. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
49
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-mail: 241119002@st.biruni.edu.tr
Undersøgelse Kontakt Backup
- Navn: Zeynep Hoşbay, Proff.
- E-mail: zhosbay@biruni.edu.tr
Studiesteder
-
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Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye), 34015
- Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Kontakt:
- Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-mail: 241119002@st.biruni.edu.tr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult patients diagnosed with facial paralysis presenting for clinical evaluation.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement Between Video-Based Objective Facial Motion Analysis and Clinical Facial Assessment Scale Scores
Tidsramme: Single assessment session (Day 1)
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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.
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Single assessment session (Day 1)
|
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Sunnybrook Facial Grading System
Tidsramme: 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.
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Baseline
|
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FDI (Facial Disability Index):
Tidsramme: 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.
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Baseline
|
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House-Brackmann Facial Grading System (HBGS)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
20. februar 2027
Studieafslutning (Anslået)
20. juni 2027
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-BİAEK/20-33
Plan for individuelle deltagerdata (IPD)
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