- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07780370
Video-Based Facial Movement Analysis in Facial Paralysis
26. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
49
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-post: 241119002@st.biruni.edu.tr
Studer Kontakt Backup
- Navn: Zeynep Hoşbay, Proff.
- E-post: zhosbay@biruni.edu.tr
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34015
- Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Ta kontakt med:
- Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-post: 241119002@st.biruni.edu.tr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
20. februar 2027
Studiet fullført (Antatt)
20. juni 2027
Datoer for studieregistrering
Først innsendt
19. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-BİAEK/20-33
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