- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07780370
Video-Based Facial Movement Analysis in Facial Paralysis
26 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
49
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-post: 241119002@st.biruni.edu.tr
Studera Kontakt Backup
- Namn: Zeynep Hoşbay, Proff.
- E-post: zhosbay@biruni.edu.tr
Studieorter
-
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Istanbul
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Istanbul, Istanbul, Turkiet (Türkiye), 34015
- Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Kontakt:
- Belen Battal, PT
- Telefonnummer: +90 538 864 00 94
- E-post: 241119002@st.biruni.edu.tr
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult patients diagnosed with facial paralysis presenting for clinical evaluation.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement Between Video-Based Objective Facial Motion Analysis and Clinical Facial Assessment Scale Scores
Tidsram: 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
Tidsram: 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):
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
20 februari 2027
Avslutad studie (Beräknad)
20 juni 2027
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-BİAEK/20-33
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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