An observational study in Facial Paralysis, Facial Palsy and Bell Palsy, sponsored by Barış CELBEK. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Barış CELBEK · Observational
Peripheral facial palsy may result in synkinesis, a condition characterized by involuntary facial muscle movements that occur during voluntary facial expressions. Synkinesis can negatively affect facial function, appearance, and quality of life. The Synkinesis Assessment Questionnaire (SAQ) is a patient-reported outcome measure developed to assess the severity and impact of synkinesis. However, a validated Turkish version is not currently available.
The aim of this study is to translate and culturally adapt the SAQ into Turkish and to evaluate its validity and reliability in Turkish-speaking adults with peripheral facial palsy and synkinesis. The Turkish version will be developed using a standardized forward-backward translation process. Participants will complete the Turkish SAQ and the Facial Disability Index (FDI). Reliability, internal consistency, and construct validity will be evaluated to determine whether the Turkish SAQ is a valid and reliable instrument for clinical practice and research.
81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.
This study's planned enrollment of 49 is below the median of 80 across 21 observational studies indexed under Facial Paralysis.
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The study population will consist of Turkish-speaking adults (≥18 years) with clinically confirmed synkinesis secondary to peripheral facial palsy for at least 6 months. Participants will be recruited from outpatient clinics and will undergo assessment using the Turkish version of the Synkinesis Assessment Questionnaire (SAQ), the Facial Disability Index (FDI), and the Sunnybrook Facial Grading System (SFGS) as part of the psychometric evaluation of the Turkish SAQ.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include adults (≥18 years) with peripheral facial palsy who have clinically confirmed synkinesis for at least 6 months after symptom onset. Participants will complete the Turkish version of the Synkinesis Assessment Questionnaire (SAQ) and the Facial Disability Index (FDI) during the baseline assessment. The Turkish SAQ will be administered again one week later to evaluate test-retest reliability. Data obtained from these assessments will be used to examine the validity, reliability, and psychometric properties of the Turkish version of the SAQ.
Other: Synkinesis Assessment Questionnaire (SAQ)
Participants will complete the Turkish version of the Synkinesis Assessment Questionnaire (SAQ), developed through a standardized forward-backward translation and cross-cultural adaptation process. The questionnaire consists of nine patient-reported items assessing the frequency and severity of synkinetic facial movements during daily activities. Participants will also complete the Facial Disability Index (FDI) during the initial assessment. To evaluate test-retest reliability, the Turkish SAQ will be administered again one week after the baseline assessment.
Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score
The primary outcome is the psychometric evaluation of the Turkish version of the Synkinesis Assessment Questionnaire (SAQ), including internal consistency, test-retest reliability, and construct validity. The SAQ is a 9-item patient-reported outcome measure assessing the frequency and severity of synkinesis. Total scores are transformed to a 0-100 scale, with higher scores indicating more severe synkinesis.
Time frame: Baseline and 1 week
Facial Disability Index (FDI)
The Facial Disability Index (FDI) will be used to assess the construct validity of the Turkish version of the Synkinesis Assessment Questionnaire (SAQ). The FDI is a 10-item patient-reported outcome measure comprising two subscales: Physical Function and Social/Well-Being Function. Each subscale is transformed to a score ranging from 0 to 100, with higher scores indicating better facial function and quality of life. Correlations between SAQ and FDI scores will be examined to evaluate construct validity.
Time frame: Baseline
Sunnybrook Facial Grading System (SFGS) Total Score
The Sunnybrook Facial Grading System (SFGS) will be used to evaluate facial nerve function and the severity of synkinesis. The instrument assesses resting symmetry, voluntary facial movement, and synkinesis to generate a composite score ranging from 0 to 100, with higher scores indicating better facial function. The SFGS will be used to examine the construct validity of the Turkish version of the Synkinesis Assessment Questionnaire (SAQ).
Time frame: Baseline
Plan to share: No
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