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NCT Number: NCT07750561

Turkish Validation of the Synkinesis Assessment Questionnaire (SAQ)

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.

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Key information

Conditions

Facial Paralysis Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Facial Palsy Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Virus Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Cevizlibağ, 34015, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Diagnosis of peripheral facial palsy.
  • At least 6 months since the onset of peripheral facial palsy.
  • Clinically confirmed facial synkinesis.
  • Ability to read, write, and speak Turkish.
  • Provision of written informed consent to participate in the study.

Exclusion criteria

  • Presence of a secondary neurological disorder that may affect the facial muscles, such as Parkinson's disease or multiple sclerosis.
  • Cognitive impairment or severe psychiatric illness that may prevent understanding or completion of the questionnaires.
  • History of congenital facial palsy.
  • History of major facial surgery or trauma that may affect the assessment of synkinesis.
  • Planned botulinum toxin injection or surgical intervention during the test-retest assessment period.

Treatment and study plan

Synkinesis Assessment Questionnaire (SAQ)

Other

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.

Primary outcomes

  1. Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score

    Time frame: Baseline and 1 week

    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.

Secondary outcomes

  1. Facial Disability Index (FDI)

    Time frame: Baseline

    The Facial Disability Index (FDI) will be used to assess construct validity of the Turkish version of the Synkinesis Assessment Questionnaire (SAQ). The FDI is a 10-item patient-reported outcome measure consisting of two subscales: Physical Function and Social/Well-Being. Higher scores indicate better facial function and quality of life. Correlations between SAQ and FDI scores will be examined to evaluate construct validity.

  2. Sunnybrook Facial Grading System (SFGS) Total Score

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Barış CELBEK

Other

Collaborators

  • Biruni University

Registry information

Official study title

Turkish Cross-Cultural Adaptation, Validity, and Reliability of the Synkinesis Assessment Questionnaire (SAQ) in Patients With Peripheral Facial Palsy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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