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Enrolling by invitation NCT07750561

Turkish Validation of the Synkinesis Assessment Questionnaire (SAQ)

Observational Facial Paralysis Facial Palsy Bell Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synkinesis Assessment Questionnaire (SAQ).
Who it may be relevant to
Registry conditions: Facial Paralysis, Facial Palsy, Bell Palsy. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 w

Primary outcome measures

  • Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score [Time frame: Baseline and 1 week]
Secondary outcome measures (2)
  • Facial Disability Index (FDI) [Time frame: Baseline]
  • Sunnybrook Facial Grading System (SFGS) Total Score [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Biruni University — Istanbul

Identifiers

NCT: NCT07750561 · 2024-BİAEK/20-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗