Turkish Validation of the Synkinesis Assessment Questionnaire (SAQ)

NCT07750561 | Enrolling By Invitation

• 1 other identifier: 2024-BİAEK/20-34
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Paralysis; Bell Palsy; Facial Palsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 week

Secondary Outcomes (2)

• Facial Disability Index (FDI)

  Baseline

• Sunnybrook Facial Grading System (SFGS) Total Score

  Baseline

Study Arms (1)

Adults With Peripheral Facial Palsy and Synkinesis

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)

Interventions

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.

Adults With Peripheral Facial Palsy and Synkinesis

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barış CELBEK: lead
• Biruni University: collaborator

Study Sites (1)

Biruni University

Istanbul, Cevizlibağ, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Paralysis; Bell Palsy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)