Facial ParalysisNCT07750561
Turkish Validation of the Synkinesis Assessment Questionnaire (SAQ)
An observational study of Facial Paralysis and Facial Palsy, run by Barış CELBEK at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Facial Paralysis, Facial Palsy, Bell Palsy
- What is being tested?
- Synkinesis Assessment Questionnaire (SAQ)
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 31 Dec 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Turkish Cross-Cultural Adaptation, Validity, and Reliability of the Synkinesis Assessment Questionnaire (SAQ) in Patients With Peripheral Facial Palsy
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, Facial Palsy, Bell Palsy
- Being tested
- Synkinesis Assessment Questionnaire (SAQ)
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Synkinesis Assessment Questionnaire (SAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Barış CELBEK
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Sponsor-investigator, Barış CELBEK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750561
- Sponsor's protocol ID
- 2024-BİAEK/20-34
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Cross-Cultural Adaptation, Validity, and Reliability of the Synkinesis Assessment Questionnaire (SAQ) in Patients With Peripheral Facial Palsy
- ClinicalTrials.gov ID
- NCT07750561
- Acronym / sponsor ID
- 2024-BİAEK/20-34
- Conditions
- Facial Paralysis, Facial Palsy, Bell Palsy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Barış CELBEKUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Peripheral Facial Palsy and Synkinesis | – | Other: Synkinesis Assessment Questionnaire (SAQ)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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adults With Peripheral Facial Palsy and Synkinesis |
Primary outcome
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.
2 secondary outcomes
Facial Disability Index (FDI)
Time frame: Baseline
Sunnybrook Facial Grading System (SFGS) Total Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Paralysis and Facial Palsy, run by Barış CELBEK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score (time frame: Baseline and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.