跳至主要内容
临床试验/NCT07750561
NCT07750561Enrolling By Invitation不适用

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

Barış CELBEK1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2026年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
49
试验地点
1
主要终点
Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Synkinesis Assessment Questionnaire (SAQ) (Other)

结局指标

主要结局

Turkish Synkinesis Assessment Questionnaire (SAQ) Total Score

时间窗: 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.

次要结局

  • Sunnybrook Facial Grading System (SFGS) Total Score(Baseline)
  • Facial Disability Index (FDI)(Baseline)

研究者

发起方
Barış CELBEK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Barış CELBEK

Lecturer in Physiotherapy and Rehabilitation

Istanbul Aydın University

研究点 (1)

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