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临床试验/NCT04737811
NCT04737811已完成不适用

Validation and Reliability of the Turkish Translation of the Swallowing Disturbance Questionnaire in Parkinson's Disease Patients

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2020年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
1
主要终点
Penetration and aspiration scale

研究概览

简要总结

Purpose of the study is the validity and reliability of the Turkish version of the Swallowing Disturbance Questionnaire (SDQ-T), so that it would be used as an assessment tool for Turkish Parkinson Disease's (PD) patients. Despite being translated and validated in many languages, there is no validated Turkish version of SDQ to measure the severity of dysphagia in PD.

详细描述

Parkinson's disease (PD) patients who suffered from dysphagia have reported significantly reduced quality of life. The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of dysphagia in PD but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Swallowing Disturbance Questionnaire. The investigators developed the Turkish version of this questionnaire (SDQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SDQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SDQ questionnaire consisted of 15 basic questions related with dysphagia symptoms in PD patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Parkinson's disease
  • Able to speak, read, understand and write in Turkish
  • Taking food orally
  • Malignancy
  • Having an active infection
  • Advanced demans or

排除标准

  • Diagnosed with other neurodegenerative disorders.
  • Able not to speak, read, understand and write in Turkish
  • Advanced demeans or other cognitive limitations
  • Underwent any surgery last six months
  • Pregnancy
  • Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
  • Out of age 18-80 years old.

结局指标

主要结局

Penetration and aspiration scale

时间窗: Baseline

The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.

Turkish Version of Swallow Disturbance Questionnaire

时间窗: 2 weeks

Turkish version of the questionnaire consists of 15 questions about dysphagia and swallowing complaints. The minimum score is 0 and maximum score is 44,5. The lower scores mean a normal swallowing function, higher scores mean worst swallowing functions.

Yale Pharyngeal Residue Severity Rating Scale

时间窗: Baseline

The scale consists of 5 assessment units and two localisations for pharyngeal residue. The scores are from 1 to 5 each localisation. Low score is better, higher score is worse.

次要结局

  • Subject demographics(Baseline)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevgi Atar

Specialist, MD

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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