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临床试验/NCT06655727
NCT06655727已完成不适用

Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月25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
60
试验地点
1
主要终点
The EAT-10 (Eating Assessment Tool-10)

研究概览

简要总结

The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.

详细描述

Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).

研究设计

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

入排标准

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

入选标准

  • Diagnosis of idiopathic Parkinson's disease by a neurologist.
  • Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
  • Scoring at least 24 on the Mini-Mental State Examination (MMSE).
  • Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.

排除标准

  • Presence of head or neck cancer that could cause dysphagia.
  • History of radiotherapy or surgery in the head and neck region.
  • Diagnosis of vascular parkinsonism or stroke.
  • Presence of cardiopulmonary disease that could affect swallowing or breathing.
  • Having received voice or swallowing therapy in the last 6 months.
  • Presence of a diagnosed psychiatric disorder.

结局指标

主要结局

The EAT-10 (Eating Assessment Tool-10)

时间窗: 0 day

The EAT-10 (Eating Assessment Tool-10) is a validated self-administered questionnaire designed to assess symptoms of dysphagia (difficulty swallowing). It consists of 10 questions that evaluate the severity of swallowing difficulties, including issues related to eating, drinking, and managing saliva. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (severe problem). A total score of 3 or higher suggests the presence of clinically significant dysphagia, and it helps guide further diagnostic evaluation and management.

Unified Parkinson's Disease Rating Scale (UPDRS)

时间窗: 0 day

The UPDRS is a comprehensive tool used to evaluate the severity and progression of Parkinson's disease. It consists of multiple sections assessing motor and non-motor symptoms, helping clinicians understand the impact of the disease on daily functioning. The UPDRS is widely used in both clinical practice and research to monitor disease progression and treatment effects. In the MDS-UPDRS, higher scores indicate more severe Parkinson's disease symptoms. Each item is rated from 0 (normal) to 4 (severe), with the total score reflecting the overall disease severity. A higher total score means worse motor and non-motor symptoms, indicating greater impairment and reduced quality of life. Lower scores suggest milder symptoms and better functional status.

次要结局

  • Tongue Thickness(0 day)
  • Distance Between the Hyoid and Mandible(0 day)
  • Hyoid Displacement Distance:(0 day)

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

研究点 (1)

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