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临床试验/NCT03797976
NCT03797976Unknown不适用

The Effects Of Deep Brain Stimulation Of Subthalamıc Nucleus On Pulmonary Function Tests and Functionality In Patıents With Parkinson's Disease: Short Term Results

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Functional exercise capacity

研究概览

简要总结

Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson's Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson's disease.

详细描述

In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Lack of any neurological disease other than Parkinson's
  • •DBS surgery to be performed in the STN region

排除标准

  • •Patients with advanced cognitive impairment
  • •Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
  • •Pregnancy
  • •Patients in whom the stimulation was canceled due to infection after surgery.

研究组 & 干预措施

Parkinson's Disease Group

Experimental

MIP and MEP Respiratory Function Test Strength Test

干预措施: MIP and MEP (Device)

结局指标

主要结局

Functional exercise capacity

时间窗: Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months

6 minute walking test

次要结局

  • Muscle strength(Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months)
  • Grip Test (Peripheral muscle strength)(Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months)
  • Pulmonary functions(Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months)
  • Inspiratory and expiratory muscle strength (MIP, MEP)(Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bircan Yücekaya

Lecturer

Mustafa Kemal University

研究点 (1)

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