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Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation. (EPA-DBS)

2026年10月1日 更新者:Medical University of Warsaw

Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.

Parkinson's disease is a common, progressive neurodegenerative disorder. The degeneration of dopaminergic neurons is associated with characteristic clinical symptoms such as tremor, rigidity, slowness of movement (bradykinesia) and postural instability. Subthalamic nucleus deep brain stimulation (DBS-STN) is a recognized and widely used method of treating advanced stages of Parkinson's disease. It improves clinical symptoms such as tremor, rigidity and slowness of movement (bradykinesia). This method has limited application for late motor and non-motor symptoms such as: akinesia, postural instability, gait, including the phenomenon of "freezing", recurrent falls, balance and dysarthria. These symptoms reduce the quality of life of patients and make them dependent on their caregivers. There is a clear need to develop additional forms of therapy that complement deep brain stimulation in controlling late motor and non-motor symptoms.

Physical activity is a commonly used and recommended form of therapy for patients with Parkinson's disease and a complement to pharmacological therapy, improving gait, balance and quality of life. However, there are no clear recommendations including patients after implantation of DBS-STN stimulators to the group undergoing physiotherapy. To this day, only one clinical trial has been registered assessing the effect of physiotherapy on balance and gait in patients with DBS-STN.

研究概览

研究类型

介入性

注册 (估计的)

102

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Warsaw、波兰、03-242
        • 招聘中
        • Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients diagnosed with idiopathic Parkinson's disease (ICD-10:G20).
  • Patients qualified for advanced therapies using DBS-STN.
  • Grade II-IV on the Hoehn & Yahr scale.
  • Age 50-70.
  • Consent to participate in the study.

Exclusion Criteria:

  • Patients diagnosed with atypical parkinsonism.
  • Patients not eligible for advanced therapies with DBS-STN.
  • Hoehn & Yahr Grade I and V.
  • Age <50 and >70
  • Patients diagnosed with dementia syndrome (MMSE < 24/30).
  • Diseases of the osteoarticular system and muscles that make it impossible to undergo rehabilitation.
  • Severe kidney, liver and heart failure.
  • Active malignancy or malignancy diagnosed and treated within 3 years prior to the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
假比较器:控制组

Direct education of the patient in the field of self-care, counseling and instruction on independent exercise, use of medical equipment or devices, also at home.

实验性的:研究小组

Assessment of the patient's functional status: 10 Meter Walk (10 MW) Test, Tinetti Test, New Freezing of Gait Questionnaire (NFOG-Q), History of Falling Questionaire, Timed up and go (TUG), TUG - countdown from 100 to 80, TUG - cup half-filled with water carried in the right and left hand, TST - 10 s standing in a tandem position, 180 Tandem Pivot Test, TWT - Tandem Walking Test, Functional Reach test, Functional strength test, TEST Six Minute Walk (6MWT), Berg Balance Scale, Treadmill Gait Analysis, Platform Stabilometry Test.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination
大体时间:2 years

Change in the full Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination, score in the full ON medication/DBS state from baseline to study completion, comparing the control and study groups, with subsequent study time points also reported. Part III assesses the severity of motor signs of Parkinson's disease. The total score ranges from 0 to 132, with 0 indicating no motor impairment and higher scores indicating greater motor impairment (i.e., a worse outcome).

2 years

次要结果测量

结果测量
措施说明
大体时间
Tinetti Performance-Oriented Mobility Assessment (POMA)
大体时间:2 years

Change in the full Tinetti Performance-Oriented Mobility Assessment (POMA), also known as the Tinetti Mobility Test, total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The POMA assesses balance and gait/mobility. The total score ranges from 0 to 28 points (balance: 0-16; gait: 0-12), with higher scores indicating better mobility, gait, and balance function (i.e., a better outcome).

2 years
New Freezing of Gait Questionnaire (NFOG-Q)
大体时间:2 years

Change in the full New Freezing of Gait Questionnaire (NFOG-Q) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The NFOG-Q is a patient-reported measure assessing the severity of freezing of gait and its impact on daily life in people with Parkinson's disease. The total score ranges from 0 to 28 points, with 0 indicating no freezing of gait and higher scores indicating greater severity and impact of freezing of gait (i.e., a worse outcome).

2 years
Berg Balance Scale (BBS)
大体时间:2 years

Change in the full Berg Balance Scale (BBS) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The BBS is a 14-item performance-based measure of functional balance. Each item is scored from 0 to 4, giving a total score ranging from 0 to 56 points, with higher scores indicating better balance and functional performance (i.e., a better outcome).

2 years
Montreal Cognitive Assessment (MoCA)
大体时间:2 years

Change in the full Montreal Cognitive Assessment (MoCA) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The MoCA is a cognitive screening assessment of multiple cognitive domains, including executive function, visuospatial abilities, attention, memory, language, and orientation. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance (i.e., a better outcome).

2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月5日

初级完成 (估计的)

2027年9月5日

研究完成 (估计的)

2028年9月5日

研究注册日期

首次提交

2026年9月17日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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