跳至主要内容
临床试验/NCT07838636
NCT07838636招募中不适用

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

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
102
试验地点
1
主要终点
Part III UPDRS-MDS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •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.
  • •Consent to participate in the study.

排除标准

  • •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.

研究组 & 干预措施

Research group

Experimental

干预措施: Physiotherapy (Procedure)

Control group

Sham Comparator

干预措施: Education about physiotherapy (Behavioral)

结局指标

主要结局

Part III UPDRS-MDS

时间窗: 2 years

Change in full ON-state score (Drugs+DBS) in Part III of the UPDRS-MDS Scale before and after study completion in control vs. study and subsequent study time points.

次要结局

  • Tinetti Scale(2 years)
  • NFOG-Q(2 years)
  • Berg Balance Scale(2 years)
  • MoCA Scale(2 years)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验