Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.
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
干预措施: Physiotherapy (Procedure)
Control group
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)
