Clinical and Rest-fMRI Effects of Virtual Reality Practice on Motor and Cognitive Symptoms in Parkinson's Disease, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Motor Level
研究概览
简要总结
Parkinson's Disease (PD) is one of the most common neurodegenerative disease. Bradykinesia, tremor, resting tremor and postural instability are the main motor characteristics of this disease. As the disease progresses, mobility, walking, balance are reducing, the risk of falls is increasing and patients become functionally dependent. Along with these symptoms, cognitive functions are also disturbed. The most commonly distorted cognitive functions are executive functions such as planning and reasoning, working memory, episodic memory, attention and visual-spatial skills. Pharmacological and surgical treatments are used in Parkinson's disease. Pharmacologic treatment has a proven effect on motor symptoms, but since there is no approved pharmacologic treatment which has a direct effect on cognitive functions, recent studies suggest non-pharmacological treatments to improve cognitive function. Physiotherapy is also accepted among non-pharmacological treatments. Conventional physiotherapy focuses on optimizing patient independence and safety, focusing on hinting strategies, cognitive movement strategies and exercises utilizing transfers, posture, upper extremity function, balance (and falls), gait, physical capacity and (in)activity. Virtual Reality (VR) technology, a promising commonly used new rehabilitation tool, is a treatment method that can be used as one of the non-pharmacological treatment methods in Parkinson's Disease. In order to understand how neuronal network dysfunction in the Parkinson's Disease leads to clinical symptoms, both the component elements and the interconnections within these networks need to be examined in greater detail. Studies of resting state-fMRI (rs-fMRI) use correlation of activation of brain regions and time series fluctuations between brain regions to give information about connectivity in brain.
The purpose of this study is to investigate the therapeutic effects of virtual reality on motor and cognitive symptoms of PD. Furthermore, the investigation of possible effects of this effect on neuroplasticity through functional brain networks is our other objective. This study will be the first study to evaluate the plasticity effect of virtual reality application with rs-fMRI in Parkinson's disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be 50 years old and older
- •Clinical diagnosis of PD within the -framework of Brain Bank criteria
- •Getting a stable antiparkinsonian medication at least for the last 1 month (or the treatment has not changed)
排除标准
- •Having a story of unstable medical condition
- •History of head trauma, stroke, or exposure to toxic substances
- •Implying Parkinson plus syndromes in neurological examinations; pyramidal, cerebellar examination findings, gaze paresis, autonomic dysfunction
- •Being diagnosed with Dementia
结局指标
主要结局
Motor Level
时间窗: Change from Baseline at 4 weeks.
Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)
Neuroplasticity
时间窗: Change from Baseline at 4 weeks.
Resting State Networks functional connectivity
Cognitive Level
时间窗: Change from Baseline at 4 weeks.
Montreal Cognitive Asssessment (MoCA)
次要结局
- Balance(Change from Baseline at 4 weeks.)
- Mobility(Change from Baseline at 4 weeks.)
- Balance Confidence(Change from Baseline at 4 weeks.)
- Quality of Life in patients with Parkinson's Disease(Change from Baseline at 4 weeks.)
- Functional Capacity(Change from Baseline at 4 weeks.)
- Depression(Change from Baseline at 4 weeks.)
- Cognitive Assessment(Change from Baseline at 4 weeks.)
研究者
Farzin Hajebrahimi, PT, MSc
Principle Investigator
Istanbul Medipol University Hospital