Virtual Reality for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Clinical and Rest-fMRI Effects of Virtual Reality Practice on Motor and Cognitive Symptoms in Parkinson's Disease, a Randomized Control Trial

Conditions
-----------------
Parkinson Disease, Virtual Reality Therapy, Functional Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality
* Behavioral: Exercise Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Virtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist. | Behavioral: Virtual Reality<br>* Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking<br>* Other names: Nintendo Wii;|
| Active Comparator: Exercise Therapy<br>Exercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist. | Behavioral: Exercise Therapy<br>* The conventional physical Therapy program includes parameters for improving strength, flexibility, transfers, posture, balance and coordination, and sensory stimulation. These activities consist of various types of exercises that focus on lower extremity movements.<br>* Other names: Conventional Physical Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Level | Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III) | Change from Baseline at 4 weeks. | 
| Cognitive Level | Montreal Cognitive Asssessment (MoCA) | Change from Baseline at 4 weeks. | 
| Neuroplasticity | Resting State Networks functional connectivity | Change from Baseline at 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Berg Balance Scale (BBS) | Change from Baseline at 4 weeks. | 
| Quality of Life in patients with Parkinson's Disease | The Parkinson's Disease Questionnaire (PDQ-39) | Change from Baseline at 4 weeks. | 
| Mobility | Timed Up and Go Test (TUG), | Change from Baseline at 4 weeks. | 
| Functional Capacity | Six Minute Walk Test (6MWT) | Change from Baseline at 4 weeks. | 
| Depression | The Geriatric Depression Scale (GDS) | Change from Baseline at 4 weeks. | 
| Balance Confidence | The Activities-specific Balance Confidence (ABC) Scale | Change from Baseline at 4 weeks. | 
| Cognitive Assessment | Neuropsychological assessment test (NPT) battery | Change from Baseline at 4 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fMRI, Virtual Reality Therapy, Exercise Therapy