Virtual Reality for Parkinson's Disease

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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Functional Magnetic Resonance Imaging; Virtual Reality Therapy
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Exercise Therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bağcılar
    • Istanbul, Bağcılar, Turkey, 34214
      • Istanbul Medipol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Virtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.	Behavioral: Virtual Reality; Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking; Other Names: Nintendo Wii
Active Comparator: Exercise Therapy; Exercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.	Behavioral: Exercise Therapy; 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.; 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.

Collaborators and Investigators

• Sponsor: Farzin Hajebrahimi, PT, MSc
• Investigators: Principal Investigator: Farzin Hajebrahimi, Medipol University; Study Director: Lutfu Hanoglu, Professor, Medipol University

Publications and helpful links

General Publications

• Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: fMRI; Exercise Therapy; Virtual Reality Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD-VR-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No