Virtual Reality for Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT03637023
• Recruitment Status: Terminated
• First Posted: August 17, 2018
• Last Update Posted: October 19, 2021
• Sponsor: Farzin Hajebrahimi, PT, MSc
• Information provided by (Responsible Party): Farzin Hajebrahimi, PT, MSc, Istanbul Medipol University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Virtual Reality Therapy; Functional Magnetic Resonance Imaging	Behavioral: Virtual Reality; Behavioral: Exercise Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical and Rest-fMRI Effects of Virtual Reality Practice on Motor and Cognitive Symptoms in Parkinson's Disease, a Randomized Control Trial
• Actual Study Start Date: August 18, 2018
• Actual Primary Completion Date: March 12, 2020
• Actual Study Completion Date: August 30, 2020

Arms and Interventions

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 Name: 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 Name: Conventional Physical Therapy

Outcome Measures

Primary Outcome Measures :

1. Motor Level [ Time Frame: Change from Baseline at 4 weeks. ]
   Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)
2. Cognitive Level [ Time Frame: Change from Baseline at 4 weeks. ]
   Montreal Cognitive Asssessment (MoCA)
3. Neuroplasticity [ Time Frame: Change from Baseline at 4 weeks. ]
   Resting State Networks functional connectivity

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Istanbul Medipol University Hospital

Istanbul, Bağcılar, Turkey, 34214

Sponsors and Collaborators

Farzin Hajebrahimi, PT, MSc

Investigators

• Principal Investigator: Farzin Hajebrahimi; Medipol University
• Study Director: Lutfu Hanoglu, Professor; Medipol University

More Information

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:CD010760. doi: 10.1002/14651858.CD010760.pub2. Review.

• Responsible Party: Farzin Hajebrahimi, PT, MSc, Principle Investigator, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT03637023
• Other Study ID Numbers: PD-VR-2018
• First Posted: August 17, 2018
• Last Update Posted: October 19, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be available to the public.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Farzin Hajebrahimi, PT, MSc, Istanbul Medipol University Hospital:

fMRI; Virtual Reality Therapy; Exercise Therapy

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases