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Virtual Reality for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637023
Recruitment Status : Suspended (due to COVID-19 outbreak)
First Posted : August 17, 2018
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Farzin Hajebrahimi, PT, MSc, Istanbul Medipol University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 : May 8, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • MoCa score ≥ 21
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637023


Locations
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Turkey
Istanbul Medipol University Hospital
Istanbul, Bağcılar, Turkey, 34214
Sponsors and Collaborators
Farzin Hajebrahimi, PT, MSc
Investigators
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Principal Investigator: Farzin Hajebrahimi Istanbul Medipol University
Study Director: Lutfu Hanoglu, Professor Istanbul Medipol University
Publications:
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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    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to the public.

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