Virtual Reality for Parkinson's Disease
Primary Purpose
Parkinson Disease, Virtual Reality Therapy, Functional Magnetic Resonance Imaging
Status
Terminated
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality
Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring fMRI, Virtual Reality Therapy, Exercise Therapy
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
Sites / Locations
- Istanbul Medipol University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality
Exercise Therapy
Arm Description
Virtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Exercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Outcomes
Primary Outcome Measures
Motor Level
Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)
Cognitive Level
Montreal Cognitive Asssessment (MoCA)
Neuroplasticity
Resting State Networks functional connectivity
Secondary Outcome Measures
Balance
Berg Balance Scale (BBS)
Quality of Life in patients with Parkinson's Disease
The Parkinson's Disease Questionnaire (PDQ-39)
Mobility
Timed Up and Go Test (TUG),
Functional Capacity
Six Minute Walk Test (6MWT)
Depression
The Geriatric Depression Scale (GDS)
Balance Confidence
The Activities-specific Balance Confidence (ABC) Scale
Cognitive Assessment
Neuropsychological assessment test (NPT) battery
Full Information
NCT ID
NCT03637023
First Posted
August 10, 2018
Last Updated
October 12, 2021
Sponsor
Farzin Hajebrahimi, PT, MSc
1. Study Identification
Unique Protocol Identification Number
NCT03637023
Brief Title
Virtual Reality for 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
due to COVID-19 outbreak
Study Start Date
August 18, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Farzin Hajebrahimi, PT, MSc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Virtual Reality Therapy, Functional Magnetic Resonance Imaging
Keywords
fMRI, Virtual Reality Therapy, Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Virtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Arm Title
Exercise Therapy
Arm Type
Active Comparator
Arm Description
Exercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Nintendo Wii
Intervention Description
Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking
Intervention Type
Behavioral
Intervention Name(s)
Exercise Therapy
Other Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor Level
Description
Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)
Time Frame
Change from Baseline at 4 weeks.
Title
Cognitive Level
Description
Montreal Cognitive Asssessment (MoCA)
Time Frame
Change from Baseline at 4 weeks.
Title
Neuroplasticity
Description
Resting State Networks functional connectivity
Time Frame
Change from Baseline at 4 weeks.
Secondary Outcome Measure Information:
Title
Balance
Description
Berg Balance Scale (BBS)
Time Frame
Change from Baseline at 4 weeks.
Title
Quality of Life in patients with Parkinson's Disease
Description
The Parkinson's Disease Questionnaire (PDQ-39)
Time Frame
Change from Baseline at 4 weeks.
Title
Mobility
Description
Timed Up and Go Test (TUG),
Time Frame
Change from Baseline at 4 weeks.
Title
Functional Capacity
Description
Six Minute Walk Test (6MWT)
Time Frame
Change from Baseline at 4 weeks.
Title
Depression
Description
The Geriatric Depression Scale (GDS)
Time Frame
Change from Baseline at 4 weeks.
Title
Balance Confidence
Description
The Activities-specific Balance Confidence (ABC) Scale
Time Frame
Change from Baseline at 4 weeks.
Title
Cognitive Assessment
Description
Neuropsychological assessment test (NPT) battery
Time Frame
Change from Baseline at 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzin Hajebrahimi
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lutfu Hanoglu, Professor
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bağcılar
ZIP/Postal Code
34214
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to the public.
Citations:
PubMed Identifier
28000926
Citation
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.
Results Reference
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Virtual Reality for Parkinson's Disease
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