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Clinical Trials/NCT03637023
NCT03637023
Terminated
Not Applicable

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

Farzin Hajebrahimi, PT, MSc1 site in 1 country30 target enrollmentAugust 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Farzin Hajebrahimi, PT, MSc
Enrollment
30
Locations
1
Primary Endpoint
Motor Level
Status
Terminated
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2018
End Date
August 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Farzin Hajebrahimi, PT, MSc
Responsible Party
Sponsor Investigator
Principal Investigator

Farzin Hajebrahimi, PT, MSc

Principle Investigator

Istanbul Medipol University Hospital

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

Outcomes

Primary Outcomes

Motor Level

Time Frame: Change from Baseline at 4 weeks.

Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)

Neuroplasticity

Time Frame: Change from Baseline at 4 weeks.

Resting State Networks functional connectivity

Cognitive Level

Time Frame: Change from Baseline at 4 weeks.

Montreal Cognitive Asssessment (MoCA)

Secondary Outcomes

  • Balance(Change from Baseline at 4 weeks.)
  • Mobility(Change from Baseline at 4 weeks.)
  • Balance Confidence(Change from Baseline at 4 weeks.)
  • Quality of Life in patients with Parkinson's Disease(Change from Baseline at 4 weeks.)
  • Functional Capacity(Change from Baseline at 4 weeks.)
  • Depression(Change from Baseline at 4 weeks.)
  • Cognitive Assessment(Change from Baseline at 4 weeks.)

Study Sites (1)

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