CClinicalTrials.gg
TerminatedNCT03637023Updated Oct 19, 2021

Virtual Reality for Parkinson's Disease

An interventional study of Virtual Reality and Exercise Therapy in Parkinson Disease, Virtual Reality Therapy and Functional Magnetic Resonance Imaging, sponsored by Farzin Hajebrahimi, PT, MSc. Terminated at 1 site in Turkey. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by Farzin Hajebrahimi, PT, MSc · Not applicable, Interventional, and Treatment

Why this study was terminated
due to COVID-19 outbreak
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Parkinson Disease
  • Virtual Reality Therapy
  • Functional Magnetic Resonance Imaging

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Keywords

  • fMRI
  • Virtual Reality Therapy
  • Exercise Therapy
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Farzin Hajebrahimi, PT, MSc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Virtual Reality

    Virtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.

    Behavioral: Virtual Reality

  • Active comparator
    Exercise Therapy

    Exercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.

    Behavioral: Exercise Therapy

Interventions

  • BehavioralVirtual Reality

    Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking

    Also known as: Nintendo Wii

  • BehavioralExercise 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.

    Also known as: Conventional Physical Therapy

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What researchers measure

Primary outcomes

  1. Motor Level

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

    Time frame: Change from Baseline at 4 weeks.

  2. Cognitive Level

    Montreal Cognitive Asssessment (MoCA)

    Time frame: Change from Baseline at 4 weeks.

  3. Neuroplasticity

    Resting State Networks functional connectivity

    Time frame: Change from Baseline at 4 weeks.

Secondary outcomes

  1. Balance

    Berg Balance Scale (BBS)

    Time frame: Change from Baseline at 4 weeks.

  2. Quality of Life in patients with Parkinson's Disease

    The Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Change from Baseline at 4 weeks.

  3. Mobility

    Timed Up and Go Test (TUG),

    Time frame: Change from Baseline at 4 weeks.

  4. Functional Capacity

    Six Minute Walk Test (6MWT)

    Time frame: Change from Baseline at 4 weeks.

  5. Depression

    The Geriatric Depression Scale (GDS)

    Time frame: Change from Baseline at 4 weeks.

  6. Balance Confidence

    The Activities-specific Balance Confidence (ABC) Scale

    Time frame: Change from Baseline at 4 weeks.

  7. Cognitive Assessment

    Neuropsychological assessment test (NPT) battery

    Time frame: Change from Baseline at 4 weeks.

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Study locations

1 site
  • Istanbul Medipol University Hospital
    Istanbul, Bağcılar 34214, Turkey
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References and documents

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. PubMed 28000926 ↗

Individual participant data

Plan to share: No — Individual participant data will not be available to the public.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03637023
Lead sponsor
Farzin Hajebrahimi, PT, MSc
Responsible party
Farzin Hajebrahimi, PT, MSc (Principle Investigator, Istanbul Medipol University Hospital) — Sponsor-investigator
First posted
Aug 17, 2018
Start date
Aug 18, 2018
Primary completion
Mar 12, 2020
Completion
Aug 30, 2020
Last update
Oct 19, 2021

Study contacts

Farzin Hajebrahimi
principal investigator · Medipol University
Lutfu Hanoglu, Professor
study director · Medipol University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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