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Virtual Reality for Parkinson's Disease

NCT ID: NCT03637023

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-18

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Virtual Reality Therapy Functional Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Virtual Reality

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

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

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

Exercise Therapy

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

Group Type ACTIVE_COMPARATOR

Exercise Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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Virtual Reality

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Nintendo Wii Conventional Physical Therapy

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farzin Hajebrahimi, PT, MSc

OTHER

Sponsor Role lead

Responsible Party

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Farzin Hajebrahimi, PT, MSc

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Farzin Hajebrahimi

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Lutfu Hanoglu, Professor

Role: STUDY_DIRECTOR

Medipol University

Locations

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Istanbul Medipol University Hospital

Istanbul, Bağcılar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28000926 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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PD-VR-2018

Identifier Type: -

Identifier Source: org_study_id