Virtual Reality for Parkinson's Disease

NCT03637023 | Terminated DMC

• 1 other identifier: PD-VR-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Virtual Reality Therapy; Functional Magnetic Resonance Imaging

Keywords

fMRI; Virtual Reality Therapy; Exercise Therapy

Outcome Measures

Primary Outcomes (3)

• Motor Level

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

  Change from Baseline at 4 weeks.

• Cognitive Level

  Montreal Cognitive Asssessment (MoCA)

  Change from Baseline at 4 weeks.

• Neuroplasticity

  Resting State Networks functional connectivity

  Change from Baseline at 4 weeks.

Secondary Outcomes (7)

• Balance

  Change from Baseline at 4 weeks.

• Quality of Life in patients with Parkinson's Disease

  Change from Baseline at 4 weeks.

• Mobility

  Change from Baseline at 4 weeks.

• Functional Capacity

  Change from Baseline at 4 weeks.

• Depression

  Change from Baseline at 4 weeks.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Behavioral: Virtual Reality

Exercise Therapy

ACTIVE COMPARATOR

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

Behavioral: Exercise Therapy

Interventions

Virtual Reality BEHAVIORAL

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

Also known as: Nintendo Wii

Virtual Reality

Exercise Therapy 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.

Also known as: Conventional Physical Therapy

Exercise Therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Farzin Hajebrahimi, PT, MSc: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bağcılar, 34214, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28000926 BACKGROUND

• 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Farzin Hajebrahimi

  Medipol University

  PRINCIPAL INVESTIGATOR

• Lutfu Hanoglu, Professor

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 17, 2018
• Study Start: August 18, 2018
• Primary Completion: March 12, 2020
• Study Completion: August 30, 2020
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)