Virtual Reality for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03637023
• Other study ID #: PD-VR-2018
• Status: Terminated
• Phase: N/A
• Start date: August 18, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2021
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 30, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Virtual Reality
Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Farzin Hajebrahimi, PT, MSc

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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:CD010760. doi: 10.1002/14651858.CD010760.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Level	Unified Parkinson's Disease Rating Scale-Motor (UPDRS-III)	Change from Baseline at 4 weeks.
Primary	Cognitive Level	Montreal Cognitive Asssessment (MoCA)	Change from Baseline at 4 weeks.
Primary	Neuroplasticity	Resting State Networks functional connectivity	Change from Baseline at 4 weeks.
Secondary	Balance	Berg Balance Scale (BBS)	Change from Baseline at 4 weeks.
Secondary	Quality of Life in patients with Parkinson's Disease	The Parkinson's Disease Questionnaire (PDQ-39)	Change from Baseline at 4 weeks.
Secondary	Mobility	Timed Up and Go Test (TUG),	Change from Baseline at 4 weeks.
Secondary	Functional Capacity	Six Minute Walk Test (6MWT)	Change from Baseline at 4 weeks.
Secondary	Depression	The Geriatric Depression Scale (GDS)	Change from Baseline at 4 weeks.
Secondary	Balance Confidence	The Activities-specific Balance Confidence (ABC) Scale	Change from Baseline at 4 weeks.
Secondary	Cognitive Assessment	Neuropsychological assessment test (NPT) battery	Change from Baseline at 4 weeks.