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Parkinson DiseaseNCT03637023

Virtual Reality for Parkinson's Disease

A study testing Virtual Reality and Exercise Therapy in people with Parkinson Disease and Virtual Reality Therapy, run by Farzin Hajebrahimi, PT, MSc at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
Virtual Reality and Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Aug 2018to 30 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Medipol University Hospital

    Istanbul, Bağcılar, 34214

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Virtual Reality, Exercise Therapy
Keywords
fMRI, Virtual Reality Therapy, Exercise Therapy
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityBehavioural

    Also called Nintendo Wii

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

  • Exercise TherapyBehavioural

    Also called Conventional Physical 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.

Study groups in NCT03637023
Study groupRoleWhat they receive
Virtual RealityExperimentalVirtual Reality will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Receives: Behavioral: Virtual Reality
Exercise TherapyActive comparatorExercise Therapy will be applied in addition to the Anti-parkinsonian medication given by the Neurologist.
Receives: Behavioral: Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor Level

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

    Measured: Change from Baseline at 4 weeks.

  2. Cognitive Level

    Montreal Cognitive Asssessment (MoCA)

    Measured: Change from Baseline at 4 weeks.

  3. Neuroplasticity

    Resting State Networks functional connectivity

    Measured: Change from Baseline at 4 weeks.

Secondary outcomes (7)

  1. Balance

    Berg Balance Scale (BBS)

    Measured: Change from Baseline at 4 weeks.

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

    The Parkinson's Disease Questionnaire (PDQ-39)

    Measured: Change from Baseline at 4 weeks.

  3. Mobility

    Timed Up and Go Test (TUG),

    Measured: Change from Baseline at 4 weeks.

  4. Functional Capacity

    Six Minute Walk Test (6MWT)

    Measured: Change from Baseline at 4 weeks.

  5. Depression

    The Geriatric Depression Scale (GDS)

    Measured: Change from Baseline at 4 weeks.

  6. Balance Confidence

    The Activities-specific Balance Confidence (ABC) Scale

    Measured: Change from Baseline at 4 weeks.

  7. Cognitive Assessment

    Neuropsychological assessment test (NPT) battery

    Measured: Change from Baseline at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start18 Aug 2018
  3. Primary completion12 Mar 2020
  4. Study completion30 Aug 2020

Why it stopped: due to COVID-19 outbreak

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637023
Sponsor's protocol ID
PD-VR-2018
Status last verified
Oct 2021
First submitted
10 Aug 2018
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available to the public.

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

  • 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.

    PubMed 38588457

  • 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.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality and Exercise Therapy in people with Parkinson Disease and Virtual Reality Therapy, run by Farzin Hajebrahimi, PT, MSc at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: due to COVID-19 outbreak). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Level (time frame: Change from Baseline at 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637023, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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