Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the feasibility, safety and efficacy of an immersive virtual reality (IVR) exergaming using a head-mounted display in Parkinson's disease symptomatic control. This is a parallel-group, single-blinded, randomized controlled trial. The intervention group perform 12 weeks of physiotherapy and IVR, whereas the control group have 6 weeks of physiotherapy only, followed by 6 weeks of physiotherapy and IVR. The primary outcome is the symptomatic effect of the intervention as measured by the change from baseline in Time Up and Go (TUG) test with cognitive dual-task (TUG cognitive).

Official Title
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Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: HTC Vive™ Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with Parkinson's disease according to MDS criteria; Hoehn and Yahr stages between I-III (MED ON); Ability to perform the Time Up and Go test in normal pace and without assistance, in less than 11,5 seconds in ON state; Stable medication for the past 1 month; Ability to communicate with the investigator, to understand and comply with the requirements of the study; Able to provide written informed consent to participate in the study. Exclusion Criteria: Postural instability or freezing of gait in MED ON representing an increased risk of fall, according to the best clinical judgement; A Montreal Cognitive Assessment (MoCA) score < 21; Presence of severe visual loss that could interfere with the ability to see the VR simulation as well as vertigo, epilepsy and psychosis; Unstable medical condition, including cardiovascular, pulmonary or musculoskeletal, that according to the clinician's judgment affect patients' ability to participate in the study; Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR group<br>12 consecutive weeks of physiotherapy + training with the IVR | Device: HTC Vive™ Pro<br>* A commercially available head-mounted display. Each VR session has approximately 20 minutes, performed 3 times per week. Both groups maintain similar PD specialized physiotherapy sessions throughout the duration of the study (3 times per week, 60 minutes per session).<br>|
| Active Comparator: Active control group<br>6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR | Device: HTC Vive™ Pro<br>* A commercially available head-mounted display. Each VR session has approximately 20 minutes, performed 3 times per week. Both groups maintain similar PD specialized physiotherapy sessions throughout the duration of the study (3 times per week, 60 minutes per session).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6-week in TUG cognitive test | Change from baseline to 6-week in TUG cognitive test | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking | Difference between groups in change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Difference between groups in change from baseline to each evaluation time point in MDS-UPDRS | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test) | Difference between groups in change from baseline to each evaluation time point in mini-BEST test | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA) | Difference between groups in change from baseline to each evaluation time point in MoCA | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Stroop test | Difference between groups in change from baseline to each evaluation time point in Stroop test | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters) | Difference between groups in change from baseline to each evaluation time point in VOSP-cube analysis and VOSP-fragmented letters | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39) | Difference between groups in change from baseline to each evaluation time point in PDQ-39 score | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Schwab and England (S&E) scale | Difference between groups in change from baseline to each evaluation time point in S&E scale | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity | Difference between groups in change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity | 6, 12 and 16 weeks | 
| Change from baseline to each evaluation time point in BMI | Difference between groups in change from baseline to each evaluation time point in BMI | 6, 12 and 16 weeks | 
| Occurrence of adverse events | Difference between groups in patient's safety | 16 weeks | 
| Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ) | Difference between groups in SSQ | 16 weeks | 
| Patients' consideration on system usability using the System Usability Scale (SUS) | SUS after the 1st week using the IVR system and at each evaluation time point | 1, 6, 12 and 16 weeks | 
| Patients' Borg perceived exertion | Difference between groups in perceived exertion | 16 weeks | 
| Likert scale on patients' satisfaction using the virtual reality system | Difference between groups in patients' satisfaction | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immersive virtual reality, Neurorehabilitation