The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients

Study Overview
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Brief Summary
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The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures (dolphin, orca, axolotl). Video games lead to high levels of motivation and arousal, provide immediate feedback and playback, provide explicit reward and implicit success, and titrate difficulty levels. This encourages the practice of exercise, being an important complement to physiotherapy sessions. The main goal of this study is to evaluate the feasibility, safety and efficacy of an immersive virtual reality software (Dolphin, 2.0) in Parkinson's disease symptomatic control, in a two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.

Official Title
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The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Dolphin 2.0


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; Willing and able to provide written informed consent to participate in the study. Exclusion Criteria: History of falls (1 fall in the 3 previous months); Psychiatric major co-morbidity (e.g., major depressive disorder as determined by DSM IV criteria); A Montreal Cognitive Assessment (MoCA) score < 21; Significant visual or visual-perceptual deficits or neuropsychological impairments that may limit participation in the protocol; Having any other neurological/orthopaedic disorders likely to affect gait or exercise capacity, e.g., history of stroke; Unstable medical condition including cardiovascular instability in the past 6 months Interfering activities performed at high level (sports); 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: Sequential Assignment
Interventional Model Description: A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active arm<br>The active arm will include 3 days a week of training with the Dolphin 2.0 for 12 consecutive weeks. Each session will have the duration of 60 minutes. | Device: Dolphin 2.0<br>* The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.<br>|
| Active Comparator: Delayed-start control arm<br>The delayed-start control arm will have six-weeks of physiotherapy specialized for PD (3 times/week, 60 minutes/session) and six-weeks of 3 days a week of training with the Dolphin 2.0, with sessions of 60 minutes. | Device: Dolphin 2.0<br>* The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect) | Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks | 6-weeks (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time reduction in seconds in the TUG test (late intervention effect) | Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks | 12-weeks (T2) and 16-weeks (T3) | 
| Change in MDS-UPDRS | Difference between groups in MDS-UPDRS | Baseline, 6-week, 12-week and 16-week | 
| Change in Mini-best test | Difference between groups in Mini-best test | Baseline, 6-week, 12-week and 16-week | 
| Change in SCOPA-Cog | Difference between groups in SCOPA-Cog | at baseline and 16-week | 
| Change in PDQ-39 score | Difference between groups in PDQ-39 score | at baseline and and 12-week | 
| Change in Clinical Global Improvement | Difference between groups in Clinical Global Improvement | Baseline, 6-week, 12-week and 16-week | 
| Change in Patient Global Impression - Change | Difference between groups in Patient Global Impression - Change | Baseline, 6-week, 12-week and 16-week | 
| System Usability Scale | Difference between groups in System Usability Scale | after the 1st session of 1st week and the last sessions of 6th and 12th weeks | 
| Simulator Sickness Questionnaire | Difference between groups in Simulator Sickness Questionnaire | after the 1st session of 1st week and the last sessions of 6th and 12th weeks | 
| Number of steps/day | Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity) | Baseline, 6-week, 12-week and 16-week | 
| Time spent in each level of activity | Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity) | Baseline, 6-week, 12-week and 16-week | 
| Change in BMI | Difference between groups in BMI | Baseline, 6-week, 12-week and 16-week | 
| Change in Schwab and England scale | Difference between groups in Schwab and England scale | at baseline and 12-week | 
| Patients' satisfaction and perceived exertion | Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale) | after the 1st session of 1st week and the last sessions of 6th and 12th weeks |