Parkinson Disease
Conditions
Brief summary
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.
Interventions
DEVICEDolphin 2.0
The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.
Sponsors
Johns Hopkins University
Campus Neurológico Sénior
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single-blind (blind rater for primary and secondary outcomes)
Intervention model description
A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect) | 6-weeks (T1) | Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in MDS-UPDRS | Baseline, 6-week, 12-week and 16-week | Difference between groups in MDS-UPDRS |
| Change in Mini-best test | Baseline, 6-week, 12-week and 16-week | Difference between groups in Mini-best test |
| Change in SCOPA-Cog | at baseline and 16-week | Difference between groups in SCOPA-Cog |
| Change in PDQ-39 score | at baseline and and 12-week | Difference between groups in PDQ-39 score |
| Change in Clinical Global Improvement | Baseline, 6-week, 12-week and 16-week | Difference between groups in Clinical Global Improvement |
| Change in Patient Global Impression - Change | Baseline, 6-week, 12-week and 16-week | Difference between groups in Patient Global Impression - Change |
| Time reduction in seconds in the TUG test (late intervention effect) | 12-weeks (T2) and 16-weeks (T3) | Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks |
| Simulator Sickness Questionnaire | after the 1st session of 1st week and the last sessions of 6th and 12th weeks | Difference between groups in Simulator Sickness Questionnaire |
| Number of steps/day | Baseline, 6-week, 12-week and 16-week | Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity) |
| Time spent in each level of activity | Baseline, 6-week, 12-week and 16-week | Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity) |
| Change in BMI | Baseline, 6-week, 12-week and 16-week | Difference between groups in BMI |
| Change in Schwab and England scale | at baseline and 12-week | Difference between groups in Schwab and England scale |
| Patients' satisfaction and perceived exertion | after the 1st session of 1st week and the last sessions of 6th and 12th weeks | Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale) |
| System Usability Scale | after the 1st session of 1st week and the last sessions of 6th and 12th weeks | Difference between groups in System Usability Scale |
Countries
Portugal
Outcome results
None listed