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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Experimental | 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. |
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| Delayed-start control arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolphin 2.0 | Device | The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures. |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquim Ferreira, MD,PhD | CNS - Campus Neurológico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Neurológico Sénior | Torres Vedras | 2560-280 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40500714 | Derived | Pimenta Silva D, Bouca-Machado R, Pona-Ferreira F, Lobo T, Cacho R, Anker R, Krakauer JW, Ferreira JJ. Combining immersive exergaming with physiotherapy in a specialized intensive Parkinson's disease rehabilitation program: a randomized controlled trial. J Neuroeng Rehabil. 2025 Jun 11;22(1):131. doi: 10.1186/s12984-025-01640-w. | |
| 38588457 |
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The methodology followed and the results of the study will be shared at the end through publication in a peer-review journal
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
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single-blind (blind rater for primary and secondary outcomes)
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 |
| 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. |
| 36602886 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |