An interventional study of Dolphin 2.0 in Parkinson Disease, sponsored by Campus Neurológico Sénior. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Campus Neurológico Sénior · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Campus Neurológico Sénior is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.
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
Time frame: 6-weeks (T1)
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
Time frame: 12-weeks (T2) and 16-weeks (T3)
Change in MDS-UPDRS
Difference between groups in MDS-UPDRS
Time frame: Baseline, 6-week, 12-week and 16-week
Change in Mini-best test
Difference between groups in Mini-best test
Time frame: Baseline, 6-week, 12-week and 16-week
Change in SCOPA-Cog
Difference between groups in SCOPA-Cog
Time frame: at baseline and 16-week
Change in PDQ-39 score
Difference between groups in PDQ-39 score
Time frame: at baseline and and 12-week
Change in Clinical Global Improvement
Difference between groups in Clinical Global Improvement
Time frame: Baseline, 6-week, 12-week and 16-week
Change in Patient Global Impression - Change
Difference between groups in Patient Global Impression - Change
Time frame: Baseline, 6-week, 12-week and 16-week
System Usability Scale
Difference between groups in System Usability Scale
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6-week, 12-week and 16-week
Change in BMI
Difference between groups in BMI
Time frame: Baseline, 6-week, 12-week and 16-week
Change in Schwab and England scale
Difference between groups in Schwab and England scale
Time frame: at baseline and 12-week
Patients' satisfaction and perceived exertion
Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale)
Time frame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Plan to share: No — The methodology followed and the results of the study will be shared at the end through publication in a peer-review journal
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Campus Neurológico Sénior