Campus Neurológico Sénior
Torres Vedras, 2560-280, Portugal
NCT Number: NCT04699617
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Torres Vedras, 2560-280, Portugal
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 frame: 6-weeks (T1)
Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks
Time frame: 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
Time frame: Baseline, 6-week, 12-week and 16-week
Difference between groups in MDS-UPDRS
Time frame: Baseline, 6-week, 12-week and 16-week
Difference between groups in Mini-best test
Time frame: at baseline and 16-week
Difference between groups in SCOPA-Cog
Time frame: at baseline and and 12-week
Difference between groups in PDQ-39 score
Time frame: Baseline, 6-week, 12-week and 16-week
Difference between groups in Clinical Global Improvement
Time frame: Baseline, 6-week, 12-week and 16-week
Difference between groups in Patient Global Impression - Change
Time frame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks
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
Difference between groups in Simulator Sickness Questionnaire
Time frame: 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 frame: 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 frame: Baseline, 6-week, 12-week and 16-week
Difference between groups in BMI
Time frame: at baseline and 12-week
Difference between groups in Schwab and England scale
Time frame: 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)
Campus Neurológico Sénior
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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