BACKGROUND: Exergaming is a new technology for implementing innovative rehabilitation interventions for neurological conditions. Our aim was to evaluate the feasibility, safety and efficacy of a novel exergaming experience called neuroanimation, in the form of MindPodTM Dolphin, added to an intensive physiotherapy program for Parkinson's disease (PD). METHODS: MindPod Dolphin provides a 2D oceanic environment where patients make high-amplitude 3D arm movements controlling an animated dolphin. We conducted a rater-blinded, randomized-controlled trial. Eligible people with PD were assigned into two groups: MindPod Dolphin over 12-weeks combined with physiotherapy (COM) or sequentially after 6-weeks of physiotherapy alone (SEQ). Sessions occurred three times/week. Assessments occurred at baseline, 6-week, 12-week, and 4-week post-intervention. The primary outcome was change from baseline to 6-week in the Timed Up and Go (TUG) test. Secondary outcomes were change, from baseline to each evaluation timepoint, in several motor, cognitive and quality of life measures. Participants ' safety was assessed. Adherence, system usability and participants' satisfaction were used as measures of feasibility. RESULTS: Thirty individuals were recruited. Baseline characteristics were similar between groups. Our primary outcome (change in TUG from baseline to 6-week) did not significantly differ between groups (median TUG change in COM 0.243 (-1.873 to 1.176) versus SEQ -0.016 (-0.810 to 0.350), estimated difference 0.002 (95% CI -1.103 to 1.273); p = 0.983). Both groups improved in motor and cognitive measures with a trend favoring COM. When compared to SEQ, COM improved significantly in TUG cognitive from baseline to 16-week (p = 0.048). A main effect of time was observed for TUG cognitive in COM, and mini-BEST in SEQ. Adverse events (n = 309) were mostly mild (55%). Overall, 20 participants (67%) adhered to the study protocol, with the COM being more compliant than the SEQ group. MindPod Dolphin was considered easy to use and over 80% of participants were at least moderately satisfied with it as an intervention. CONCLUSIONS: Neuroanimation-based exergaming in PD was feasible, safe and effective in improving multiple secondary measures. The advantages of the exergame became evident at 12-weeks and beyond, suggesting that it had cumulative and delayed beneficial effects on cognitive and motor outcomes when added to a lead-in phase of intense physiotherapy. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT04699617.

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