Comparing the effects of augmented virtual reality treadmill training versus conventional treadmill training in patients with stage II-III Parkinson's disease: the VIRTREAD-PD randomized controlled trial protocol

This is the study protocol of a single-center, randomized controlled single-blind trial comparing treadmill training (TT) with augmented virtual reality (AVR) application with conventional TT in II-III stage PD patients suffering from gait disturbances. The primary aim of this study is to compare the effects on gait performances of TT + AVR versus TT alone in II-III stage PD patients with gait disturbance. Secondary aims are to assess the effects on balance, gait parameters and other motor and non-motor symptoms, and patient's satisfaction and adherence to the treatment. As an exploratory aim, the study attempts to identify biomarkers of neuroplasticity detecting changes in Neurofilament Light Chain concentration T0-T1 and to identify prognostic biomarkers associated to blood-derived Extracellular Vesicles. This study will provide data on the possible superiority of AVR-associated treadmill training (TT) over conventional TT in improving gait and other motor and non-motor symptoms in persons with PD and gait disturbances. The results of the exploratory analysis could add information in the field of biomarker research in PD rehabilitation