A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.

Neurological conditions such as stroke, Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS) and mild cognitive impairment (MCI) frequently impair balance and proprioception through combined central and peripheral mechanisms. Alterations in muscle spindles, joint mechanoreceptors and cortical grey matter volumes compromise postural control, coordination and the ability to adapt movements without continuous visual feedback. These deficits lead to gait instability, increased risk of falls, traumatic injuries, loss of independence and high healthcare utilisation, especially in ageing populations where multimorbidity and frailty are prevalent. In this context, interventions that can effectively target balance and proprioceptive dysfunction are highly relevant to current healthcare challenges, which include reducing fall-related hospitalisations, supporting safe community living and improving quality of life in people with chronic neurological disease. Conventional neurorehabilitation relies on therapist-guided balance exercises, overground or treadmill gait training and task-oriented activities. These approaches are effective but often limited by the intensity and variability that can be delivered in routine practice, and by the scarcity of objective kinematic data to guide personalised progression. Robotic and moving-platform systems used in research settings have shown that perturbation-based and task-specific balance training can improve postural responses, gait and falls risk in several neurological populations, yet many commercial devices offer only two degrees of freedom and restricted ranges of motion. Evidence on the integration of immersive exergames and virtual reality (VR) into balance training suggests benefits in engagement and cognitive-motor stimulation, but existing technologies are frequently non-adaptive, do not exploit full-body motion capture, and have been evaluated mainly in small, single-pathology cohorts. There remains a gap for multifunctional systems that combine multi-axis mechanical perturbations, markerless motion analysis and immersive exergames, and that are systematically tested in diverse neurological conditions within real clinical workflows. The 3DoF Platform has been developed from a sports-performance motion platform into a device specifically tailored for neurorehabilitation. It provides controlled roll, pitch and vertical translation, coupled with a markerless motion capture system that estimates the position of key body segments and the centre of mass in real time. By linking these kinematic data to an adaptive control model and VR-based exergames, the platform can deliver graded and repeatable balance challenges while maintaining patient safety through harness support and strict software limits on speed and amplitude. The rationale of the present study is to (a) verify that this non-CE-marked device can be used safely and feasibly in routine rehabilitation settings, (b) assess its usability and acceptability for both patients and staff, and (c) explore whether adding 3DoF Platform training to conventional therapy yields measurable benefits on balance, motor performance, cognition, fatigue, stress and quality of life across different neurological conditions. The central hypothesis is that the 3DoF Platform can be safely integrated into multidisciplinary neurorehabilitation pathways, is acceptable and usable for patients and clinicians, and, when combined with standard therapy, leads to superior improvements in balance, proprioception and functional outcomes compared with standard therapy alone.

Primary objectives:

• To assess safety for patients and operators by monitoring adverse events and system errors during all sessions.
• To evaluate usability and feasibility of the device using validated questionnaires and patient-reported measures of stress, anxiety and user experience.

Secondary objectives:

• To quantify the impact of 3DoF Platform training on balance, gait and motor performance using established clinical scales and instrumented markerless measures.
• To assess changes in cognitive performance, perceived fatigue, psychosocial impact and health-related quality of life.
• To compare outcomes between patients receiving conventional rehabilitation plus 3DoF Platform and those receiving conventional rehabilitation alone.
• To develop and validate adaptive software modules that automatically adjust exercise difficulty based on real-time movement analysis.