This multicenter interventional study aims to evaluate a three-degrees-of-freedom dynamic platform (3DoF Platform) designed to support rehabilitation of balance, proprioception, and motor and cognitive functions in patients with neurological disorders. The device integrates a mobile platform capable of roll, pitch, and vertical translation movements, a markerless motion-capture system, and an interactive environment delivered through a monitor or virtual reality headset. Compared with conventional rehabilitation systems, it offers an additional vertical degree of freedom and increased proprioceptive stimulation, with the ability to customize exercises according to individual patient capabilities. The clinical conditions under investigation include Parkinson's disease, post-stroke motor impairment, amyotrophic lateral sclerosis, and mild cognitive impairment, all of which are associated with deficits in balance and proprioception. The novelty of this study lies in the combined use of the 3DoF platform, the markerless acquisition system, and exergames integrated with a mathematical model that adapts the platform's dynamic response in real time. The primary objective is to assess the usability, feasibility, and safety of the device. Secondary objectives include evaluating the impact of the intervention on balance, motor performance, cognitive functions, stress, fatigue, and quality of life, as well as comparing conventional rehabilitation with and without the addition of the device. The study involves 45 patients and 15 healthy volunteers and is structured into an initial phase of testing on healthy subjects and a subsequent randomized two-arm treatment phase for patients.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of Adverse Events
Timeframe: From the first session to the end of the intervention, up to 4 weeks
Evaluation of System Usability Scale (SUS)
Timeframe: Session 12 (final evaluation, Week 4).
Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0
Timeframe: Session 12 (final evaluation, Week 4).
Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire
Timeframe: Session 12 (final evaluation, Week 4).
Change from baseline in State-Trait Anxiety Inventory
Timeframe: Baseline (Session 1) and Session 12 (final evaluation, Week 4)
Change From Baseline in Perceived Stress Scale (PSS)
Timeframe: Baseline (Session 1) and Session 12 (final evaluation, Week 4)