The DriveSim clinical trial investigates a dynamic driving simulator designed to train and assess functional motor and cognitive skills in individuals with neurological disorders. The study addresses a critical need in current rehabilitation practice, where maintaining patient engagement and providing ecologically valid training environments are essential yet challenging. Neurological conditions such as stroke, Parkinson's disease, amyotrophic lateral sclerosis and mild cognitive impairment often result in deficits in balance, proprioception, coordination, attention and motor planning, all of which critically affect daily functioning and driving ability. The novelty of this study lies in the integration of a three-degree-of-freedom motion platform with active steering, customizable haptic and inertial feedback, and adaptive task modules in a virtual urban scenario. This enables controlled, multisensory rehabilitation sessions that combine motor, vestibular and cognitive stimuli in a single system. The primary objective of the trial is to evaluate the safety, usability and feasibility of the DriveSim platform in both healthy individuals and patients with neurological impairment. Secondary objectives include assessing its impact on postural control, trunk and head stability, upper and lower limb motor performance, cognitive functions, perceived stress and fatigue, and quality of life. The study also aims to support the development of adaptive software capable of automatically adjusting task difficulty based on patient performance. By integrating functional tasks such as slalom, speed control, line keeping and reaction tests with customizable sensory feedback, this research has the potential to enhance the ecological validity of rehabilitation and to provide individualized motor-cognitive training. The expected outcome is a more engaging, adaptable and measurable rehabilitation pathway that may improve functional independence and support safer driving-related abilities in neurological populations.
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Evaluation of System Usability Scale (SUS)
Timeframe: Session 12 (end of treatment, Week 4)
Incidence of device-related adverse events
Timeframe: From Session 2 through Session 12 (up to 4 weeks)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) mean total score
Timeframe: End of treatment (Session 12, Week 4)
Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) usability score
Timeframe: End of treatment (Session 12, Week 4).
State-Trait Anxiety Inventory (STAI) state and trait anxiety scores
Timeframe: Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)
Perceived Stress Scale (PSS)
Timeframe: Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).