Clinical Trial

Device for Driving Simulation for the Rehabilitation of Balance and Proprioception

Study acronym: DRIVESIM
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07539272
Lead Sponsor University of Pavia
Collaborators: Istituti Clinici Scientifici Maugeri SpA
Conditions Neurological Disorders, Health Adult Subjects
Enrollment 60 participants
Start Date 2026-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-20