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NCT07539272

Device for Driving Simulation for the Rehabilitation of Balance and Proprioception

Sponsor: University of Pavia

View on ClinicalTrials.gov

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.

Official title: A Multicenter Interventional Study on the Use of a Driving Simulator to Assess the Safety and Usability of the System and Its Impact on Motor and Cognitive Performance in the Rehabilitation of Patients With Neurological Disorders

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2026-11

Last Updated

2026-04-20

Healthy Volunteers

Yes

Conditions

Neurological Disorders Health Adult Subjects

Interventions

DEVICE

DriveSim Rehab

DriveSim Rehab is a driving simulator for cognitive rehabilitation and recovery of driving-related abilities. The system includes a dynamic platform with three degrees of freedom (roll, pitch, and vertical translation), an active steering system with torque feedback, pedals, seat, monitor or virtual reality headset, digital control station, and emergency stop buttons. The software allows urban driving-based tasks and adjustable interaction parameters.

OTHER

Conventional Rehabilitation

Traditional rehabilitative treatment delivered according to usual clinical practice at the participating centers. Participants undergo 12 sessions of at least 30 minutes each, three times per week.

Inclusion Criteria: * Patients: adults aged 18 to 80 years. * Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI). * Patients: able to understand and follow study procedures and provide informed consent. * Healthy volunteers: adults aged 18 to 65 years. * Healthy volunteers: able to understand and follow study procedures and provide informed consent. * Healthy volunteers: rehabilitation staff members from the participating centers. Exclusion Criteria: * Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires. * Patients: unable to provide informed consent. * Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment. * Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale. * Patients: body weight greater than 100 kg. * Patients: current or recent participation, within the last 3 months, in other rehabilitation programs or interventions that could affect study results. * Patients: alcohol or substance dependence that could compromise safety during training sessions. * Patients: unstable health conditions that could make use of the DRIVESIM and/or head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions. * Healthy volunteers: health conditions that could make use of the DRIVESIM and/or head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions. * Healthy volunteers: any motor disability.