Device for Driving Simulation for the Rehabilitation of Balance and Proprioception

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.

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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• University of Pavia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2026-09-30

Completion

2026-11-30