Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
Starting soon · Not applicable
Conditions studied: Neurological Disorders, Health Adult Subjects
In brief
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.
Key facts
- Study ID
- NCT07539272
- Run by
- University of Pavia
- People needed
- 60
- Starts
- 2026-04-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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