Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pavia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DriveSim Rehab
DeviceDriveSim 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.
Conventional Rehabilitation
Other interventionTraditional 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Robotic Treatment GroupActive comparator 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of System Usability Scale (SUS)
System usability assessed with the System Usability Scale (SUS), a 10-item questionnaire using 5-point Likert responses to evaluate perceived usability of the device. The total score ranges from 0 to 100, with higher scores indicating better perceived usability.
Time frame
Session 12 (end of treatment, Week 4)2
Incidence of device-related adverse events
Incidence defined as the number of participants with at least 1 device-related adverse event during the treatment period. Device-related adverse events reported by the participant or detected by the operator will be recorded on an ad hoc case report form at the end of each device-use session.
Time frame
From Session 2 through Session 12 (up to 4 weeks)3
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) mean total score
Satisfaction and feasibility of the DriveSim Rehab system assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), a 12-item questionnaire evaluating satisfaction with the assistive device and related services using a 5-point scale. Mean total score ranges from 1 to 5, with higher scores indicating greater satisfaction.
Time frame
End of treatment (Session 12, Week 4)4
Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) usability score
Patient perception of technology-assisted rehabilitation assessed using the Usability domain of the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The Usability domain includes 5 items scored on a 4-point Likert scale; total score ranges from 5 to 20, with higher scores indicating better perceived usability.
Time frame
End of treatment (Session 12, Week 4).Secondary outcomes
1
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item clinical scale used to assess balance and postural stability. Each item is scored from 0 to 4, corresponding to a total score range of 0 to 56; higher scores indicate better balance performance.
Time frame
Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).2
Timed Up and Go (TUG)
The Timed Up and Go test measures the time required for a participant to stand up from a chair, walk 3 meters, turn around a marker, walk back, and sit down. Lower completion time indicates better functional mobility and balance.
Time frame
Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)3
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test is used to assess walking endurance and functional walking capacity. Greater walking distance indicates better walking performance.
Time frame
Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)4
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test measures walking speed over a distance of 10 meters and is used to assess mobility. Higher walking speed indicates better mobility performance.
Time frame
Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pavia
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Source ClinicalTrials.gov
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