Device for Driving Simulation for the Rehabilitation of Balance and Proprioception (DRIVESIM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurological Disorders; Health Adult Subjects
• Intervention / Treatment: Other: Conventional Rehabilitation; Device: DriveSim Rehab

Detailed Description

Neurological conditions such as stroke, Parkinson's disease, amyotrophic lateral sclerosis and mild cognitive impairment are among the leading causes of long-term disability worldwide. These disorders profoundly affect motor coordination, postural stability, sensory integration, executive function and attention, with direct consequences on daily activities and overall independence. In current healthcare practice, rehabilitation is essential to maintain or recover functional abilities, but traditional interventions often lack ecological validity, offer limited multisensory stimulation and rely on repetitive, non-engaging exercises. As a result, there is a growing need for innovative rehabilitation tools capable of delivering realistic, quantifiable and cognitively stimulating training. State-of-the-art rehabilitation increasingly integrates technology to enhance patient interaction, measure performance and personalize the training load. Despite this progress, most existing systems do not combine dynamic body perturbation, interactive cognitive tasks and functional motor activities within a controllable scenario. Multisensory integration, which is essential for safe mobility and driving-related functions, remains insufficiently addressed in conventional therapy. This limitation is particularly evident when training tasks that require simultaneous postural control, visuospatial skills, rapid reaction, decision-making and coordinated use of upper and lower limbs.

The DriveSim Rehab platform was conceived to fill this gap by providing a dynamic three-degree-of-freedom driving simulator equipped with active steering, configurable inertial feedback and a customizable virtual urban environment. Its multisensory nature enables the delivery of controlled proprioceptive, visual and motor challenges that mirror real-world demands while maintaining a safe clinical setting. This approach supports a more engaging and functionally meaningful form of rehabilitation, while enabling precise quantitative monitoring of motor and cognitive performance. The rationale of the study is to evaluate whether DriveSim Rehab can be safely and effectively integrated into rehabilitation pathways for individuals with neurological disorders. The primary objective is to assess the safety, usability and feasibility of the system during its use both in healthy subjects and in patients affected by stroke, Parkinson's disease, amyotrophic lateral sclerosis and mild cognitive impairment. These parameters are essential to determine whether the technology can be introduced into routine clinical practice without risk and with adequate user acceptance. Secondary objectives aim to determine the potential rehabilitative value of the platform. Specifically, the study evaluates its impact on head and trunk control, upper and lower limb motor performance, cognitive functions (including attention, visuospatial abilities and executive functions), perceived stress and fatigue, and quality of life. Additionally, the study supports the creation and validation of adaptive software capable of automatically adjusting task difficulty based on real-time patient performance, with the goal of personalizing treatment intensity and maximizing therapeutic efficacy. By integrating dynamic proprioceptive stimulation, interactive cognitive tasks and functional motor actions within a realistic driving simulation, DriveSim Rehab offers a novel rehabilitative paradigm that could significantly enhance patient engagement and functional outcomes. Its implementation in clinical practice has the potential to support greater independence, improve multisensory integration and provide clinicians with objective metrics to optimize rehabilitation strategies in neurological populations.

METHODS The study is designed as a single-group, multicenter interventional clinical investigation aimed at evaluating the safety, usability and feasibility of the DriveSim Rehab platform in both healthy subjects and individuals with neurological disorders. According to the protocol, the study includes a total sample of 60 participants: 20 healthy volunteers and 40 patients diagnosed with stroke, Parkinson's disease, amyotrophic lateral sclerosis or mild cognitive impairment. All participants undergo a structured assessment and a predefined sequence of rehabilitation exercises using the DriveSim system within a controlled clinical environment. Since the study does not involve comparison with a control group or the use of blinding, all participants receive the same intervention. The treatment consists of a set of functional driving-related tasks performed on the DriveSim dynamic simulator, which integrates a three-degree-of-freedom motion platform, active steering, inertial feedback and an immersive virtual urban scenario. Exercises include slalom, line keeping, obstacle avoidance, reaction-time tasks, speed modulation, head and trunk control challenges, upper-limb steering tasks and coordinated lower-limb movements. Each session also enables collection of kinematic and cognitive performance indicators through instrumented software modules.

The primary endpoints include safety (absence of adverse events or technical issues), feasibility (ability to complete the protocol) and usability (participant-reported experience). Secondary endpoints assess performance in postural control, trunk and head stability, limb motor execution, cognitive tasks (attention, visuospatial function and executive components), perceived stress and fatigue, and health-related quality of life. The protocol specifies the use of descriptive statistics and comparative analyses across sessions to quantify performance changes and to evaluate consistency, reaction times and variability in kinematic measures.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Nardone, PhD; Phone Number: 0382592693; Email: antonio.nardone@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; Participants receive conventional rehabilitation only, according to usual clinical practice. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week.	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.
Active Comparator: Robotic Treatment Group; Participants receive conventional rehabilitation plus training with the DriveSim Rehab device. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week, according to usual clinical practice. Participants in this group additionally receive DriveSim Rehab sessions of up to 15 minutes each under therapist supervision.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Session 12 (end of treatment, Week 4)
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.	From Session 2 through Session 12 (up to 4 weeks)
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.	End of treatment (Session 12, Week 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.	End of treatment (Session 12, Week 4).
State-Trait Anxiety Inventory (STAI) state and trait anxiety scores	Anxiety levels assessed with the State-Trait Anxiety Inventory (STAI), a self-reported questionnaire that measures both state anxiety and trait anxiety. The State Anxiety and Trait Anxiety subscale scores each range from 20 to 80, with higher scores indicating greater anxiety.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)
Perceived Stress Scale (PSS)	Perceived stress assessed with the Perceived Stress Scale (PSS), a self-reported questionnaire used to evaluate the extent to which life situations are experienced as unpredictable, uncontrollable, and overwhelming. Total score ranges from 0 to 40, with higher scores indicating greater perceived stress.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
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.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)
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.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 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.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Fugl-Meyer Assessment (FMA)	The Fugl-Meyer Assessment evaluates motor, sensory, and balance function in individuals with stroke or brain lesions.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Psychosocial Impact of Assistive Devices Scale (PIADS) mean total score	Psychosocial impact of the DriveSim Rehab system assessed with the Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item questionnaire evaluating competence, adaptability, and self-esteem. Mean total score ranges from -3 to +3, with higher scores indicating a more positive psychosocial impact of the device.	End of treatment (Session 12, Week 4).
EuroQol 5-Dimension (EQ-5D) visual analogue scale (EQ VAS) score	Health-related quality of life assessed with the EuroQol 5-Dimension (EQ-5D) questionnaire, including the EQ visual analogue scale (EQ VAS) for current health perception. EQ VAS score ranges from 0 to 100, with higher scores indicating better perceived health status.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Trail Making Test Part A	Trail Making Test Part A assesses attention, concentration, and executive processing speed by requiring the participant to connect consecutive numbers as quickly as possible. Lower completion time indicates better performance.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Stroop Test	The Stroop Test assesses concentration and cognitive flexibility by requiring the participant to name the ink color of printed words while inhibiting the automatic reading response.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Digit Span Test	The Digit Span Test assesses working memory and attention by requiring the participant to repeat sequences of numbers.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Mean driving speed during simulator tasks	Mean driving speed recorded by the simulator during driving tasks, used as an objective measure of speed control performance in participants exposed to DriveSim Rehab.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Number of collisions and/or proximity events during simulator tasks	Number of collisions and/or proximity events recorded by the simulator during driving tasks, used as an objective measure of driving performance and environmental interaction. Lower values indicate better performance.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Lane deviation during simulator tasks	Lane deviation recorded by the simulator during driving tasks, used as an objective measure of lane-keeping ability. Lower deviation indicates better driving control.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).
Reaction time to simulated obstacles	Reaction time recorded by the simulator as the time elapsed between the appearance of an obstacle and the participant's response using the steering wheel or brake. Lower reaction time indicates better performance.	Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).

Collaborators and Investigators

• Sponsor: University of Pavia
• Collaborators: Istituti Clinici Scientifici Maugeri SpA

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: neurological rehabilitation; motor-cognitive training; driving simulator; dynamic platform
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: CTSPV26-24 - CTSM140-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No