Device for Driving Simulation for the Rehabilitation of Balance and Proprioception

NCT07539272 | Not Yet Recruiting

• 1 other identifier: CTSPV26-24 - CTSM140-24
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

neurological rehabilitation; driving simulator; dynamic platform; motor-cognitive training

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• Berg Balance Scale (BBS)

  Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).

• Timed Up and Go (TUG)

  Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)

• 6-Minute Walk Test (6MWT)

  Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4)

• 10-Meter Walk Test (10MWT)

  Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).

• Fugl-Meyer Assessment (FMA)

  Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4).

Study Arms (2)

Robotic Treatment Group

ACTIVE COMPARATOR

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

Control Group

OTHER

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

Interventions

DriveSim Rehab DEVICE

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.

Robotic Treatment Group

Conventional Rehabilitation OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pavia: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

MeSH Terms

Conditions

Nervous System Diseases

Central Study Contacts

Antonio Nardone, PhD

CONTACT

0382592693; antonio.nardone@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share