Driver Simulator Training to Improve Driving After Stroke

Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients

One hundred Veteran stroke survivors will participate in both an Active Driver Training intervention and a Control intervention in a fully interactive driving simulator. In addition, all participants will complete pre- and post-intervention driving assessments in the driving simulator to measure driving performance and types of driving errors committed. Half the participants will receive the Active Driver Training first, whereas the other half will receive the Control intervention first. Each Active Driver Training session will provide targeted practice and feedback on each of four unique driving skills including: speed management, collision avoidance, lane positioning, and dashboard attention. The Control intervention will be matched for total time but will only provide extra familiarization with the operation of the driving simulator, with no skill-specific practice. It is predicted that the Active Driver Training Intervention will result in improved driving performance, relative to the Control condition. In addition, after a delay period of at least 6 months, all participants will be re-assessed in the driving simulator and will complete a survey to capture changes in driving status.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Active Driver Training Intervention; Behavioral: Control Intervention

Detailed Description

In this study, 100 Veteran stroke survivors (half with left hemisphere stroke and half with right hemisphere stroke) will engage in both an Active and a Control simulated driving intervention. The order of interventions (Active first vs. Control first) will be randomly assigned.

Each driving intervention will include weekly training for 3 consecutive weeks, followed by a post-intervention driving assessment. After a 1-week delay, participants will complete the other intervention type (for 3 consecutive weeks) followed by another post-intervention driving assessment. Last, all participants will be re-assessed 6 months later to measure stability of post-intervention driving performance and to complete a questionnaire on current driving status. The driving intervention condition (Active vs. Control) will serve as the main predictor variable in the study.

The Active Driver Training intervention sessions include targeted practice on four critical driving skills, namely, lane positioning, speed management, collision/obstacle avoidance, and dashboard attention. In each driver training session, participants complete all 4 modules sequentially, take a short break, and then repeat the sequence. In other words, participants receive targeted training on each skill six times over the 3-week training period.

In the Control sessions, participants will participate in familiarization drives, for a total duration comparable to the Active Driver Training sessions. The familiarization drive is a pre-programmed feature of the driving simulator that is designed to introduce/familiarize participants with the interactive features of the driving simulator (steering wheel, turn signals, rear-view mirror, etc.) but does not include any complex challenges or situations that require decision-making, and no performance feedback is given.

Simulated driving assessments will be re-administered upon completion of each intervention condition (Active Driver Training vs. Control), and again after a 6-month delay period. The driving assessments involve a challenging drive with multiple speed changes and obstacles and provides an overall score, as well as the number of driving errors committed. Post-intervention Driving Assessment scores will provide an indication of driving improvement due to intervention type, thus serving as the primary outcome variable.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Juliana V Baldo, PhD; Phone Number: (925) 372-4649; Email: Juliana.Baldo@va.gov
• Study Contact Backup: Name: Krista S Parker, PhD BA; Phone Number: (925) 372-2513; Email: Krista.Parker@va.gov

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95655-4200
      • Recruiting
      • VA Northern California Health Care System, Mather, CA
      • Contact: Jerry L Nadler, MD; Phone Number: (916) 843-2776; Email: Jerry.Nadler@va.gov
      • Contact: Juliana V Baldo, PhD; Phone Number: (925) 372-4649; Email: Juliana.Baldo@va.gov
      • Sub-Investigator: Juliana V. Baldo, PhD
      • Principal Investigator: Krista Schendel Parker, PhD BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

U.S. Veteran stroke survivors within the VA Northern California Health Care network

Description

Inclusion Criteria:

• U.S. Veterans
• History of a unilateral stroke (at least 3 months post-onset)
• Ages 40-80
• pre-morbidly right hand dominant
• prior driving experience/U.S. driver's license

Exclusion Criteria:

• History of other neurologic illness (e.g., TBI, dementia, epilepsy, Parkinson's, etc.)
• History of severe psychiatric illness (e.g., schizophrenia or other psychotic disorders)
• Recent substance abuse/dependence disorder (< 1 year)
• Non-Veteran status

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right hemisphere stroke; Participants with a history of a unilateral stroke affecting the right cerebral hemisphere.	Behavioral: Active Driver Training Intervention; simulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention; Other Names: Active Training Intervention; Behavioral: Control Intervention; pre-scripted familiarization with driving simulator controls in the absence of any complex driving scenarios, decision making requirements, or feedback pertaining to driving skills
Left hemisphere stroke; Participants with a history of a unilateral stroke affecting the left cerebral hemisphere.	Behavioral: Active Driver Training Intervention; simulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention; Other Names: Active Training Intervention; Behavioral: Control Intervention; pre-scripted familiarization with driving simulator controls in the absence of any complex driving scenarios, decision making requirements, or feedback pertaining to driving skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving Score-post Active Training Intervention	Numerical score generated from the simulated Driving Assessment that takes place after the Active Driver Training intervention.	4 weeks
Driving Score- post Control Intervention	Numerical score generated from the simulated Driving Assessment that takes place after the Control intervention.	4 weeks
6-mo followup Driving Score	Driving Assessment after a 6-mo post-intervention delay	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to Driving Status-6months	Self reported return to driving status	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Krista Schendel Parker, PhD BA, VA Northern California Health Care System, Mather, CA

Publications and helpful links

General Publications

• Akinwuntan AE, Wachtel J, Rosen PN. Driving simulation for evaluation and rehabilitation of driving after stroke. J Stroke Cerebrovasc Dis. 2012 Aug;21(6):478-86. doi: 10.1016/j.jstrokecerebrovasdis.2010.12.001. Epub 2011 Jan 14.
• Devos H, Akinwuntan AE, Nieuwboer A, Truijen S, Tant M, De Weerdt W. Screening for fitness to drive after stroke: a systematic review and meta-analysis. Neurology. 2011 Feb 22;76(8):747-56. doi: 10.1212/WNL.0b013e31820d6300.
• Akinwuntan AE, Devos H, Verheyden G, Baten G, Kiekens C, Feys H, De Weerdt W. Retraining moderately impaired stroke survivors in driving-related visual attention skills. Top Stroke Rehabil. 2010 Sep-Oct;17(5):328-36. doi: 10.1310/tsr1705-328.
• Perrier MJ, Korner-Bitensky N, Petzold A, Mayo N. The risk of motor vehicle crashes and traffic citations post stroke: a structured review. Top Stroke Rehabil. 2010 May-Jun;17(3):191-6. doi: 10.1310/tsr1703-191.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Driving; Cognition; Brain injury
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Brain Injuries
• Other Study ID Numbers: N5300-R

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
• product manufactured in and exported from the U.S.: No