Driver Simulator Training to Improve Driving After Stroke

NCT06672107 | Recruiting

• 1 other identifier: N5300-R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Brain injury; Driving; Cognition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Return to Driving Status-6months

  6 months

Study Arms (2)

Right hemisphere stroke

Participants with a history of a unilateral stroke affecting the right cerebral hemisphere.

Behavioral: Active Driver Training Intervention; Behavioral: Control Intervention

Left hemisphere stroke

Participants with a history of a unilateral stroke affecting the left cerebral hemisphere.

Behavioral: Active Driver Training Intervention; Behavioral: Control Intervention

Interventions

Active Driver Training Intervention BEHAVIORAL

simulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention

Also known as: Active Training Intervention

Left hemisphere stroke; Right hemisphere stroke

Control Intervention BEHAVIORAL

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; Right hemisphere stroke

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655-4200, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

no biospecimens

MeSH Terms

Conditions

Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Krista Schendel Parker, PhD BA

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krista S Parker, PhD BA

CONTACT

(925) 372-2513; Krista.Parker@va.gov

Juliana V Baldo, PhD

CONTACT

(925) 372-4649; Juliana.Baldo@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)