Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-11-17
2029-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Right hemisphere stroke
Participants with a history of a unilateral stroke affecting the right cerebral hemisphere.
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
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.
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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 severe psychiatric illness (e.g., schizophrenia or other psychotic disorders)
* Recent substance abuse/dependence disorder (\< 1 year)
* Non-Veteran status
40 Years
80 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Krista Schendel Parker, PhD BA
Role: PRINCIPAL_INVESTIGATOR
VA Northern California Health Care System, Mather, CA
Locations
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VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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N5300-R
Identifier Type: -
Identifier Source: org_study_id
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