[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06672107":3,"trial-entities:NCT06672107":115,"trial-summary:NCT06672107":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":56,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":76,"locations":79,"central_contacts":105,"overall_officials":111,"references":113,"see_also_links":114},"NCT06672107","N5300-R","Driver Simulator Training to Improve Driving After Stroke","Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients","RECRUITING","2029-09-30","2026-04","2026-04-24","2025-11-17","VA Office of Research and Development","FED",false,"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.","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.\n\nEach 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.\n\nThe Active Driver Training intervention sessions include targeted practice on four critical driving skills, namely, lane positioning, speed management, collision\u002Fobstacle 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.\n\nIn 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\u002Ffamiliarize 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.\n\nSimulated 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.",[19],"Stroke",[19,21,22,23],"Brain injury","Driving","Cognition","OBSERVATIONAL",null,[],{"count":28,"type":29},100,"ESTIMATED",[31,40],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"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",[36,37],"Left hemisphere stroke","Right hemisphere stroke",[39],"Active Training Intervention",{"type":32,"name":41,"description":42,"armGroupLabels":43},"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",[36,37],[45,49,52],{"measure":46,"description":47,"timeFrame":48},"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",{"measure":50,"description":51,"timeFrame":48},"Driving Score- post Control Intervention","Numerical score generated from the simulated Driving Assessment that takes place after the Control intervention.",{"measure":53,"description":54,"timeFrame":55},"6-mo followup Driving Score","Driving Assessment after a 6-mo post-intervention delay","6 months",[57],{"measure":58,"description":59,"timeFrame":55},"Return to Driving Status-6months","Self reported return to driving status","ALL","40 Years","80 Years",{"inclusion":64,"exclusion":70,"raw_text":75},[65,66,67,68,69],"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\u002FU.S. driver's license",[71,72,73,74],"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\u002Fdependence disorder (\\\u003C 1 year)","Non-Veteran status","Inclusion Criteria:\n\n* U.S. Veterans\n* History of a unilateral stroke (at least 3 months post-onset)\n* Ages 40-80\n* pre-morbidly right hand dominant\n* prior driving experience\u002FU.S. driver's license\n\nExclusion Criteria:\n\n* History of other neurologic illness (e.g., TBI, dementia, epilepsy, Parkinson's, etc.)\n* History of severe psychiatric illness (e.g., schizophrenia or other psychotic disorders)\n* Recent substance abuse\u002Fdependence disorder (\\\u003C 1 year)\n* Non-Veteran status",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":102},"VA Northern California Health Care System, Mather, CA","Sacramento","California","95655-4200","United States",[87,92,96,99],{"name":88,"role":89,"phone":90,"email":91},"Jerry L Nadler, MD","CONTACT","(916) 843-2776","Jerry.Nadler@va.gov",{"name":93,"role":89,"phone":94,"email":95},"Juliana V Baldo, PhD","(925) 372-4649","Juliana.Baldo@va.gov",{"name":97,"role":98},"Juliana V. Baldo, PhD","SUB_INVESTIGATOR",{"name":100,"role":101},"Krista Schendel Parker, PhD BA","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},38.58157,-121.4944,[106,110],{"name":107,"role":89,"phone":108,"email":109},"Krista S Parker, PhD BA","(925) 372-2513","Krista.Parker@va.gov",{"name":93,"role":89,"phone":94,"email":95},[112],{"name":100,"affiliation":81,"role":101},[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117,19],"Brain Injury",[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an observational study involving 100 Veteran stroke survivors. Participants will receive both the Active Driver Training and the Control Intervention, with the order of these trainings randomly assigned.","completed","Driver Simulator Training After Stroke","This study is looking at how driver simulator training can help Veterans who have had a stroke improve their driving skills. You would participate in two types of training: an Active Driver Training, which focuses on specific skills like speed management and avoiding collisions, and a Control Intervention, which helps you get used to the simulator without complex scenarios. Researchers will measure your driving performance after each training and again six months later to see how well the skills last. This study is for U.S. Veterans aged 40-80 who have had a stroke at least three months ago, are right-hand dominant, and have a driver's license. The goal is to understand if the active training helps improve driving scores.","Your driving performance will be re-assessed six months after the interventions to see how stable the improvements are.",119,"You would have weekly training sessions for three consecutive weeks for each intervention, followed by a driving assessment. After a one-week break, you would complete the other intervention for three weeks, followed by another assessment.","Not stated in the trial record.",[41],"v2"]