[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07378592":3,"trial-entities:NCT07378592":120,"trial-summary:NCT07378592":124},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":55,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":73,"locations":76,"central_contacts":91,"overall_officials":98,"references":102,"see_also_links":119},"NCT07378592","IRB-FY2025-237","Driving Simulator Training For Adults With Acquired Brain Injuries","Use Of Driving Simulator To Provide Pre-Driving Training For Adults With Acquired Brain Injuries.","RECRUITING","2026-12-31","2026-01","2026-01-30","2025-11-15","Sacred Heart University","OTHER",false,"The aim of this project is to prepare adults with acquired brain injuries for on-road driving by using the driving simulator and increase participant's comfort level, confidence, and independence within their occupation of driving. The occupational therapy faculty are interested in identifying the impact driving simulation training has on individuals with acquired brain injuries and how it prepares them for on-road driving. We hope that the information from this project will help us gather information on how driving simulation training improves pre-driving skills related to comfort, confidence, and independence.","This is Phase 3 of a project that started as a capstone project in 2021 and continued with Phase 2 in 2022. . In this next phase,participants who qualify for the study will be invited to participate in the study and will be sent a consent form. They will be randomly assigned to either the driving simulator (eightsessions) or eight sessions of traditional occupational therapy as a control group. All participants will have pre- and post-testing using the same assessments. These assessments measure readiness-to-drive. All participants in the control group will be offered drivingsimulator training after completing the traditional occupational therapy sessions. All study participants will be referred to a certified driving rehabilitation specialist for behind-the-wheelassessments after completing of the driving simulation training",[19],"Acquired Brain Injury",[21,22,23,24],"Occupational Therapy","Pre-Driving","Behind-the-Wheel Assessments","Driving Simulation","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},50,"ESTIMATED",[33,38],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Driving Simulation Intervention","The exercises and realistic driving scenarios on the Drive Safety R-300 simulator will enable participants to have an immersive driving experience with interactive traffic, scripted behavior models, and triggered events. The researcher will initially provide more guided feedback during the motor tasks using a series of exercises in the simulator. More difficult motor tasks will be introduced gradually. As clients' motor skills became more refined, driving practice will be introduced in diverse scenarios and environmental conditions to improve the transfer and generalizability of motor skills.",[37],"Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Traditional Occupational Therapy","Traditional occupational therapy interventions are based on typical occupational therapy assessments which assess range of motion, strength, coordination, functional mobility and self care management. Participants will receive sessions that focus on their deficits based on their acquired brain injuries. The researcher will use occupation-based interventions to improve the participants performance in functional tasks and performance in areas of occupations such as self care, leisure, play, health care management, and work.",[42],"Control - Traditonal Occupational Therapy",[44,48,52],{"measure":45,"description":46,"timeFrame":47},"Useful Field of View Assessment","This is a cognitive assessment that reliably predicts crash risk in drivers. There are 3 sub tests: Processing Speed, Divided Attention, and Selective Attention, which are measured in milliseconds (ms). The 3 sub-tests contribute to an Index score which ranges from 1-5 (Very Low Risk to High Risk of vehicular crash)","8-16 weeks",{"measure":49,"description":50,"timeFrame":51},"Motor Free Visual Perceptual Test","This assessment measure is meant to assess visual perception independent of motor ability. The unit of measurement is age equivalent in years and months","After 16 intervention sessions",{"measure":53,"description":54,"timeFrame":47},"Trails A and B assessment","This are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function. The subject is required to connect 25 encircled numbers by pencil line (Part A) and 25 alternating encircled numbers and letters (Part B) in correct order. The unit of measurement is seconds.",[56],{"measure":57,"description":58,"timeFrame":47},"Behind-the-Wheel Assessment","Participants will be referred to a certified driving rehabiliation specialist for a behind-the-wheel assessment after completing their 8 intervention sessions. The unit of measurement is Pass or Fail","ALL","18 Years",null,{"inclusion":63,"exclusion":68,"raw_text":72},[64,65,66,67],"Adult participants over 18 years","Diagnosed acquired brain injury","A valid driver's license","History of driving prior to injury",[69,70,71],"Age less than 18 years","Moderate to severe cognitive impairment, as measured on the Montreal Cognitive Assessment","Visual acuity or visual field issues","Inclusion Criteria:\n\n* Adult participants over 18 years\n* Diagnosed acquired brain injury\n* A valid driver's license\n* History of driving prior to injury\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Moderate to severe cognitive impairment, as measured on the Montreal Cognitive Assessment\n* Visual acuity or visual field issues",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":13,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Fairfield","Connecticut","06825","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Sheelagh","CONTACT","2033654773","schlegels@sacredheart.edu",{"lat":89,"lon":90},41.14121,-73.26373,[92,95],{"name":93,"role":85,"phone":94,"email":87},"Sheelagh M Schlegel, DrHSc, MPH, OTR\u002FL","203 365 4773",{"name":96,"role":85,"email":97},"Stefanie Seanor, EdD., MBA, OTR\u002FL","seanors@sacredheart.edu",[99],{"name":100,"affiliation":13,"role":101},"Sheelagh Schlegel, DrHSc, MPH, OTR\u002FL","PRINCIPAL_INVESTIGATOR",[103,107,110,113,116],{"pmid":104,"type":105,"citation":106},"28559646","BACKGROUND","Blane A, Lee HC, Falkmer T, Willstrand TD. Assessing Cognitive Ability and Simulator-Based Driving Performance in Poststroke Adults. Behav Neurol. 2017;2017:1378308. doi: 10.1155\u002F2017\u002F1378308. Epub 2017 May 7.",{"pmid":108,"type":105,"citation":109},"25397762","Dickerson AE, Meuel DB, Ridenour CD, Cooper K. Assessment tools predicting fitness to drive in older adults: a systematic review. Am J Occup Ther. 2014 Nov-Dec;68(6):670-80. doi: 10.5014\u002Fajot.2014.011833.",{"pmid":111,"type":105,"citation":112},"36672036","Ouellette DS, Kaplan S, Rosario ER. Back on the Road: Comparing Cognitive Assessments to Driving Simulators in Moderate to Severe Traumatic Brain Injuries. Brain Sci. 2022 Dec 28;13(1):54. doi: 10.3390\u002Fbrainsci13010054.",{"pmid":114,"type":105,"citation":115},"23968796","Classen S, Wang Y, Crizzle AM, Winter SM, Lanford DN. Predicting older driver on-road performance by means of the useful field of view and trail making test part B. Am J Occup Ther. 2013 Sep-Oct;67(5):574-82. doi: 10.5014\u002Fajot.2013.008136.",{"pmid":117,"type":105,"citation":118},"31597483","Dimech-Betancourt B, Ross PE, Ponsford JL, Charlton JL, Stolwyk RJ. The development of a simulator-based intervention to rehabilitate driving skills in people with acquired brain injury. Disabil Rehabil Assist Technol. 2021 Apr;16(3):289-300. doi: 10.1080\u002F17483107.2019.1673835. Epub 2019 Oct 9.",[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Brain Injury",[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is an interventional study with 50 planned participants. You would be randomly assigned to one of two groups: driving simulator training or traditional occupational therapy.","completed","Driving Simulator Training for Adults with Acquired Brain Injuries","This study is looking at how driving simulator training can help adults who have had an acquired brain injury (ABI) get ready to drive again. Researchers want to see if using a special driving simulator, called the Drive Safety R-300, helps people feel more comfortable, confident, and independent with driving. You would be randomly assigned to either eight sessions of driving simulator training or eight sessions of traditional occupational therapy. All participants will have tests before and after their sessions to measure their readiness to drive. To join, you need to be over 18, have an acquired brain injury, a valid driver's license, and have driven before your injury. People with moderate to severe thinking problems or certain vision issues cannot participate. The study aims to understand how driving simulation training improves pre-driving skills.","Your readiness-to-drive will be measured at 8-16 weeks and after 16 intervention sessions.",134,"You would participate in eight intervention sessions, either driving simulator training or traditional occupational therapy. You will also have pre- and post-testing using various assessments.","Not stated in the trial record.",[39],"v2"]