Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:48 PM
Study NCT ID:
NCT07378592
Status:
RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Driving Simulator Training For Adults With Acquired Brain Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-01', 'size': 169530, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-06T15:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Useful Field of View Assessment', 'timeFrame': '8-16 weeks', 'description': '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)'}, {'measure': 'Motor Free Visual Perceptual Test', 'timeFrame': 'After 16 intervention sessions', 'description': 'This assessment measure is meant to assess visual perception independent of motor ability. The unit of measurement is age equivalent in years and months'}, {'measure': 'Trails A and B assessment', 'timeFrame': '8-16 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Behind-the-Wheel Assessment', 'timeFrame': '8-16 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Occupational Therapy', 'Pre-Driving', 'Behind-the-Wheel Assessments', 'Driving Simulation'], 'conditions': ['Acquired Brain Injury']}, 'referencesModule': {'references': [{'pmid': '28559646', 'type': 'BACKGROUND', 'citation': '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: 10.1155/2017/1378308. Epub 2017 May 7.'}, {'pmid': '25397762', 'type': 'BACKGROUND', 'citation': '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/ajot.2014.011833.'}, {'pmid': '36672036', 'type': 'BACKGROUND', 'citation': '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/brainsci13010054.'}, {'pmid': '23968796', 'type': 'BACKGROUND', 'citation': '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/ajot.2013.008136.'}, {'pmid': '31597483', 'type': 'BACKGROUND', 'citation': '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: 10.1080/17483107.2019.1673835. Epub 2019 Oct 9.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT07378592', 'briefTitle': 'Driving Simulator Training For Adults With Acquired Brain Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Sacred Heart University'}, 'officialTitle': 'Use Of Driving Simulator To Provide Pre-Driving Training For Adults With Acquired Brain Injuries.', 'orgStudyIdInfo': {'id': 'IRB-FY2025-237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention', 'description': "Participants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group.\n\nClients in the driving simulator intervention arm will receive eight sessions in a Drive Safety R-300 driving simulator. This simulator is a partial Ford Focus cab with a full interior, standard driving controls, and instrumentation, 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.", 'interventionNames': ['Other: Driving Simulation Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Traditonal Occupational Therapy', 'description': 'Participants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group.\n\nParticipants in the control, occupational therapy group will receive interventions 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 using occupation-based interventions to improve their assessed deficits.', 'interventionNames': ['Other: Traditional Occupational Therapy']}], 'interventions': [{'name': 'Driving Simulation Intervention', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention']}, {'name': 'Traditional Occupational Therapy', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control - Traditonal Occupational Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06825', 'city': 'Fairfield', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sheelagh', 'role': 'CONTACT', 'email': 'schlegels@sacredheart.edu', 'phone': '2033654773'}], 'facility': 'Sacred Heart University', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}], 'centralContacts': [{'name': 'Sheelagh M Schlegel, DrHSc, MPH, OTR/L', 'role': 'CONTACT', 'email': 'schlegels@sacredheart.edu', 'phone': '203 365 4773'}, {'name': 'Stefanie Seanor, EdD., MBA, OTR/L', 'role': 'CONTACT', 'email': 'seanors@sacredheart.edu'}], 'overallOfficials': [{'name': 'Sheelagh Schlegel, DrHSc, MPH, OTR/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacred Heart University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '1/1/2027 - 12/31/2029', 'ipdSharing': 'YES', 'description': 'Data on the study protocol for the driving simulation and data showing performance on the neuropsychological assessments', 'accessCriteria': 'Driving Simulation researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sacred Heart University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}