[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07463755":3,"trial-entities:NCT07463755":183,"trial-summary:NCT07463755":187},{"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":38,"secondary_outcomes":46,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":109,"locations":112,"central_contacts":141,"overall_officials":146,"references":147,"see_also_links":182},"NCT07463755","STUDY00161777","Low-Fidelity Driving Simulator Training in Parkinson's Disease.","Low-Fidelity Driving Simulator Training and Driving Outcomes in Parkinson's Disease: A Pilot Randomized Control Study","NOT_YET_RECRUITING","2027-04-30","2026-03","2026-03-11","2026-04-15","University of Kansas Medical Center","OTHER",false,"The goal of this clinical trial is to learn if low-fidelity driving simulator training works to improve cognitive performance, driving behavior, and driving aptitude in individuals with Parkinson's disease. The main questions it aims to answer are:\n\n* Does low-fidelity driving simulator training improve cognitive performance?\n* Does low-fidelity driving simulator training improve driving performance?\n* Does low-fidelity driving simulator training improve driving aptitude?\n\nResearchers will compare driving simulator training to no-training (waitlist control group) to see if the low-fidelity driving simulator is effective in individuals with Parkinson's disease.\n\nParticipants will:\n\n* Undergo 10 sessions of driving simulator training or be placed in the no-training group.\n* Training group participants will visit the driving simulator lab 2-3 times a week for 4 weeks for training.\n* Paper-based tests and driving simulator tests will be done before and after 10 sessions of training (or a waiting period).","Driving is an important activity of daily living for most people in the United States, including older adults. It is an integral part of mobility, independent living, and physical, social, and economic well-being. Parkinson's disease is the second most common neurodegenerative disease, and it is an important societal issue and global priority. A recent survey study has reported that 84% of pwPD held a driving license. Among pwPD holding a driving license, 15% reported being involved in a motor vehicle crash in the past 3 years. Another study reported that among pwPD involved in motor vehicle crashes, 11% of them were at-fault collisions, which raises safety concerns among drivers with PD.5 Several studies have established that pwPD exhibit impaired driving skills evaluated on driving simulator experiments and on-road tests. Despite the challenges associated with driving in persons with Parkinson's disease, it is indicated that they can learn specific tasks but require more practice than healthy controls. In this study, we attempt to evaluate the training effectiveness of a portable driving simulator in improving cognitive performance, driver behavior, and aptitude in pwPD.",[19],"Parkinson's Disease (PD)",[21,22,23,24],"Low-fidelity driving simulator","Parkinson's disease","Cognitive performance","Driving performance","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},36,"ESTIMATED",[33],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Low-fidelity driving simulator training","Participants in the treatment group will undergo 10 sessions of training on a low-fidelity driving simulator. Each session will last approximately 45-60 minutes. There will be 2-3 sessions each week for 4 weeks.",[37],"Training",[39,43],{"measure":40,"description":41,"timeFrame":42},"Driving performance - Standard Lane Deviation Position","SDLP refers to the mean Lane position of the driver's vehicle to the roadway centerline (defined as zero). The center of the vehicle is the reference point. Positive values indicate lane positions on the right side of the road; negative values indicate left. Default roadway lane widths are 12 ft (3.66 m) across; therefore, values close to 6 ft (1.83 m) indicate positioning near the center of a lane.","Baseline (pre-intervention) and at 4 weeks (post-intervention)",{"measure":44,"description":45,"timeFrame":42},"Driving aptitude - The Adelaide Driving Self-Efficacy Scale","The Adelaide Driving Self-Efficacy Scale is a self-reported assessment of participants' beliefs in their capability to organize and execute actions towards safe driving. It is a 12-item questionnaire that measures an individual's self-perceived confidence in performing various driving-related activities, such as driving in heavy traffic or at night. It uses a 0 (not confident at all) to 10 (completely confident) rating scale for each activity, with total scores indicating overall driving confidence.",[47,50,53,56,59,62,65,68,71,74,77,80,83,86],{"measure":48,"description":49,"timeFrame":42},"Cognitive performance - Montreal Cognitive Assessment","The Montreal Cognitive Assessment is a brief screening tool used to detect mild cognitive impairment and early dementia. It evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. Total score is 30 points.\n\n\\> or = 26 ---- Normal 18 to 25 ----- Mild cognitive impairment",{"measure":51,"description":52,"timeFrame":42},"Cognitive performance - Dot cancellation test errors","The Dot Cancellation Test is a neuropsychological evaluation tool used to assess focus, attention, visual scanning, and occasionally motor speed or neglect. It is also referred to as the Cancellation Test or Visual Cancellation Task. The participant is given a page with a random cluster of dots and instructed to cross out (cancel) a particular type of cluster of dots. The investigator calculates the time taken and the number of errors committed by the participant.",{"measure":54,"description":55,"timeFrame":42},"Cognitive performance - Rey-Osterrieth Complex Figure Copy","The Rey-Rey-Osterrieth Complex Figure Copy Test is a neuropsychological tool used to assess visuospatial constructional ability, planning, and organizational skills. The individual is asked to copy a complex geometric figure, and their drawing is scored based on the accuracy and placement of 18 specific design components. The score ranges from 0 to 36. A higher score indicates better performance.",{"measure":57,"description":58,"timeFrame":42},"Cognitive performance - Trail Making Tests A & B","The Trail Making Test is a paper-and-pencil assessment used to measure attention, processing speed, and executive function. It has two parts: TMT-A, where individuals connect numbers in sequence (1-25), primarily tests visual scanning and processing speed. TMT-B requires alternating between numbers and letters in order (1-A-2-B, etc.), placing greater demand on cognitive flexibility and set-shifting.",{"measure":60,"description":61,"timeFrame":42},"Cognitive performance - Snellgrove Maze Task","The Snellgrove Maze Task is a paper-and-pencil test designed to screen for cognitive and executive function impairments that may affect safe driving. The participant is asked to navigate a complex maze as quickly and accurately as possible without lifting the pencil from the page. Performance is measured by time to completion and number of errors (e.g., wrong turns, dead ends). Longer times and higher error counts are associated with poorer executive function.",{"measure":63,"description":64,"timeFrame":42},"Cognitive performance - Stroke Driver Screening Assessment (US version)","The Stroke Driver Screening Assessment (SDSA) is a standardized battery of paper-and-pencil tests developed to predict fitness to drive after stroke or other brain injuries. It includes subtests such as Dot Cancellation (visual attention), Directions Test (visuospatial and executive skills), Road Sign Recognition (memory and comprehension), and Compass Test (spatial orientation).",{"measure":66,"description":67,"timeFrame":42},"Driving performance - Divided attention","Divided attention in simulator evaluations refers to a driver's ability to manage driving tasks while simultaneously responding to secondary demands, such as detecting shapes. Performance is typically measured by reaction time, accuracy of responses, and driving stability (lane keeping, speed control) during the dual-task condition. Poor divided attention scores suggest reduced cognitive flexibility and higher crash risk.",{"measure":69,"description":70,"timeFrame":42},"Driving performance - Time to Collision","Time to Collision is a safety metric in driving simulator evaluations that estimates how long it would take for a driver to collide with a lead vehicle or hazard if both maintained their current speed and trajectory. A shorter TTC indicates less available reaction time and a higher crash risk. Critical thresholds (often ≤ 1.5-2.0 seconds) are used to identify unsafe or delayed responses.",{"measure":72,"description":73,"timeFrame":42},"Driving Performance - Navigating Intersections","Navigating intersections in simulator evaluations assesses a driver's ability to manage visual scanning, hazard perception, decision-making, and vehicle control while navigating an intersection. The performance is measured by gap acceptance.",{"measure":75,"description":76,"timeFrame":42},"Driving performance - Complex Brake Reaction Time","Complex Brake Reaction Time in simulator evaluations measures how quickly a driver can detect an unexpected hazard, process the situation, and apply the brake in a more demanding context. Longer Complex Brake Reaction Time indicates delayed hazard response and higher crash risk.",{"measure":78,"description":79,"timeFrame":42},"Driving performance - Driver errors.","Driver mistakes, such as the number of collisions, the number of lane positioning errors, total number of tickets, will be recorded during the simulator drive assessment. Higher scores indicate poor driving performance.",{"measure":81,"description":82,"timeFrame":42},"Driving performance - The Test Ride for Investigating Practical Fitness to Drive driving simulator score","The Test Ride for Investigating Practical Fitness to Drive is a structured driving simulator assessment developed to evaluate the practical fitness to drive of older adults and individuals with medical conditions. Total items are 49 scored on an ordinal scale of 1-4. Total score is 196. A higher score indicates better driving performance.",{"measure":84,"description":85,"timeFrame":42},"Driving aptitude - Driver Comfort Questionnaire","The Driver Comfort Questionnaire is a self-report questionnaire designed to assess how comfortable and confident individuals feel in different driving situations. It is scored between 0 and 100 percent. A higher score indicates a higher comfort level of driving.",{"measure":87,"description":88,"timeFrame":42},"Driving aptitude - Driving and Riding Avoidance Scale","The Driving and Riding Avoidance Scale is a questionnaire that measures the extent to which individuals avoid certain driving or riding situations due to discomfort, anxiety, or reduced confidence. There are 20 items in this questionnaire. Each item is scored 0-4. A lower score indicates less avoidance behavior.","ALL","30 Years",null,{"inclusion":93,"exclusion":101,"raw_text":108},[94,95,96,97,98,99,100],"Individuals with Parkinson's disease diagnosed by a movement disorder specialist.","Diagnosis of PD was based on the UK Brain Bank Diagnostic Criteria.","Hoehn and Yahr stage 1 to 3 in the medication ON state with no troublesome dyskinesia.","Minimum binocular acuity of 20\u002F40 or better at least in one eye according to the Kansas DMV statutes.","Montreal Cognitive Assessment (MoCA) ≥ 20.","Ambulates independently with or without walking aids.","Possess a valid driver's license.",[102,103,104,105,106,107],"Any concomitant neurological comorbidity, such as stroke, traumatic brain injury, or multiple sclerosis, that would hinder driving.","Atypical forms of Parkinsonism","History of substance abuse in the last 10 years.","History of uncontrolled psychiatric problems","Undergone deep brain stimulation or focused ultrasound treatment","Uncontrolled diabetes mellitus","Inclusion Criteria:\n\n* Individuals with Parkinson's disease diagnosed by a movement disorder specialist.\n* Diagnosis of PD was based on the UK Brain Bank Diagnostic Criteria.\n* Hoehn and Yahr stage 1 to 3 in the medication ON state with no troublesome dyskinesia.\n* Minimum binocular acuity of 20\u002F40 or better at least in one eye according to the Kansas DMV statutes.\n* Montreal Cognitive Assessment (MoCA) ≥ 20.\n* Ambulates independently with or without walking aids.\n* Possess a valid driver's license.\n\nExclusion Criteria:\n\n* Any concomitant neurological comorbidity, such as stroke, traumatic brain injury, or multiple sclerosis, that would hinder driving.\n* Atypical forms of Parkinsonism\n* History of substance abuse in the last 10 years.\n* History of uncontrolled psychiatric problems\n* Undergone deep brain stimulation or focused ultrasound treatment\n* Uncontrolled diabetes mellitus",[110,111],"ADULT","OLDER_ADULT",[113],{"facility":114,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":138},"Mobility and Falls Lab","Kansas City","Kansas","66103","United States",[120,125,128,131,132,134,136],{"name":121,"role":122,"phone":123,"email":124},"Samuel K Durairaj, MPT","CONTACT","913-326-7999","sdurairaj@kumc.edu",{"name":126,"role":127},"Abiodun E Akinwuntan, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":129,"role":130},"Hannes Devos, PhD","SUB_INVESTIGATOR",{"name":121,"role":130},{"name":133,"role":130},"Kelly Lyons, PhD",{"name":135,"role":130},"Jianghua He, PhD",{"name":137,"role":130},"Linda D'Silva, PhD",{"lat":139,"lon":140},39.11417,-94.62746,[142],{"name":126,"role":122,"phone":143,"phoneExt":144,"email":145},"913-588-5235","711 TTY","aakinwuntan@kumc.edu",[],[148,152,155,158,161,164,167,170,173,176,179],{"pmid":149,"type":150,"citation":151},"16186521","BACKGROUND","Akinwuntan AE, De Weerdt W, Feys H, Pauwels J, Baten G, Arno P, Kiekens C. Effect of simulator training on driving after stroke: a randomized controlled trial. Neurology. 2005 Sep 27;65(6):843-50. doi: 10.1212\u002F01.wnl.0000171749.71919.fa.",{"pmid":153,"type":150,"citation":154},"20944662","Redgrave P, Rodriguez M, Smith Y, Rodriguez-Oroz MC, Lehericy S, Bergman H, Agid Y, DeLong MR, Obeso JA. Goal-directed and habitual control in the basal ganglia: implications for Parkinson's disease. Nat Rev Neurosci. 2010 Nov;11(11):760-72. doi: 10.1038\u002Fnrn2915. Epub 2010 Oct 14.",{"pmid":156,"type":150,"citation":157},"17909156","Devos H, Vandenberghe W, Nieuwboer A, Tant M, Baten G, De Weerdt W. Predictors of fitness to drive in people with Parkinson disease. Neurology. 2007 Oct 2;69(14):1434-41. doi: 10.1212\u002F01.wnl.0000277640.58685.fc.",{"pmid":159,"type":150,"citation":160},"15654027","Wood JM, Worringham C, Kerr G, Mallon K, Silburn P. Quantitative assessment of driving performance in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):176-80. doi: 10.1136\u002Fjnnp.2004.047118.",{"pmid":162,"type":150,"citation":163},"19805726","Uc EY, Rizzo M, Anderson SW, Dastrup E, Sparks JD, Dawson JD. Driving under low-contrast visibility conditions in Parkinson disease. Neurology. 2009 Oct 6;73(14):1103-10. doi: 10.1212\u002FWNL.0b013e3181bacf6e.",{"pmid":165,"type":150,"citation":166},"15747369","Stolwyk RJ, Triggs TJ, Charlton JL, Iansek R, Bradshaw JL. Impact of internal versus external cueing on driving performance in people with Parkinson's disease. Mov Disord. 2005 Jul;20(7):846-57. doi: 10.1002\u002Fmds.20420.",{"pmid":168,"type":150,"citation":169},"15726539","Meindorfner C, Korner Y, Moller JC, Stiasny-Kolster K, Oertel WH, Kruger HP. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005 Jul;20(7):832-42. doi: 10.1002\u002Fmds.20412.",{"pmid":171,"type":150,"citation":172},"34542030","Brock P, Oates LL, Gray WK, Henderson EJ, Mann H, Haunton VJ, Skelly R, Hand A, Davies ML, Walker RW. Driving and Parkinson's Disease: A Survey of the Patient's Perspective. J Parkinsons Dis. 2022;12(1):465-471. doi: 10.3233\u002FJPD-212686.",{"pmid":174,"type":150,"citation":175},"24976103","Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002\u002Fmds.25945. Epub 2014 Jun 28.",{"pmid":177,"type":150,"citation":178},"17082464","Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. doi: 10.1212\u002F01.wnl.0000247740.47667.03. Epub 2006 Nov 2.",{"pmid":180,"type":150,"citation":181},"14636668","Collia DV, Sharp J, Giesbrecht L. The 2001 National Household Travel Survey: a look into the travel patterns of older Americans. J Safety Res. 2003;34(4):461-70. doi: 10.1016\u002Fj.jsr.2003.10.001.",[],{"nct_id":4,"conditions":184,"biomarkers":186},[185],"Parkinson Disease",[],{"nct_id":4,"found":188,"summary":189,"prompt_version":199},true,{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This interventional study plans to enroll 36 participants. It compares a group receiving driving simulator training to a group that does not.","completed","Low-Fidelity Driving Simulator Training for Parkinson's Disease","This study is looking at whether training on a low-fidelity driving simulator can help people with Parkinson's disease improve their driving skills and thinking abilities. Researchers want to see if this training can improve how well you drive and your confidence in driving. You could join if you have Parkinson's disease (Hoehn and Yahr stage 1 to 3), are between 30 years old and none specified, and have good vision. Participants will either receive 10 sessions of driving simulator training or be in a group that doesn't receive training right away. The main goals are to measure your driving performance and how confident you feel about driving before and after the training period. The current status of this study is unclear.","Driving performance and aptitude will be measured at baseline (before training) and at 4 weeks (after training).",121,"If you are in the training group, you would have 10 sessions on a driving simulator, each lasting 45-60 minutes, 2-3 times a week for 4 weeks.","Not stated in the trial record.",[],"v2"]