[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634314":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":63,"overallOfficials":44,"centralContacts":79,"locations":85,"responsibleParty":100,"collaborators":44,"id":104,"slug":44,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":44,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":44,"studyType":117,"phases":44,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":129,"whyStopped":44,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Istanbul Medeniyet University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Laterality Index of the Digital Star Cancellation Test","The laterality index is calculated as the proportion of targets identified on the left side relative to the total number of identified targets. It is used to assess spatial bias and distinguish between participants with and without visuospatial neglect.","Baseline (single assessment during study visit)",{"measure":14,"description":15,"timeFrame":12},"Mean Deviation in the Digital Line Bisection Test","Mean deviation represents the average distance between the participant's marked midpoint and the true midpoint of horizontal lines. It is used as a quantitative measure of spatial bias.",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Omitted Targets in the Digital Star Cancellation Test","The total number of target stars not identified during the digital Star Cancellation Test. This measure reflects incomplete visual exploration.",{"measure":21,"description":22,"timeFrame":12},"Completion Time of the Digital Star Cancellation Test","The total time required to complete the digital Star Cancellation Test, recorded automatically by the system.",{"measure":24,"description":25,"timeFrame":12},"Search Speed in the Digital Star Cancellation Test","The rate of target identification during the digital Star Cancellation Test, used to characterize visual search efficiency.",{"measure":27,"description":28,"timeFrame":12},"Ineffective or Off-Target Responses in the Digital Star Cancellation Test","The number of ineffective or off-target marking attempts recorded during the digital Star Cancellation Test.",{"measure":30,"description":31,"timeFrame":12},"Variability of Performance in the Digital Line Bisection Test","The standard deviation of deviations from the true midpoint across lines in the digital Line Bisection Test, used to assess response variability.",{"measure":33,"description":34,"timeFrame":12},"Time Spent on Each Side of the Screen in the Digital Star Cancellation Test","The amount of time spent exploring the left and right halves of the screen during the digital Star Cancellation Test, recorded automatically by the system. This measure is used to assess lateralized visual exploration patterns.",{"measure":36,"description":37,"timeFrame":12},"Search Path Characteristics in the Digital Star Cancellation Test","Process-based measures describing the pattern of visual search during the digital Star Cancellation Test.",[39],{"measure":40,"description":41,"timeFrame":42},"Participant-Reported Feasibility of the Digital Tests","Feasibility and user experience of the web-based Star Cancellation and Line Bisection tests, assessed using a brief investigator-developed questionnaire administered after completion of the digital assessments.","Baseline (single assessment immediately after test completion)",{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":45,"timePerspective":46,"maskingInfo":44},null,"CASE_CONTROL","CROSS_SECTIONAL","This study is designed as a cross-sectional, comparative, diagnostic accuracy and methodological validation study to evaluate newly developed web-based (browser-based) Star Cancellation Test (SCT) and Line Bisection Test (LBT) for the assessment of visuospatial neglect in hemiplegic stroke patients.\n\nVisuospatial neglect is a common neuropsychological condition following stroke, particularly after right hemisphere lesions, and is associated with significant functional impairment. In clinical practice, neglect is typically assessed using paper-and-pencil tests such as cancellation tasks and line bisection tests. While these methods are widely used, they rely on manual scoring and provide limited information about the underlying search process and performance dynamics.\n\nThe digital tests developed in this study are designed to preserve the core structure and spatial characteristics of conventional assessments while enabling automated scoring and recording of additional performance metrics. These include process-based parameters such as completion time, search speed, search path characteristics, and ineffective or off-target responses. The system operates on a web-based platform without requiring software installation and is accessible through standard consumer devices, aiming to improve standardization, accessibility, and scalability in clinical settings.\n\nParticipants will be recruited from patients admitted to a physical medicine and rehabilitation clinic and will be classified into three groups based on independent clinical assessment: (1) stroke patients with visuospatial neglect, (2) stroke patients without visuospatial neglect, and (3) age- and sex-matched healthy controls without neurological disease. The presence of visuospatial neglect will be determined using routine clinical reference standards, including established paper-and-pencil neuropsychological tests and behavioral assessment scales. Digital test results will not be used in diagnostic classification to avoid incorporation bias.\n\nAll participants will complete both conventional paper-and-pencil and web-based versions of the Star Cancellation Test and Line Bisection Test under standardized conditions in a quiet clinical environment. To minimize potential order effects such as fatigue or learning, the sequence of test administration will be counterbalanced across participants. Digital assessments will be performed using a tablet device and stylus pen to ensure consistency in motor and spatial interaction.\n\nThe primary objective of the study is to evaluate the diagnostic performance of the digital tests in distinguishing between patients with and without visuospatial neglect. Secondary objectives include examining the additional clinical value of process-based digital metrics and assessing the agreement between conventional and digital test outcomes.\n\nStatistical analyses will be conducted to assess diagnostic accuracy using receiver operating characteristic (ROC) curve analysis, including estimation of area under the curve (AUC), sensitivity, and specificity. Multivariate modeling approaches may be applied to explore the contribution of multiple digital parameters to diagnostic classification. Descriptive and correlational analyses will be used to evaluate relationships between digital performance measures and clinical variables.\n\nData will be collected and stored in a secure and anonymized format. Automated data capture within the digital platform will reduce manual entry errors and improve data completeness. All analyses will be performed using standard statistical software.\n\nThis study aims to provide a clinically applicable, accessible, and standardized digital alternative to conventional visuospatial neglect assessment methods, while also contributing novel process-based performance measures to the field.","The study population consists of adult patients with hemiplegic stroke who are admitted to our physical medicine and rehabilitation clinic, as well as age- and sex-matched healthy control individuals without a history of neurological disease.",[50,56,59],{"label":51,"type":44,"description":52,"interventionNames":53},"Stroke patients with visuospatial neglect","The diagnosis of visuospatial neglect will be established using standard paper-and-pencil neuropsychological assessments routinely applied in clinical practice, including the Star Cancellation Test, Line Cancellation Test, Line Bisection Test, Letter Cancellation Test, figure copying tasks, and clock drawing test, along with the Catherine Bergego Scale.\n\nTo classify a participant as having visuospatial neglect, pathological findings must be present in at least two of these assessments, with at least one being a performance-based paper-and-pencil test. These assessments are part of routine clinical evaluation in stroke patients.Digital test results will not be used for diagnostic classification.",[54,55],"Diagnostic Test: Web-Based Star Cancellation Test","Diagnostic Test: Web-Based Line Bisection Test",{"label":57,"type":44,"description":44,"interventionNames":58},"Stroke patients without visuospatial neglect",[54,55],{"label":60,"type":44,"description":61,"interventionNames":62},"Control Group","Age- and sex-matched healthy control individuals without a history of neurological disease",[54,55],[64,72],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DIAGNOSTIC_TEST","Web-Based Star Cancellation Test","The intervention consists of a web-based Star Cancellation Test developed by the study investigators for the assessment of visuospatial neglect. This test is implemented as a browser-based application that can be accessed on standard devices without requiring software installation and is administered using a tablet and stylus pen to ensure consistent interaction.\n\nThe digital Star Cancellation Test is based on the conventional paper-and-pencil version and includes both target and distractor stimuli. In addition to standard scoring, it automatically records performance measures such as the number of omitted targets, laterality index, completion time, search speed, and search path characteristics.",[60,51,57],[70,71],"Digital Star Cancellation Test","Star Cancellation Test",{"type":65,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Web-Based Line Bisection Test","The intervention consists of a web-based Line Bisection Test developed by the study investigators for the assessment of visuospatial neglect. This test is implemented as a browser-based application that can be accessed on standard devices without requiring software installation and is administered using a tablet and stylus pen to ensure consistent interaction.\n\nThe digital Line Bisection Test follows the conventional paradigm in which participants are asked to mark the midpoint of horizontal lines. In the digital version, line positions vary across trials, and deviation from the true midpoint is calculated automatically, along with measures of variability.",[60,51,57],[77,78],"Line Bisection Test","Digital Line Bisection Test",[80],{"name":81,"role":82,"phone":83,"phoneExt":44,"email":84},"Melisa Zengin, MD","CONTACT","+905414005688","melisazngn@gmail.com",[86],{"facility":87,"status":44,"city":88,"state":89,"zip":90,"country":91,"countryCode":44,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital","Istanbul","Kadikoy","34722","Turkey (Türkiye)",{"type":93,"coordinates":94},"Point",[95,96],28.94966,41.01384,{"lat":96,"lon":95},[99],{"name":81,"role":82,"phone":83,"phoneExt":44,"email":84},{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Melisa Zengin","MD","100634314",false,"NCT07538076","Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke","Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients","Inclusion Criteria:\n\n* Age 18 to 80 years\n* First-ever ischemic or hemorrhagic stroke\n* Hemiplegia secondary to stroke\n* Stroke in the subacute or chronic phase, defined as 1 to 24 months after stroke onset\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of neurological or severe psychiatric disease before stroke that could significantly affect cognitive function or attention, such as brain tumor, traumatic brain injury, vasculitis, multiple sclerosis, or schizophrenia\n* Severe visual field defect not attributable to visuospatial neglect, such as isolated homonymous hemianopia\n* Severe upper extremity motor impairment or apraxia preventing interaction with the tablet or stylus pen\n* Inability to understand test instructions, cooperate with the assessment, or complete the evaluation process",true,"ALL","18 Years","80 Years",{"count":115,"type":116},105,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the clinical usability and diagnostic performance of newly developed web-based Star Cancellation and Line Bisection tests in assessing visuospatial neglect in hemiplegic stroke patients. It will also compare these digital tests with conventional paper-and-pencil assessments.\n\nThe main questions it aims to answer are:\n\nCan the web-based Star Cancellation and Line Bisection tests accurately distinguish between stroke patients with and without visuospatial neglect? Do digital test parameters (such as completion time, search speed, and search patterns) provide additional clinical information beyond conventional test scores? Researchers will compare the results of the web-based tests with standard paper-and-pencil tests to evaluate their diagnostic accuracy and clinical validity.\n\nParticipants will:\n\nComplete conventional paper-and-pencil Star Cancellation and Line Bisection tests Perform web-based (digital) versions of the same tests using a tablet and stylus Undergo routine clinical and cognitive assessments as part of standard care Provide demographic and clinical information",[120,121,122],"Stroke","Spatial Neglect","Spatial Neglect After Stroke",[124,121,125,126,127,71,77,128],"Visuospatial Neglect","Stroke Rehabilitation","Digital Assessment","Web-Based Assessment","Neuropsychological Testing","NOT_YET_RECRUITING","2026-04-12",{"date":132,"type":133},"2026-04-20","ACTUAL",{"date":135,"type":116},"2026-04-15",{"date":137,"type":116},"2026-12-01",{"name":5,"class":6},1]