Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, Kadikoy, 34722, Turkey (Türkiye)
NCT Number: NCT07538076
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.
The main questions it aims to answer are:
Can 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.
Participants will:
Complete 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
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Istanbul, Kadikoy, 34722, Turkey (Türkiye)
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.
Visuospatial 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.
The 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.
Participants 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.
All 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.
The 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.
Statistical 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.
Data 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.
This 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The 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.
Other names: Digital Star Cancellation Test, Star Cancellation 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.
The 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.
Other names: Line Bisection Test, Digital Line Bisection Test
Time frame: Baseline (single assessment during study visit)
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.
Time frame: Baseline (single assessment during study visit)
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.
Time frame: Baseline (single assessment during study visit)
The total number of target stars not identified during the digital Star Cancellation Test. This measure reflects incomplete visual exploration.
Time frame: Baseline (single assessment during study visit)
The total time required to complete the digital Star Cancellation Test, recorded automatically by the system.
Time frame: Baseline (single assessment during study visit)
The rate of target identification during the digital Star Cancellation Test, used to characterize visual search efficiency.
Time frame: Baseline (single assessment during study visit)
The number of ineffective or off-target marking attempts recorded during the digital Star Cancellation Test.
Time frame: Baseline (single assessment during study visit)
The standard deviation of deviations from the true midpoint across lines in the digital Line Bisection Test, used to assess response variability.
Time frame: Baseline (single assessment during study visit)
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.
Time frame: Baseline (single assessment during study visit)
Process-based measures describing the pattern of visual search during the digital Star Cancellation Test.
Time frame: Baseline (single assessment immediately after test completion)
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.
Contact information is provided by the study sponsor or research team.
Istanbul Medeniyet University
Other
Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients
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