Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Web-Based Star Cancellation Test, Web-Based Line Bisection Test.
- Кому может быть актуально
- Состояния в реестре: Stroke, Spatial Neglect, Spatial Neglect After Stroke. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients
Обзор
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
Подробное описание
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.
Вмешательства
- Диагностический тест 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. The digital Star Cancellation Test is based on the conventional paper-and-pencil version and includes both target and distractor stim - Диагностический тест 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. The digital Line Bisection Test follows the conventional paradigm in which participants are asked to mark the midpoint of horizontal lin
Первичные конечные точки
- Laterality Index of the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Mean Deviation in the Digital Line Bisection Test [Срок оценки: Baseline (single assessment during study visit)]
Вторичные конечные точки (7)
- Omitted Targets in the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Completion Time of the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Search Speed in the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Ineffective or Off-Target Responses in the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Variability of Performance in the Digital Line Bisection Test [Срок оценки: Baseline (single assessment during study visit)]
- Time Spent on Each Side of the Screen in the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
- Search Path Characteristics in the Digital Star Cancellation Test [Срок оценки: Baseline (single assessment during study visit)]
Критерии участия
Критерии включения
- Age 18 to 80 years
- First-ever ischemic or hemorrhagic stroke
- Hemiplegia secondary to stroke
- Stroke in the subacute or chronic phase, defined as 1 to 24 months after stroke onset
- Ability to provide written informed consent
Критерии исключения
- 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
- Severe visual field defect not attributable to visuospatial neglect, such as isolated homonymous hemianopia
- Severe upper extremity motor impairment or apraxia preventing interaction with the tablet or stylus pen
- Inability to understand test instructions, cooperate with the assessment, or complete the evaluation process
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Turkey (Türkiye) · 1 центр
- Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital — Istanbul
Идентификаторы
NCT: NCT07538076 · Neglect Tests