Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Laterality Index of the Digital Star Cancellation Test
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
To 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.
干预措施: Web-Based Star Cancellation Test (Diagnostic Test)
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.
To 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.
干预措施: Web-Based Line Bisection Test (Diagnostic Test)
Stroke patients without visuospatial neglect
干预措施: Web-Based Star Cancellation Test (Diagnostic Test)
Stroke patients without visuospatial neglect
干预措施: Web-Based Line Bisection Test (Diagnostic Test)
Control Group
Age- and sex-matched healthy control individuals without a history of neurological disease
干预措施: Web-Based Star Cancellation Test (Diagnostic Test)
Control Group
Age- and sex-matched healthy control individuals without a history of neurological disease
干预措施: Web-Based Line Bisection Test (Diagnostic Test)
结局指标
主要结局
Laterality Index of the Digital Star Cancellation Test
时间窗: 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.
Mean Deviation in the Digital Line Bisection Test
时间窗: 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.
次要结局
- Omitted Targets in the Digital Star Cancellation Test(Baseline (single assessment during study visit))
- Completion Time of the Digital Star Cancellation Test(Baseline (single assessment during study visit))
- Search Speed in the Digital Star Cancellation Test(Baseline (single assessment during study visit))
- Ineffective or Off-Target Responses in the Digital Star Cancellation Test(Baseline (single assessment during study visit))
- Variability of Performance in the Digital Line Bisection Test(Baseline (single assessment during study visit))
- Time Spent on Each Side of the Screen in the Digital Star Cancellation Test(Baseline (single assessment during study visit))
- Search Path Characteristics in the Digital Star Cancellation Test(Baseline (single assessment during study visit))
研究者
Melisa Zengin
MD
Istanbul Medeniyet University