StrokeNCT07538076
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
An observational study of Stroke and Spatial Neglect, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spatial Neglect, Spatial Neglect After Stroke
- What is being tested?
- Web-Based Star Cancellation Test and Web-Based Line Bisection Test
- Type of treatment
- Pill or oral medicine
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, Kadikoy, 34722
Melisa Zengin, MD, +905414005688, melisazngn@gmail.com
About this study
Official title: Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients
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:
Read more
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
Read the detailed description
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.
- Conditions
- Stroke, Spatial Neglect, Spatial Neglect After Stroke
- Being tested
- Web-Based Star Cancellation Test, Web-Based Line Bisection Test
- Keywords
- Visuospatial Neglect, Spatial Neglect, Stroke Rehabilitation, Digital Assessment, Web-Based Assessment, Star Cancellation Test, Line Bisection Test, Neuropsychological Testing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Star Cancellation TestDiagnostic test
Also called Digital Star Cancellation Test, 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 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.
Web-Based Line Bisection TestDiagnostic test
Also called Line Bisection Test, Digital 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 lines. In the digital version, line positions vary across trials, and deviation from the true midpoint is calculated automatically, along with measures of variability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Web-Based Star Cancellation Test; Diagnostic Test: Web-Based Line Bisection Test | |
| Stroke patients without visuospatial neglect | Not described Receives: Diagnostic Test: Web-Based Star Cancellation Test; Diagnostic Test: Web-Based Line Bisection Test | |
| Control Group | Age- and sex-matched healthy control individuals without a history of neurological disease Receives: Diagnostic Test: Web-Based Star Cancellation Test; Diagnostic Test: Web-Based Line Bisection Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single assessment during study visit)
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.
Measured: Baseline (single assessment during study visit)
Secondary outcomes (7)
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.
Measured: Baseline (single assessment during study visit)
Completion Time of the Digital Star Cancellation Test
The total time required to complete the digital Star Cancellation Test, recorded automatically by the system.
Measured: Baseline (single assessment during study visit)
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.
Measured: Baseline (single assessment during study visit)
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.
Measured: Baseline (single assessment during study visit)
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.
Measured: Baseline (single assessment during study visit)
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.
Measured: Baseline (single assessment during study visit)
Search Path Characteristics in the Digital Star Cancellation Test
Process-based measures describing the pattern of visual search during the digital Star Cancellation Test.
Measured: Baseline (single assessment during study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa Zengin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538076
- Sponsor's protocol ID
- Neglect Tests
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations, and because the data were collected for a single-center academic study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validity of Web Based Star Cancellation Test and Line Bisection Test in the Assessment of Visuospatial Neglect in Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT07538076
- Acronym / sponsor ID
- Neglect Tests
- Conditions
- Stroke, Spatial Neglect, Spatial Neglect After Stroke
- Keywords
- Visuospatial Neglect, Spatial Neglect, Stroke Rehabilitation, Digital Assessment, Web-Based Assessment, Star Cancellation Test, Line Bisection Test, Neuropsychological Testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stroke patients with visuospatial neglect | – | Diagnostic Test: Web-Based Star Cancellation Test, Diagnostic Test: Web-Based Line Bisection TestThe 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. |
| Stroke patients without visuospatial neglect | – | Diagnostic Test: Web-Based Star Cancellation Test, Diagnostic Test: Web-Based Line Bisection Test |
| Control Group | – | Diagnostic Test: Web-Based Star Cancellation Test, Diagnostic Test: Web-Based Line Bisection TestAge- and sex-matched healthy control individuals without a history of neurological disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Star Cancellation TestAlso: Digital Star Cancellation Test, Star Cancellation TestThe 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. | Diagnostic test | Control Group, Stroke patients with visuospatial neglect, Stroke patients without visuospatial neglect |
| Web-Based Line Bisection TestAlso: Line Bisection Test, Digital Line Bisection TestThe 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. | Diagnostic test | Control Group, Stroke patients with visuospatial neglect, Stroke patients without visuospatial neglect |
Primary outcome
Laterality Index of the Digital Star Cancellation 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.
Mean Deviation in the Digital Line Bisection Test
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.
7 secondary outcomes
Omitted Targets in the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Completion Time of the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Search Speed in the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Ineffective or Off-Target Responses in the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Variability of Performance in the Digital Line Bisection Test
Time frame: Baseline (single assessment during study visit)
Time Spent on Each Side of the Screen in the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Search Path Characteristics in the Digital Star Cancellation Test
Time frame: Baseline (single assessment during study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations, and because the data were collected for a single-center academic study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Spatial Neglect, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melisa Zengin, MD (+905414005688, melisazngn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laterality Index of the Digital Star Cancellation Test (time frame: Baseline (single assessment during study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.