Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIstanbul Medeniyet University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Web-Based Star Cancellation Test

    Diagnostic 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 Test

    Diagnostic 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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Stroke patients with visuospatial neglect2 interventions
Group B: Stroke patients without visuospatial neglect2 interventions
Group C: Control Group2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (single assessment during study visit)
2

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.

Time frame
Baseline (single assessment during study visit)

Secondary outcomes

1

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.

Time frame
Baseline (single assessment during study visit)
2

Completion Time of the Digital Star Cancellation Test

The total time required to complete the digital Star Cancellation Test, recorded automatically by the system.

Time frame
Baseline (single assessment during study visit)
3

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.

Time frame
Baseline (single assessment during study visit)
4

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.

Time frame
Baseline (single assessment during study visit)

Other outcomes

1

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.

Time frame
Baseline (single assessment immediately after test completion)

Sponsors and contacts

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