NCT07538076

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

April 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 12, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

Visuospatial NeglectSpatial NeglectStroke RehabilitationDigital AssessmentWeb-Based AssessmentStar Cancellation TestLine Bisection TestNeuropsychological Testing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline (single assessment during study visit)

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Other Outcomes (1)

  • Participant-Reported Feasibility of the Digital Tests

    Baseline (single assessment immediately after test completion)

Study Arms (3)

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.

Diagnostic Test: Web-Based Star Cancellation TestDiagnostic Test: Web-Based Line Bisection Test

Stroke patients without visuospatial neglect

Diagnostic Test: Web-Based Star Cancellation TestDiagnostic Test: Web-Based Line Bisection Test

Control Group

Age- and sex-matched healthy control individuals without a history of neurological disease

Diagnostic Test: Web-Based Star Cancellation TestDiagnostic Test: Web-Based Line Bisection Test

Interventions

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.

Also known as: Line Bisection Test, Digital Line Bisection Test
Control GroupStroke patients with visuospatial neglectStroke patients without visuospatial neglect

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.

Also known as: Digital Star Cancellation Test, Star Cancellation Test
Control GroupStroke patients with visuospatial neglectStroke patients without visuospatial neglect

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Melisa Zengin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 20, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations