Clinical Validation of an Artificial Intelligence-Based G-FAST Score in Patients With Stroke

April 15, 2026 updated by: qingfeng ma, Xuanwu Hospital, Beijing

This study aims to validate the clinical performance of an artificial intelligence (AI)-based automatic assessment system for the G-FAST score. The core comparison is the consistency and accuracy between AI-generated G-FAST results and standardized manual G-FAST assessments performed by trained professionals. The goal is to provide a convenient, efficient, and objective tool for acute stroke screening and early identification, reduce the subjective variability of manual scoring, and optimize the pre-hospital and in-hospital stroke assessment workflow.

Study Overview

Status

Not yet recruiting

Conditions

Stroke

Study Type

Observational

Enrollment (Estimated)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Qingfeng Ma, MD
Phone Number: +8613601069493
Email: m.qingfeng@163.com

Study Contact Backup

Name: Zixin Wang, MD Candidate
Phone Number: +8615031041048
Email: wzx15031041048@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke who undergo G-FAST scale assessments using both AI and manual methods.

Description

Inclusion Criteria:

Aged ≥ 18 years, of either sex.
Clinically diagnosed with stroke, and confirmed by cranial CT/MRI to have ischemic or hemorrhagic stroke.
Onset within 7 days.
Alert and oriented, able to cooperate with standardized video and audio data collection.
The patient or their legally authorized representative understands the study and voluntarily provides written informed consent (including consent for audio-visual data collection).

Exclusion Criteria:

Neurological deficits caused by non-stroke etiologies (e.g., brain tumor, traumatic brain injury, encephalitis).
Patients with impaired consciousness, severe cognitive dysfunction, or psychiatric disorders that prevent cooperation with video collection and scale assessment.
Patients with severe visual or hearing impairment, or global aphasia, who are unable to follow instructions.
Critically ill patients requiring immediate cardiopulmonary resuscitation or endotracheal intubation, making video and audio data collection impossible.
Patients with severe facial or limb deformities, or large-area dressings that severely interfere with camera data collection.
Patients with unilateral or bilateral upper limb amputation, severe deformity, unhealed fracture, joint fixation, or severe contracture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
AI-first interview group Participants first undergo G-FAST assessment by AI, followed by G-FAST assessment by human assessors.
Human-first group Participants first undergo G-FAST assessment by human assessors, followed by G-FAST assessment by AI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between AI-generated and physician-scored G-FAST scale assessments Time Frame: within 7 days of acute stroke onset	The agreement between the scores generated by the artificial intelligence (AI) system and the scores assigned by neurologists on G-FAST scale will be evaluated using weighted Kappa coefficients.	within 7 days of acute stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of AI System vs. Neurologists in Binary G-FAST Classification (Score ≥3 vs. <3) Time Frame: within 7 days of acute stroke onset	Kappa coefficient will be calculated to evaluate the agreement between the artificial intelligence (AI) system and neurologist experts in the binary classification of G-FAST scale scores, defined as high risk (total score ≥3) vs. low risk (total score <3) for large vessel occlusion stroke.	within 7 days of acute stroke onset
Bland-Altman Agreement Limit Analysis Time Frame: within 7 days of acute stroke onset	A Bland-Altman plot will be constructed, with the difference between manual scores and AI scores on the vertical axis and the mean of the two scores on the horizontal axis. The limits of agreement (mean difference ± 1.96 × standard deviation) will be calculated.	within 7 days of acute stroke onset
Diagnostic performance analysis Time Frame: within 7 days of acute stroke onset	Taking the manual score as the gold standard, a 2×2 contingency table was constructed to calculate the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and Youden index of the AI scoring system for stratifying the G-FAST score (LVO ≥3 vs. non-LVO <3). The ROC curve was plotted and the AUC was calculated.	within 7 days of acute stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Beijing Tiantan Hospital

Capital Medical University

The First Hospital of Fangshan District,Beijing

People's Hospital of Beijing Daxing District

Investigators

Study Chair: Qingfeng Ma, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)