Clinical Validation of an Artificial Intelligence-Based G-FAST Score in Patients With Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Agreement between AI-generated and physician-scored G-FAST scale assessments [Time frame: within 7 days of acute stroke onset]
Secondary outcome measures (3)
- Agreement of AI System vs. Neurologists in Binary G-FAST Classification (Score ≥3 vs. <3) [Time frame: within 7 days of acute stroke onset]
- Bland-Altman Agreement Limit Analysis [Time frame: within 7 days of acute stroke onset]
- Diagnostic performance analysis [Time frame: within 7 days of acute stroke onset]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07538492 · qingfeng ma G-FAST Scale