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Not yet recruiting NCT07538492

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

Conditions: Stroke

Sponsor: Xuanwu Hospital, Beijing

trial.available_in: БГ
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.
Who can participate
Inclusion Criteria: 1. Aged ≥ 18 years, of either sex. 2. Clinically diagnosed with stroke, and confirmed by cranial CT/MRI to have ischemic or hemorrhagic stroke. 3. Onset within 7 days. 4. Alert and oriented, able to cooperate with standardized video and audio data collection. 5. 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: 1. Neurological deficits caused by non-stroke etiologies (e.g., brain tumor, traumatic brain injury, encephalitis). 2. Patients with impaired consciousness, severe cognitive dysfunction, or psychiatric disorders that prevent cooperation with video collection and scale assessment. 3. Patients with severe visual or hearing impairment, or global aphasia, who are unable to follow instructions. 4. Critically ill patients requiring immediate cardiopulmonary resuscitation or endotracheal intubation, making video and audio data collection impossible. 5. Patients with severe facial or limb deformities, or large-area dressings that severely interfere with camera data collection. 6. Patients with unilateral or bilateral upper limb amputation, severe deformity, unhealed fracture, joint fixation, or severe contracture.
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.04.2026
Completion date
31.12.2028
Registry ID
NCT07538492
Source
clinicaltrials.gov
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