Not Yet RecruitingNot Applicable

Clinical Validation of an Artificial Intelligence-Based Scoring System for the Modified Rankin Scale (mRS) in Patients With Stroke

490 participantsStarted 2026-04-10

Plain-language summary

This study aims to validate the clinical performance of an artificial intelligence (AI)-based automatic scoring system for the Modified Rankin Scale (mRS). The core comparison is the consistency and accuracy between the AI-generated scores and standardized manual mRS follow-up assessments performed by trained professionals. The goal is to provide a convenient, efficient, and objective tool for stroke prognosis assessment, reduce the subjective variability of manual scoring, and optimize the stroke follow-up workflow.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years, male or female.
✓. Clinically diagnosed with stroke, and confirmed by cranial CT/MRI to have stroke.
✓. Clinically stable, with basic communication ability at discharge or outpatient visit. The patient or a fixed family caregiver is able to cooperate with telephone follow-up at 1 week after discharge or outpatient visit.
✓. Signed informed consent by the patient or their legally authorized representative.

Exclusion criteria

✕. Neurological deficits caused by non-stroke etiologies (e.g., brain tumor, traumatic brain injury, encephalitis).
✕. Presence of severe disturbance of consciousness, severe cognitive impairment, psychiatric disorders, or global aphasia at discharge/outpatient visit, preventing effective communication; neither the patient nor family can cooperate with follow-up or assessment.
✕. Combined with severe multi-organ failure (e.g., cardiac, hepatic, renal, respiratory), with an expected survival of less than 1 month, making completion of the 1-week follow-up impossible.
✕. Long-term bedridden without a fixed caregiver, with no confirmed contact for follow-up, or refusal to participate in telephone follow-up and mRS assessment.
✕. Incomplete clinical data, preventing baseline data collection.

What they're measuring

Agreement Between Artificial Intelligence (AI)-Based and Manual Modified Rankin Scale (mRS) Assessments

Timeframe: 7 days post-discharge or post-outpatient visit, ± 2 days

Trial details

NCT IDNCT07544927

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Qingfeng Ma, MD

+8613601069493 m.qingfeng@163.com

View on ClinicalTrials.gov More Stroke trials