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

Обзор

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.

Подробное описание

This is a prospective, multicenter, observational study designed to validate the diagnostic performance of an AI-based automated scoring system for the Modified Rankin Scale (mRS) in patients with stroke. The primary objective is to evaluate the agreement between AI-generated mRS scores and standardized manual assessments conducted by trained clinicians. Secondary endpoints include the system's sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) in classifying functional outcomes.

Первичные конечные точки

• Agreement Between Artificial Intelligence (AI)-Based and Manual Modified Rankin Scale (mRS) Assessments [Срок оценки: 7 days post-discharge or post-outpatient visit, ± 2 days]

Вторичные конечные точки (3)

• Agreement Between AI-based and Manual Assessments of Dichotomized Modified Rankin Scale (mRS) [Срок оценки: 7 days post-discharge or post-outpatient visit, ± 2 days]
• Bland-Altman Limits of Agreement Between AI and Manual Modified Rankin Scale (mRS) Scores [Срок оценки: 7 days post-discharge or post-outpatient visit, ± 2 days]
• Diagnostic Performance of AI-Based vs. Manual Modified Rankin Scale (mRS) Dichotomization [Срок оценки: 7 days post-discharge or post-outpatient visit, ± 2 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07544927 · qingfeng ma AI mRS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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