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

NCT07544927 | Not Yet Recruiting

• 1 other identifier: qingfeng ma AI mRS
• Study Type: observational
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Keywords

Stroke; Modified Rankin Scale; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

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

  The weighted kappa coefficient quantifies the level of agreement between the Artificial Intelligence (AI)-generated Modified Rankin Scale (mRS) scores and the standardized manual mRS assessments performed by trained clinicians

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

Secondary Outcomes (3)

• Agreement Between AI-based and Manual Assessments of Dichotomized Modified Rankin Scale (mRS)

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

• Bland-Altman Limits of Agreement Between AI and Manual Modified Rankin Scale (mRS) Scores

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

• Diagnostic Performance of AI-Based vs. Manual Modified Rankin Scale (mRS) Dichotomization

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

Study Arms (2)

AI-first interview group

Participants first receive telephone assessment by AI, followed by telephone assessment by human assessors.

Human-first group

Participants first receive telephone assessment by human assessors, followed by telephone assessment by AI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive stroke patients from multiple centers who are ≥18 years old, with confirmed stroke, and able to complete the 1-week follow-up will be enrolled. Patients with severe non-stroke neurological diseases, inability to communicate, or loss to follow-up will be excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Capital Medical University: collaborator
• People's Hospital of Beijing Daxing District: collaborator
• Beijing Tiantan Hospital: collaborator
• The First Hospital of Fangshan District,Beijing: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qingfeng Ma, MD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Qingfeng Ma, MD

CONTACT

+8613601069493; m.qingfeng@163.com

Zixin Wang, MD Candidate

CONTACT

+8615031041048; wzx15031041048@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share