The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery

• Conditions: Stroke
• Interventions: Procedure: Acupuncture

• Registration Number: NCT03946566
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Brief Summary

Electronic health records of stroke convalescent patients will be selected from the third affiliated hospital of Zhejiang Chinese Medical University from January 2012 to December 2019. Relevant clinical data will be extracted according to case data, and model-based decision tree analysis will be conducted to establish and evaluate the clinical prediction Model.

Detailed Description

Cases will be screened according to inclusion and exclusion criteria.Patients' basic information, risk factors, types of stroke, TCM diagnosis, all treatment during hospitalization, neurological impairment evaluation, imaging examination results and other contents will be recorded.Finally, statistical processing will be carried out to establish the prediction model, draw ROC curve and evaluate the model.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14
• Study Start: 2019-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Clinical diagnosis of stroke
• The incidence is between 30 days and 180 days
• Age ≥ 18 years old
• The first onset

Exclusion Criteria

• Subarachnoid hemorrhage
• transient ischemic attack
• other intracranial lesions
• Non-atherosclerotic thrombotic cerebral infarction
• Surgery, trauma, congenital disability leading to limb dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture	Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Basic treatment group	Acupuncture	Use basic treatments, such as western medicine.

Primary Outcome Measures

Name	Time	Method
Clinical Neurological Functional Impairment Assessment for Stroke Patients	Change from neurological functional impairment score at 6 months(or the last discharge time ，which less than 6 months)	To evaluate the consciousness, muscle power, dysarthria, sensory disturbancen and ataxia of stroke patients on the first day, the seventh day, the fifteenth day, the first month and the sixth month after admission (or the last time of discharge).The total score is 0-29 points. The lower the score, the less the neurological defect. The efficacy will be assessed as an improvement in the neurological functional impairment score (eg, score improvement = score at admission - score at discharge), and treatment was effective when the score was reduced by more than 18%.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China