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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03946566
• Other study ID #: MRJ-HT-1001
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2019
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Huiting Yang, Bachelor
• Phone: +86 15757125322
• Email: momoyiyi123456[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Neurological Functional Impairment Assessment for Stroke Patients	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%.	Change from neurological functional impairment score at 6 months(or the last discharge time ,which less than 6 months)