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

May 13, 2019 updated by: Yang Huiting, The Third Affiliated hospital of Zhejiang Chinese Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be stroke convalescent patients from The Third Affiliated Hospital of Zhejiang Chinese Medical University from January 2012 to December 2019.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acupuncture group
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Procedure: Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Basic treatment group
Use basic treatments, such as western medicine.
Procedure: Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRJ-HT-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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