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

NCT03946566 | Unknown

• 1 other identifier: MRJ-HT-1001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Acupuncture group

Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.

Procedure: Acupuncture

Basic treatment group

Use basic treatments, such as western medicine.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.

Acupuncture group; Basic treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ruijie Ma, Doctor

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

Central Study Contacts

Huiting Yang, Bachelor

CONTACT

+86 15757125322; momoyiyi123456@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

CN (1)