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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03946566

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted May 14, 2019

Study Description

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.

  • Condition or Disease:Stroke
  • Intervention/Treatment: Procedure: Acupuncture
  • Phase: N/A
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 Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 1500 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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%.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
Criteria

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

Contacts and Locations
Contacts

Contact: Huiting Yang, Bachelor +86 15757125322 momoyiyi123456@163.com

Locations

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

Sponsors and Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

Investigators

Study Director: Ruijie Ma, Doctor The Third Affiliated hospital of Zhejiang Chinese Medical University

More Information
  • Responsible Party: The Third Affiliated hospital of Zhejiang Chinese Medical University
  • ClinicalTrials.gov Identifier: NCT03946566 History of Changes
  • Other Study ID Numbers: MRJ-HT-1001
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 14, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Stroke