Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients

February 6, 2023 updated by: Cathay General Hospital
The investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients:

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acupuncture therapy in traditional Chinese medicine has been verified in many disease by thousands years. Due to the feasible and relatively safe in acupuncture management, now the west countries had been well document about acupuncture in medicine. The acupuncture therapy applied in post stroke functional recovery has been considered as more benefit than physical therapy only to post stroke rehabilitation. However, the effect of combined acupuncture therapy with standard management in acute stroke patient still remains unknown. The aim of this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients. The prospective study was designed as a randomized, single blinded, control trial. We collected newly onset of acute ischemic stroke patient without underling systemic major illness, and randomized assign the collected patients into two groups as experimental (acupuncture)group and normal control group. The two groups both treat with routine western medicine as standard stroke therapy. The outcome measurement will evaluate by the changes from baseline at one and three months. The assessed scales including NIH stroke scale, the Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the Modified Rankin Scale. We compared the all variable measurements to see if any benefit from acupuncture group than the control group.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

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

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • newly onset of acute ischemic stroke,Exclusion Criteria:
  • without underling systemic major illness

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: acupuncture
The acupuncture treatment for the intervention group was provided once daily for 2 weeks.
Other: acupuncture
Intervention with acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
National Institute of Health Stroke Scale
Time Frame: the fourth week
the fourth week
Fugal-Mayer Assessment
Time Frame: The fourth week
The fourth week
Functional Independent Measure
Time Frame: The fourth week
The fourth week

Secondary Outcome Measures

Outcome Measure
Time Frame
National Institute of Health Stroke Scale
Time Frame: The three months after admission
The three months after admission
Barthel index
Time Frame: The three month after admission
The three month after admission
Modified Rankin Scale
Time Frame: The three after admission
The three after admission

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: The two week
Adverse events was monitored in each acupuncture maneuver and post therapeutic course two weeks later.
The two week

Collaborators and Investigators

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

Sponsor

Cathay General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (ESTIMATE)

August 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGHIRBCT-P-100002

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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