Lu's Acupuncture and Moxibustion Treatment on Stroke (LAMTS)

August 10, 2021 updated by: Shanghai University of Traditional Chinese Medicine

Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke

There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Longhua Hospital,Shanghai University of Traditional Chinese Medicine
        • Sub-Investigator:
          • Jun Wang, MD
        • 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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The ages of stroke patients from 40 years old to 70 years old.
  • The principle diagnosis according to <diagnosis-treatment criteria of stroke(trial implementation)>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.
  • Recent stroke from 7 days to 6 months after onset.
  • Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS>8.
  • Written informed consent by inpatient.

Exclusion Criteria:

  • Stroke with conscious disturbance or serious cognitive impairment.
  • Stroke with limb spasm；ASHWORTH≥1.
  • Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.
  • Being oversensitive to electrical stimulus.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
acupuncture
Procedure: Acupuncture
The treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total.
Experimental: Rehabilitation
rehabilitation exercise
Procedure: Rehabilitation
The matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all.
Other Names:
  • Rehabilitation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simplified Fugl-Meyer Scale
Time Frame: 8 weeks
5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of Stroke Scale-Boss
Time Frame: 6 months
5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
6 months
Modified Barthel Index
Time Frame: 6 months
5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
6 months

Collaborators and Investigators

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

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Fudan University

Investigators

  • Study Chair: Yi Wu, MD, Huashan Hospital
  • Study Director: Jie Jia, MD, Huashan Hospital
  • Study Director: Yi Song, MM, Shanghai University of Traditional Chinese Medicine
  • Principal Investigator: Zouqin Huang, MM, Shanghai University of Traditional Chinese Medicine
  • Principal Investigator: Xiaoxin You, MM, Shanghai University of Traditional Chinese Medicine
  • Principal Investigator: Qinhui FU, MD, Shanghai University of Traditional Chinese Medicine
  • Principal Investigator: Jun Wang, MM, Shanghai University of Traditional Chinese Medicine

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

March 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3534123123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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