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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01806233
First received: February 26, 2013
Last updated: January 29, 2017
Last verified: January 2017
  Purpose
There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.

Condition Intervention
Ischemic Stroke
Paralysis
Procedure: Acupuncture
Procedure: Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Simplified Fugl-Meyer Scale [ Time Frame: 8 weeks ]
    5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks


Secondary Outcome Measures:
  • Burden of Stroke Scale-Boss [ Time Frame: 6 months ]
    5 times a week, last 4 weeks,assessment on 8 weeks and 6 months

  • Modified Barthel Index [ Time Frame: 6 months ]
    5 times a week, last 4 weeks,assessment on 8 weeks and 6 months


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Rehabilitation 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.
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806233

Contacts
Contact: Jian Pei, MD 021-64385700 ext 3534 jianpei99@yahoo.com

Locations
China
Longhua Hospital,Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, China, 200032
Contact: Qinhui Fu, MD    +86-21-64385700 ext 3534    ff777315@163.com   
Sub-Investigator: Jun Wang, MD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Fudan University
Investigators
Study Chair: Jian Pei, MD Longhua Hospital Shanghai University of Traditional Chinese Medicine
Study Chair: Yi Wu, MD Huashan Hospital
Study Director: Jie Jia, MD Huashan Hospital
Study Director: Yi Song, MM Longhua Hospital Shanghai University of Traditional Chinese Medicine
Principal Investigator: Zouqin Huang, MM Longhua Hospital Shanghai University of Traditional Chinese Medicine
Principal Investigator: Xiaoxin You, MM Longhua Hospital Shanghai University of Traditional Chinese Medicine
Principal Investigator: Qinhui FU, MD Longhua Hospital Shanghai University of Traditional Chinese Medicine
Principal Investigator: Jun Wang, MM Longhua Hospital Shanghai University of Traditional Chinese Medicine
  More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01806233     History of Changes
Other Study ID Numbers: 3534123123
Study First Received: February 26, 2013
Last Updated: January 29, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Ischemia
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017