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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: April 18, 2016
Last verified: March 2016

February 26, 2013
April 18, 2016
March 2013
December 2016   (final data collection date for primary outcome measure)
Simplified Fugl-Meyer Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks
  • Simplified Fugl-Meyer Scale [ Time Frame: after one course(10 times) ] [ Designated as safety issue: No ]
    10 times a course,it will last 20 days.
  • Modified Barthel Index [ Time Frame: after one courses(10 times) ] [ Designated as safety issue: No ]
    10 times a course,it will last 20 days.
  • Burden of Stroke Scale-Boss [ Time Frame: after one course(10 times) ] [ Designated as safety issue: No ]
    10 times a course,it will last 20 days.
Complete list of historical versions of study NCT01806233 on ClinicalTrials.gov Archive Site
  • Burden of Stroke Scale-Boss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
  • Modified Barthel Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
  • Simplified Fugl-Meyer Scale [ Time Frame: after two courses(20 times) ] [ Designated as safety issue: No ]
    after 40 days
  • Modified Barthel Index [ Time Frame: after two courses(20 times) ] [ Designated as safety issue: No ]
    after 40 days
  • Burden of Stroke Scale-Boss [ Time Frame: after two courses(20 times) ] [ Designated as safety issue: No ]
    after 40 days
Not Provided
  • Simplified Fugl-Meyer Scale [ Time Frame: 3 monthes after two courses ] [ Designated as safety issue: No ]
  • Modified Barthel Index [ Time Frame: 3 months after two courses ] [ Designated as safety issue: No ]
  • Burden of Stroke Scale-Boss [ Time Frame: 3 months after two courses ] [ Designated as safety issue: No ]
  • Simplified Fugl-Meyer Scale [ Time Frame: 6 months after two courses ] [ Designated as safety issue: No ]
  • Modified Barthel Index [ Time Frame: 6 months after two courses ] [ Designated as safety issue: No ]
  • Burden of Stroke Scale-Boss [ Time Frame: 6 months after two months ] [ Designated as safety issue: No ]
 
Lu's Acupuncture and Moxibustion Treatment on Stroke
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.
There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemic Stroke
  • Paralysis
  • 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.
  • 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
  • Experimental: Acupuncture
    acupuncture
    Intervention: Procedure: Acupuncture
  • Experimental: Rehabilitation
    rehabilitation exercise
    Intervention: Procedure: Rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
40 Years to 70 Years
No
Contact: Jian Pei, MD 021-64385700 ext 3534 jianpei99@yahoo.com
China
 
NCT01806233
3534123123
Yes
No
Not Provided
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Fudan University
Study Chair: Jian Pei, MD Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Study Chair: Yi Wu, MD Huashan Hospital, Fudan University
Study Director: Jie Jia, MD Huashan Hospital,Fudan University
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
Shanghai University of Traditional Chinese Medicine
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP