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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01806233
First received: February 26, 2013
Last updated: December 25, 2013
Last verified: December 2013
  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 Phase
Ischemic Stroke
Paralysis
Procedure: Acupuncture
Procedure: Rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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: 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
acupuncture and moxibustion.
Procedure: Acupuncture
The treatment group:60 patients receive Acupuncture and Moxibusiton,choosing shenting(A)、baihui(A)、fengchi(A)、hanyan(A)、jianyu(A)、quchi(A)、waiguan(A)、zusanli(A)、fenglong(A)、xingjian yongquan(M),20minutes each once,ten time as a period of treatment,two periods of treatment in all.
Other Name: Acupuncture,Moxibusiton
Experimental: Rehabilitation
rehabilitation exercise
Procedure: Rehabilitation
The matched group:60 patients receive rehabilitation exercise,45 minutes each once,ten time as a period of treatment,two periods of treatment in all.
Other Name: Rehabilitation exercise

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
Genders Eligible for Study:   Both
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

Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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
  More Information

No publications provided

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: December 25, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014