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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01806233
Other study ID # 3534123123
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date December 2021

Study information

Verified date August 2021
Source Shanghai University of Traditional Chinese Medicine
Contact Jian Pei, MD
Phone 021-64385700
Email jianpei99@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China Longhua Hospital,Shanghai University of Traditional Chinese Medicine Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Simplified Fugl-Meyer Scale 5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks 8 weeks
Secondary Burden of Stroke Scale-Boss 5 times a week, last 4 weeks,assessment on 8 weeks and 6 months 6 months
Secondary Modified Barthel Index 5 times a week, last 4 weeks,assessment on 8 weeks and 6 months 6 months
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