Lu's Acupuncture and Moxibustion Treatment on Stroke

Ischemic Stroke Clinical Trial

— LAMTS  

Official title:

Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01806233
• Other study ID #: 3534123123
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Paralysis
• Stroke

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