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

Primary Purpose

Ischemic Stroke, Paralysis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Rehabilitation

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Longhua Hospital,Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Acupuncture

Rehabilitation

Arm Description

acupuncture

rehabilitation exercise

Outcomes

Primary Outcome Measures

Simplified Fugl-Meyer Scale

5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks

Secondary Outcome Measures

Burden of Stroke Scale-Boss

5 times a week, last 4 weeks,assessment on 8 weeks and 6 months

Modified Barthel Index

5 times a week, last 4 weeks,assessment on 8 weeks and 6 months

Full Information

NCT ID

NCT01806233

First Posted

February 26, 2013

Last Updated

August 10, 2021

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01806233

Brief Title

Lu's Acupuncture and Moxibustion Treatment on Stroke

Acronym

LAMTS

Official Title

Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Paralysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

acupuncture

Arm Title

Rehabilitation

Arm Type

Experimental

Arm Description

rehabilitation exercise

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Rehabilitation

Other Intervention Name(s)

Rehabilitation treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Simplified Fugl-Meyer Scale

Description

5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Burden of Stroke Scale-Boss

Description

5 times a week, last 4 weeks,assessment on 8 weeks and 6 months

Time Frame

6 months

Title

Modified Barthel Index

Description

5 times a week, last 4 weeks,assessment on 8 weeks and 6 months

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Pei, MD

Phone

021-64385700

Ext

3534

jianpei99@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Pei, MD

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yi Wu, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jie Jia, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yi Song, MM

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zouqin Huang, MM

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaoxin You, MM

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qinhui FU, MD

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jun Wang, MM

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Longhua Hospital,Shanghai University of Traditional Chinese Medicine

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qinhui Fu, MD

Phone

+86-21-64385700

Ext

3534

ff777315@163.com

First Name & Middle Initial & Last Name & Degree

Jun Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32733577

Citation

Xu J, Pei J, Fu QH, Zhan YJ. The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study. Evid Based Complement Alternat Med. 2020 Jul 15;2020:1520851. doi: 10.1155/2020/1520851. eCollection 2020.

Results Reference

derived

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Lu's Acupuncture and Moxibustion Treatment on Stroke

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