Clinical trial NCT01806233: Lu's Acupuncture and Moxibustion Treatment on Stroke
Official title: Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Paralysis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2013-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Simplified Fugl-Meyer Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Burden of Stroke Scale-Boss
timeFrame: 6 months
measure: Modified Barthel Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei, MD
role: STUDY_CHAIR
affiliation: Huashan Hospital
name: Yi Wu, MD
role: STUDY_CHAIR
affiliation: Huashan Hospital
name: Jie Jia, MD
role: STUDY_DIRECTOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yi Song, MM
role: STUDY_DIRECTOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Zouqin Huang, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Xiaoxin You, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Qinhui FU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jun Wang, MM
role: PRINCIPAL_INVESTIGATOR
References:
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.