Condition category
Nervous System Diseases
Date applied
04/09/2016
Date assigned
18/10/2016
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off. Around 80% of strokes are ischemic strokes, in which the arteries that supply the brain with oxygen become narrowed or blocked, causing severely reduced blood flow (ischemia). This can lead to serious complications, depending on which part of the brain is deprived of oxygen and for how long. One of the most common long-term complications from stroke is weakness on one side of the body (hemiparesis). Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needels are placed into the body at specific points. Studies have shown that it can lead to an improvement in hemiparesis following stroke, however the exact mechanism for this is not known, in particular, whether it affects the movement centre of the brain. The aim of this study is to find out whether acupuncture is able to improve hemiparesis following stroke by affecting the movement centre of the brain.

Who can participate?
Adults who have had a stroke and are experiencing weakness in one hand.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive 40 acupuncture sessions over a period of 12 weeks as well as standard care. Those in second group undergo conventional physical therapy for stroke rehabilitation, involving exercises designed to help recover movement. At the start of the study and then after three months, participants in both groups have a brain scan to find out if the therapy they have had has led to changes in the movement centre of the brain. At the same time, participant’s hand function is assessed to find out if it has improved.

What are the possible benefits and risks of participating?
Participants may benefit from recovering movement lost following their stroke. The risks of receiving acupuncture or rehabilitation treatment described in this study are small. In few cases, acupuncture may cause discomfort or pain at the sites during needle insertion, and nausea or feeling faint after insertion. Rehabilitation may lead to muscle sprain, bruising or tiredness.

Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine (China)
2. China Rehabilitation Research Center (China)

When is the study starting and how long is it expected to run for?
December 2015 to June 2017

Who is funding the study?
Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding (China)

Who is the main contact?
Professor Linpeng Wang
wlp5558@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Linpeng Wang

ORCID ID

http://orcid.org/0000-0002-0775-9939

Contact details

Meishuguanhoujie No. 23
Dongcheng Province
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZYLX201412

Study information

Scientific title

Characterizing the neurophysiological mechanisms of acupuncture on motor functional recovery after stroke: a randomized controlled study

Acronym

Study hypothesis

Acupuncture exerts its positive effects on post-stroke motor behavior by influencing cortical plasticity.

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine, 24/03/2016, ref: 2016BL-018-01

Study design

Two-arm single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Motor dysfunction after stroke

Intervention

Participants who meet the eligibility criteria will be randomly assigned to one of the two groups in a 1:1 ratio. Randomization will be conducted using computer-generated random numbers placed in sequentially numbered, sealed opaque envelopes and kept by a clinician with no contact to study participants.

Both acupuncture and rehabilitation groups will receive a total of 40 treatment sessions in 12 weeks. Participants in both groups will receive standard medical care for stroke throughout the trial, which will be conducted in accordance with the China Guideline for the Diagnosis and Treatment of Acute Ischemic Stroke (2010).

The acupuncture group will additionally receive manual acupuncture for 12 weeks. Twelve acupoints will be used for all the patients. Each session will last for 40 minutes.

For the control group, patients will undergo conventional physical therapy. The structure of the intervention will be customized to each individual’s functional level. Each session will have a duration of 40 minutes.

Participants in both groups are followed up at the end of the intervention period (12 weeks), at which time they will undergo transcranial magnetic stimulation and motor function testing.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Excitability of primary motor cortex measured by recruitment curve of Motor Evoked Potential by transcranial magnetic stimulation at baseline and 3 months

Secondary outcome measures

1. Motor function of hand and arm are measured using the Action Research Arm Test and the upper-extremity portion of the Fugl-Meyer motor assessment at baseline and 3 months
2. General motor disability is measured using the modified Rankin scale at baseline and 3 months
3. Neurological deficit is measured using National Institutes of Health Stroke Scale assessment at baseline and 3 months
4. The muscle strength level is measured using the UK Medical Research Council standard at baseline and 3 months

Overall trial start date

01/12/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. First-ever mono-hemispheric ischemic stroke
2. Within 14 days after stroke onset
3. Hand weakness with MRC level of 1 to 4
4. Aged between 18 and 80

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Participation in other medical studies at present or during the previous 3 months
2. Pre-existing conditions of body dysfunction before stroke attack
3. Pregnancy
4. Cognitive or communication impairment or pre-existing conditions precluding informed consent or compliance with study assessments

Recruitment start date

01/09/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine
Meishuguanhoujie No. 23 Dongcheng Province
Beijing
100010
China

Trial participating centre

China Rehabilitation Research Center
Jiaomenbeilu no.10 Fengtai province
Beijing
100068
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine

Sponsor details

Meishuguanhoujie no. 23
Dongcheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study is about to be presented in an original study paper and published in the second half of 2017.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes