Acupuncture for Established Stroke

ISRCTN	ISRCTN23245449
DOI	https://doi.org/10.1186/ISRCTN23245449
Secondary identifying numbers	N0203092386

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jongbae Park
Scientific

University of Exeter
Department of Complementary Medicine
25 Victoria Park Road
Exeter
EX2 4NT
United Kingdom

Phone	+44 (0)1392 439035
Email	Jongbae.Park@pms.ac.uk

Study design	Randomised controlled clinical trial with 2 parallel arms
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	Is manual acupuncture superior to sham manual acupuncture for improving the recovery from stroke in respect of functional and psychological status when given to established cases? The objectives of this study are to compare the changes of outcomes of stroke patients between baseline and post-treatment, and 6 months follow up.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Stroke
Intervention	152 chronic stoke patients will be invited to participate. They will be randomly divided to manual acupuncture group and sham acupuncture group and will be given 12 manual acupuncture treatments (tailored by constitution) in 12 weeks. All subjects will be assessed 3 times: baseline assessment before randomisation, post-treatment, and 6 month follow-up.
Intervention type	Other
Primary outcome measure	Primary outcome of this study is changes of Action Research Arm Test between baseline and post-treatment. Data will be analysed by statistical procedure like the Mann-Whittney test.
Secondary outcome measures	Other outcome measures are Fugl-Meyer Assessment Scale, Ashworth spasticity Scale, 9-hole peg test, Timed 10-metre walk, and EuroQoL.
Overall study start date	15/01/2001
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	152
Key inclusion criteria	1. All patients of any age with stroke due to infarction or haemorrhage at any brain location scanned computed tomography (CT) or magnetic resonance imaging (MRI) 2. Physically capable of travelling to hospital for treatment 3. Giving informed consent.
Key exclusion criteria	1. Patients who do not have capacity to communicate and give consent 2. History of serious diseases such as cancer, auto-immune disease and Acquired Immunodeficiency Syndrome (AIDS) 3. Fear of needling 4. History of surgery under general anaesthetic within 6 months 4. Major bleeding diseases
Date of first enrolment	15/01/2001
Date of final enrolment	31/03/2004

University of Exeter

Exeter
EX2 4NT
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Government

Royal Devon and Exeter NHS Trust

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/09/2005		Yes	No