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ISRCTN
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ISRCTN23245449
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ClinicalTrials.gov identifier
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Public title
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Acupuncture for Established Stroke
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0203092386
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled clinical trial, 2 parallel arms
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Stroke
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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15/01/2001
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Anticipated end date
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31/03/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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152
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Interventions
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Randomised controlled clinical trial, 2 parallel arms.
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. 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. (Other outcome measures are Fugl-Meyer Assessment Scale, Ashworth spasticity Scale, 9-hole peg test, Timed 10-metre walk, and EuroQoL.)
AS OF SEPTEMBER 2005, STUDY NOT STARTED
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Royal Devon and Exeter NHS Trust
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Trial website
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16186474
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Contact name
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Dr
Jongbae
Park
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Address
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University of Exeter
Department of Complementary Medicine
25 Victoria Park Road
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City/town
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Exeter
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Zip/Postcode
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EX2 4NT
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Country
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United Kingdom
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Tel
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+44 (0)1392 439035
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Fax
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+44 (0)1392 424989
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Email
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Jongbae.Park@pms.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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14/12/2010
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Date ISRCTN assigned
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30/09/2004
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