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ISRCTN
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ISRCTN31849226
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ClinicalTrials.gov identifier
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Public title
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Promotion of cerebral plasticity by mirror therapy - evaluation of a new therapy approach for neurological rehabilitation
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Scientific title
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Effect of mirror therapy early after stroke: a randomised, single-blinded, placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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0315
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Study hypothesis
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Patients after a first-ever, single stroke in the middle cerebral artery (MCA) area show a significantly better outcome when treated for six weeks with additional mirror training compared to six weeks of additional training with a direct view of their affected hand.
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Lay summary
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Ethics approval
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Ethics Committee of the Physicians Chamber North Rhein (Arztekammer Nordrhein) (General Medical Council) approved on the 14th July 2004 (ref: 2004189)
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Study design
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Randomised single-blinded placebo-controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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First-ever, single stroke in the MCA territory not more than eight weeks prior to study inclusion
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Participants - inclusion criteria
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1. First ever, single stroke in the MCA territory not more than eight weeks prior to study inclusion
2. Aged 30 to 80 years
3. Severe hemiparesis
4. Cardiovascular stability for participation at several therapy units a day
5. Communication level allowing obedience to therapy protocol
6. Written informed consent
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Participants - exclusion criteria
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1. Multiple strokes
2. Significant hemorrhagic imbibition
3. Prior hemicranectomy
4. Restricted mobility of the upper extremity by orthopedic, rheumatologic or other concomitant disease
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Anticipated start date
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01/07/2004
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Anticipated end date
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31/08/2006
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Status of trial
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Completed |
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Patient information material
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Can be found at http://www.refonet.de/projekte/documents/Pat-Information-080924.pdf
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Target number of participants
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40
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Interventions
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Additional occupational therapy for six weeks (30 minutes a day, 5 days a week) - mirror training versus training with a direct view of the affected hand
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Primary outcome measure(s)
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Fugl Meyer (FM) score after six weeks of intervention
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Secondary outcome measure(s)
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1. Action research arm test (ARAT) score after six weeks of intervention
2. Functional independence measure (FIM) score after six weeks of intervention
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Sources of funding
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Refonet (Germany) (ref: 3015)
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Trial website
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http://www.spiegeltraining.de
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19074686
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Contact name
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Dr
Christian
Dohle
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Address
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MEDIAN Klinik Berlin
Department of Neurological Rehabilitation
Charite - University medicine Berlin
Campus Benjamin Franklin
Kladower Damm 223
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City/town
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Berlin
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Zip/Postcode
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D-14089
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Country
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Germany
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Tel
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+49 (0)30 36503 105/106
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Fax
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+49 (0)30 36503 123
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Email
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dohle.berlin@median-kliniken.de
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Sponsor
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Refonet (Germany)
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Address
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Burgweg 3
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City/town
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Bad Neuenahr-Ahrweiler
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Zip/Postcode
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D-53445
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Country
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Germany
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Tel
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+49 (0)264 190 620
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Fax
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+49 (0)264 190 6220
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Email
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service@refonet.de
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Sponsor website:
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http://www.refonet.de
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Date applied
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27/02/2006
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Last edited
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26/06/2009
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Date ISRCTN assigned
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22/03/2006
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