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ISRCTN
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ISRCTN49538372
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ClinicalTrials.gov identifier
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Public title
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An investigation into the effect of including a goal orientated independently practised exercise programme in early stroke rehabilitation
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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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N0647150885
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Study hypothesis
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To evaluate the effects of goal orientated individualised exercise and activity programmes practised independently in the first three months of stroke in addition to normal therapy, both from the perspective of the patient and the clinicians evaluation of the patients performance. To pilot the intervention to establish evidence for or against the feasibility of including independentluy practised goal orientated exercise programmes in early stroke rehabilitation. The results of the study, if positive, will inform a power calculation and design of a full randomised controlled trial.
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Lay summary
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Not provided at time of registration
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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 trial
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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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Stroke
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Participants - inclusion criteria
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Patients admitted to stroke ward and medically able to understand and comply with the protocol. Inclusion criteria:
1. In patients within 6 weeks of diagnosis fo first stroke confirmed by computed tomography (CT) scan
2. Medically stable and undergoing rehabilitation on a stroke and neurological unit
3. In the opinion of the research, have the ability to understand and comply with carrying out an exercise and activity programme on their own
4. Patients must be able to give informed consent
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Participants - exclusion criteria
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1. Complex medical problems that prevent compliance with study protocol
2. The patient is likely to be discharged within two weeks of admission to the stroke and neurological unit
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Anticipated start date
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01/05/2003
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Anticipated end date
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01/11/2003
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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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16 to 20 patients to be recruited during the six months of the study
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Interventions
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A single blinded RCT pilot using blocked randomisation in blocks of 4. Goal orientated individualised exercise and activity programmes practised independently in the first three months of stroke in addition to normal therapy.
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Primary outcome measure(s)
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1. Canadian Occupational Performance Measure (COPM)
2. Motor Assessment Scale (MAS)
3. Barthel Index
4. Patient diary
5. Patient telephone questionnaire
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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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1. Pan-Bath and Swindon Primary Care Research Collaborative (UK)
2. NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Ms
Judith
McLain
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Address
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Swindon Intermediate Care Centre
Downs Way
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City/town
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Swindon
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Zip/Postcode
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SN3 6BW
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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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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29/09/2006
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Last edited
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13/10/2011
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Date ISRCTN assigned
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29/09/2006
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