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ISRCTN
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ISRCTN71632550
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ClinicalTrials.gov identifier
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Public title
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Functional strength training to improve walking and upper limb function in stroke patients
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Scientific title
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Functional strength training to improve walking and upper limb function in people at least one year after stroke: a phase II trial
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Acronym
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N/A
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Serial number at source
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TSA 2008/08
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Study hypothesis
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The hypothesis is that providing functional strength training (FST) to people who are at least one year after stroke will improve motor function and ability to perform everyday functional activity. The first step towards testing this hypothesis in a definitive phase III clinical trial is to address the following questions:
1. Is there sufficient efficacy to justify subsequent trials of FST for upper and lower limb motor recovery in people at least one year after stroke?
2. Is FST delivered in the community acceptable to stroke survivors one year and more after stroke?
3. What is the probable recruitment rate to a subsequent phase III trial?
4. What sample size is needed for subsequent phase III trial (effect size, attrition rate, response variation)?
5. What cost-effectiveness data should be collected in subsequent trials?
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Lay summary
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Ethics approval
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Norfolk Ethics Committee, pending as of 12/01/2009.
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Study design
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Randomised placebo-controlled observer-blind phase II trial with embedded qualitative investigation
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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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1. Adults aged 18 years and above, either sex, one to five years after stroke in anterior circulation (infarct or haemorrhage) not receiving formal therapy for their upper or lower limb
2. Have a walking ability on the Functional Ambulatory Category between 1 and 49 and have some voluntary activity in the paretic upper limb scoring 12+/57 on the Action Research Arm Test but unable to complete the Nine Hole Peg Test in 50 seconds or less
3. Can follow a one-stage command, i.e. sufficient communication/orientation for interventions in this trial
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Participants - exclusion criteria
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Known pathology precluding them participating in functional strength training.
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Anticipated start date
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01/03/2009
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Anticipated end date
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01/03/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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58
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Interventions
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Functional strength training is ‘hands-off’ progressive resistive exercise during functional activity whilst directing participants’ attention to the activity being performed and providing appropriate verbal feedback to enhance knowledge of performance. FST is designed to increase ability to produce voluntary muscle force throughout joint range, increase ability to modulate force in muscles/muscle groups appropriate for the activity being trained and improve functional ability. Activities are progressed by increasing the number of repetitions, increasing range of joint motion required and increasing the load to be moved. Intervention will be provided by a Research Physiotherapist for 1 hour/day, 4 days/week. Portable equipment (e.g. free weights and steppers) will be used as appropriate. Participants will be encouraged to use the paretic limb (upper or lower as allocated) in everyday functional activity. Standardised treatment schedules will be used (as in our earlier trials) to record the amount and type of intervention provided (compliance).
FSTLL will focus on functional activities e.g. sit-to-stand using body weight as resistance and progressively lowering the height of the supporting surface as participants improve. Equipment such as portable steppers will be used as appropriate but only with physiotherapy supervision for safety reasons.
FSTUL will focus on reaching for, retrieval of and manipulation (use) of everyday objects for activities such as pouring water from a jug, opening jars and lacing a shoe.
Both treatment schedules will include resistive exercise to strengthen specific muscles/muscle groups where weakness is hampering functional activity. The scientific papers describing these treatment schedules are currently in preparation.
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Primary outcome measure(s)
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1. Functional Ambulatory Category for lower limb function
2. Action Research Arm Test for upper limb function
All measured on days 43 and 88.
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Secondary outcome measure(s)
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1. Modified Rivermead Mobility Index for lower limb function
2. Nine Hole Peg Test for upper limb function
All measured on days 43 and 88.
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Sources of funding
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The Stroke Association (UK) (ref: TSA 2008/08)
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Trial website
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Publications
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Contact name
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Dr
Jane
Cross
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Address
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School AHP
University of East Anglia
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Email
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j.cross@uea.ac.uk
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Sponsor
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The Stroke Association (UK)
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Address
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Stroke House
240 City Road
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City/town
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London
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Zip/Postcode
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EC1V 2PR
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Country
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United Kingdom
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Email
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research@stroke.org.uk
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Sponsor website:
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http://www.stroke.org.uk/
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Date applied
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12/01/2009
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Last edited
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30/01/2009
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Date ISRCTN assigned
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30/01/2009
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