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ISRCTN
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ISRCTN96487050
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ClinicalTrials.gov identifier
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Public title
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Upper limb retraining in stroke
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Scientific title
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A feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination, and manipulation in acute stroke
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Acronym
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N/A
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Serial number at source
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7511
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Study hypothesis
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Following stroke 30% patients have persistent motor deficits. There is growing evidence that augmenting exercise therapy time after stroke improves outcome. In practice, increasing therapy time demands costly increases in staffing. Robotic aids can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb.
Aim:
To conduct a feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation.
Methods:
Examination of 100 consecutive patients to establish the proportion of acute stroke patients could potentially benefit from rehabilitation using an aid.
Study outputs:
At the end of the study we will have identified the proportion of stroke patients who can use this robotic aid and the resource implications, the most responsive functional measure and the size of an appropriately powered control trial.
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Lay summary
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Ethics approval
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The National Hospital for Neurology and Neurosurgery & Institute of Neurology Joint REC approved in April 2008 (ref: 08/H0716/13)
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Study design
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Single centre randomised interventional treatment 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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Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used
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Participants - inclusion criteria
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1. Confirmed stroke
2. Capable of giving informed consent
3. One hundred consecutive stroke patients (all ages, either sex)
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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16/06/2009
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Anticipated end date
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01/06/2011
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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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Planned sample size: 100; UK sample size: 100
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Interventions
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The study is recruiting the first 100 stroke patients admitted to UCLH trusts. Subjects following consent to participate are to have baseline outcome measures taken. If participants have arm impairments these measures are retaken at 6 weeks or on discharge if earlier. Subjects with arm impairments are also assessed weekly to see if they can interface with a mock up of a robotic device.
Patients will be assessed by a physiotherapist seven days after admission and weekly for the first six weeks or until they are discharged whichever is the earlier. A final assessment will take place for all patients at six weeks.
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Primary outcome measure(s)
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Measured seven days after admission, then, weekly until 6 weeks:
1. Action Research Arm Test (ARAT)
2. Disabilities of Arm, Shoulder, Hand (DASH)
3. Chedoke Arm and Hand Inventory
4. Measure of manual ability for adults with upper limb impairments (ABILHAND)
5. Stroke Rehabilitation Assessment of Movement (STREAM)
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Secondary outcome measure(s)
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Measured seven days after admission, then, weekly until 6 weeks:
1. Barthel Index
2. European Quality of Life Questionnaire (EQ-5D)
3. 36-item Short Form Health Survey (SF36)
4. National Institutes of Health Stroke Scale (NIHSS)
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Sources of funding
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The Stroke Association (UK) (ref: TSA 2007/14)
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Trial website
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Publications
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Contact name
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Prof
Diane
Playford
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Address
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Multiple Sclerosis and NMR
National Hospital for Neurology and Neurosurgery
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Email
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d.playford@ion.ucl.ac.uk
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Sponsor
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National Hospital for Neurology and Neurosurgery (UK)
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Address
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Institute of Neurology
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Sponsor website:
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http://www.uclh.nhs.uk/Our+hospitals/National+Hospital+for+Neurology+and+Neurosurgery.htm
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Date applied
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28/05/2010
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Last edited
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15/11/2010
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Date ISRCTN assigned
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28/05/2010
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