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ISRCTN
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ISRCTN99172250
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ClinicalTrials.gov identifier
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Public title
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Strength training with Electrical Stimulation - is this a viable method of facilitating independent mobility and improving quality of life after a moderate to severe stroke?
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Scientific title
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Strength training with Electrical Stimulation: a randomised controlled trial of a viable method of facilitating independent mobility and improving quality of life after a moderate to severe stroke
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Acronym
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N/A
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Serial number at source
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AP1131
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Study hypothesis
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To develop a therapy protocol to prevent deterioration of muscle performance after a moderate to severe stroke.
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Lay summary
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Ethics approval
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South Manchester (Northwest 6- GM South) Research Ethics Committee approved on the 4th August 2008 (ref: 08/H1003/44)
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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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1. Below age of 80 years, either sex
2. Medically stable
3. Capable of providing informed consent
4. Patients who can sit and transfer independantly, however who are unable to mobilise
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Participants - exclusion criteria
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Contraindication to electrical stimulation (i.e., orthopaedic implants at stimulation site, active cardiac implants, and skin reactions to electrodes)
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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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20/08/2009
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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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10 acute stroke patients: 5 treatment, 5 control
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Interventions
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Treatment:
Six weeks treatment, three times per week with electrical stimulation on quadriceps, and gastrocnemius, combined with standard NHS therapy treatment.
Control:
Six weeks of monitoring progress after standard NHS therapy treatment.
There will be a measurement at the end of treatment but no further follow-up.
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Primary outcome measure(s)
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Muscle strength, measured at 0, 3 and 6 weeks
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Secondary outcome measure(s)
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Measured at 0, 3 and 6 weeks:
1. Electromyography
2. Range of movement
3. Magnetic Resonance Imaging (MRI) of muscle volume
4. Ultrasound imaging for muscle architecture
5. Barthel Index
6. Nottingham Extended Activities of Daily Living (NEADL)
7. Visual analogue scale
8. Fatigue severity scale
9. Timed up and go
10. 10-metre walk
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Sources of funding
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Action Medical Research (UK) (ref: AP1131)
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Trial website
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Publications
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Contact name
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Dr
Anand
Pandyan
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Address
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School of Health and Rehabilitation
Keele University
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City/town
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Staffordshire
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Zip/Postcode
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ST5 5GB
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Country
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United Kingdom
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Sponsor
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Keele University (UK)
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Address
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School of Health and Rehabilitation
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City/town
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Staffordshire
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Zip/Postcode
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ST5 5GB
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Country
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United Kingdom
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Sponsor website:
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http://www.keele.ac.uk/
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Date applied
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21/09/2009
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Last edited
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28/09/2009
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Date ISRCTN assigned
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28/09/2009
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