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ISRCTN
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ISRCTN34651260
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ClinicalTrials.gov identifier
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Public title
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Can treatment with electrical stimulation help the recovery of arm function in stroke patients?
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Scientific title
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Can surface neuromuscular electrical stimulation (sNMES) of the wrist and hand, in conjunction with routine therapy, facilitate recovery of arm function in people with poor prognostic indicators of functional recovery?
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Acronym
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N/A
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Serial number at source
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AP0993
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Study hypothesis
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Primary objective:
Investigate whether treatment with surface neuromuscular electrical stimulation (sNMES) can facilitate recovery of arm function in people with poor prognostic indicators of arm function.
Secondary objectives:
Investigate whether treatment with sNMES will prevent the development of flexion contractures at the wrist and fingers and the development of upper limb pain, improve quality of life and reduce carer burden and costs (service and patient) associated with the long-term management of stroke patients.
As of 09/01/2009 this record was updated with further information provided by the principal investigator. All amendments can be found under the relevant field with the above update date. Please note that at this time a public title was added to this trial, and the previous scientific title has been moved to the correct location. Please also note that the age and gender of participants was added to the inclusion criteria at this time.
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Lay summary
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Ethics approval
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Added 09/01/2009: University Hospital North Staffordshire approved on the 30th June 2004 (ref: 04/Q2604/1)
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Study design
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Single blind randomised active controlled trial (RCT) with independent assessor
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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 with no measurable arm function
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Participants - inclusion criteria
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All adult patients (over the age of 18 years, either sex) with a first stroke who have no recovery of arm function (defined as a score of 0 in the "Grasp" sub-section of the Action Research Arm Test [ARAT]) at 4 weeks and no contraindication to sNMES.
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Participants - exclusion criteria
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Added 09/01/2009:
1. Medically unstable
2. A previous medical history of osteoarthritis, rheumatoid arthritis or soft tissue injuries that have resulted in contractures or reduced range of movement in the wrist and fingers
3. Informed consent or relatives' assent cannot be obtained or is refused
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Anticipated start date
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01/09/2004
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Anticipated end date
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31/05/2006
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Status of trial
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Completed |
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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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90
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Interventions
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Control:
Routine hand therapy (for six weeks from recruitment).
Treatment:
Routine therapy (as above) and treatment with surface electrical stimulation to the wrist extensors (three 30-minute sessions a day for six weeks).
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Primary outcome measure(s)
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Change in the Action Research Arm Test score at recruitment (2 - 4 weeks post-stroke) and at the end of study (one year post-stroke)
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Secondary outcome measure(s)
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Added 09/01/2009:
1. Pain
2. Isometric wrist strength
3. Contractures (measured as increased resistance to passive movement)
4. Spasticity (assessed by EMG)
5. "Patient" and "Carer" Burden scores
6. Neglect, monitored using the star cancellation test
Measured at baseline (recruitment), 6 weeks, 12 weeks, 24 weeks and 36 weeks.
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Sources of funding
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Action Medical Research (UK)
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Trial website
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http://www.action.org.uk/research_projects/grant_detail.php?id=236
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19052249
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Contact name
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Dr
Anand
Pandyan
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Address
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Department of Physiotherapy Studies
Mackay Building
Keele University
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City/town
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Keele
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Zip/Postcode
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ST5 5BG
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Country
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United Kingdom
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Tel
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+44 (0)1782 584252
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Fax
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+44 (0)1782 584255
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Email
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a.d.pandyan@keele.ac.uk
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Sponsor
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University Hospital Of North Staffordshire NHS Trust (UK)
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Address
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Medical Research Unit
Thornburrow Drive
Hartshill
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City/town
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Stoke-on-Trent
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Zip/Postcode
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ST4 7QB
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Country
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United Kingdom
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Sponsor website:
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http://www.uhns.nhs.uk
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Date applied
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22/09/2004
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Last edited
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07/01/2010
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Date ISRCTN assigned
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24/02/2005
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