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ISRCTN
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ISRCTN94187624
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ClinicalTrials.gov identifier
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Public title
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The effect of two different ankle-foot-orthoses on walking and quality of life in children with Hereditary Motor and Sensory Neuropathy (HMSN) - also known as Charcot-Marie Tooth (CMT) Disease.
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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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N0170141303
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Study hypothesis
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Do silicone ankle foot orthosis (AFOs) offer similar benefits to children with Hereditary Motor Sensory Neuropathy (HMSN) in terms of walking and Quality of Life measures as do traditional AFOs?
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Lay summary
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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 cross-over study
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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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Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease
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Participants - inclusion criteria
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1. Six children with Charcot-Marie Tooth disease
2. Children aged 4-16 with proven HMSN and therefore foot drop
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Participants - exclusion criteria
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Children with no foot drop.
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Anticipated start date
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15/05/2004
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Anticipated end date
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15/11/2005
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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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6
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Interventions
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Randomised cross-over study. Gait analysis performed in Human Performance Laboratory
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Primary outcome measure(s)
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The benefits of silicone over traditional AFOs
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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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Nottingham City Hospital NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
G
Chow
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Address
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Queen's Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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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 - 2005 Update - Department of Health (UK)
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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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Fax
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+44 (0)20 7307 2623
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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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30/09/2005
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Last edited
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19/04/2011
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Date ISRCTN assigned
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30/09/2005
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