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ISRCTN
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ISRCTN34844778
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ClinicalTrials.gov identifier
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Public title
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A Preliminary Investigation Into The Effect Of Home Standing Programs On Lower Limb Spasticity, Spasm, Pain and Well-being For Individuals With Progressive Multiple Sclerosis (MS)
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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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N0515143146
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Study hypothesis
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The principal research questions are that daily standing in a frame will:
1. Decrease passive resistance to movement in lower limb (lower limb stiffness know as hyper tonicity)
2. Enhance range of motion at ankles.
3. Decrease frequency of lower limb spasms.
4. Lead to self-reported decrease in pain.
5. Lead to self-reported improvement in well-being.
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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 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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Nervous System Diseases: Multiple sclerosis (MS)
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Participants - inclusion criteria
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Participants are to be identified from clinical team members (physiotherapists) working in either Harrow PCT, Northwick Park Hospital or Harrow MS Therapy Centre.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/2004
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Anticipated end date
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01/05/2005
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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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The study proposed to use a cross over design of a minimum of six participants with primary or secondary MS these participants will be randomly selected to either a three-week exercise group or a three week standing group. The participants in the standing group will stand daily in a Standing Frame for 30 minutes if able. These participants will be shown how to use and stand in the frame, given exercises to perform whilst standing and show how to correctly position themselves in the frame. Preliminary research results will be feedback to the participants at the end of the six week study period. They will also be informed that final results will be available from the researchers , and the local MS society will also be made aware of the results. Measurements will be taken at assessment, three and six weeks, with the groups crossing over after three weeks.
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Primary outcome measure(s)
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Not provided at time of registration
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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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North West London Hospitals NHS Trust
Unfunded
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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Miss
Karen
Baker
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Address
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Physical Disability Support Team
North West London Hospitals NHS Trust
P Block Northwick Park Hospital
Watford Road
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City/town
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Harrow
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Zip/Postcode
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HA1 3UJ
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Country
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United Kingdom
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Tel
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+44 (0)20 8869 3636
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Fax
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+44
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Email
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karen_baker73@yahoo.co.uk
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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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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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03/10/2005
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Date ISRCTN assigned
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30/09/2005
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