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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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Multifaceted Podiatry Intervention for Fall Prevention REFORM
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REFORM: A Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 70 years of age
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Topic
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Generic Relevance & Cross Cutting Themes (co-adopted by Primary Care)
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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EudraCT
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MREC N°
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UKCRN ID
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11038
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WHO ID
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Study Type
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Interventional
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Design Type
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Not specified
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Disease(s)
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All Diseases
Age and ageing
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Phase
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N/A
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Current Status
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Open
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Closure Date
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10/31/2013
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Global Sample Size
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1700
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Global Recruitment to Date
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 10% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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Yes, within lead country only
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Main Inclusion Criteria
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Cohort study:
1) Aged over 70 years
2) Provided informed consent and necessary baseline information
Pilot and Full trial:
1) Aged over 70 years
2) Has had one fall in the past 12 months or one fall in the past 24 months requiring hospitalisation.
3) Community dwelling.
4) The participant is willing to attend the podiatry clinic
5) The participant is willing to take part in the REFORM study
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Main Exclusion Criteria
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Cohort study exclusion criteria:
• Known life expectancy of less than six months
• Participants known to have dementia
• Participants known to have neuropathy
• Participants who have had a lower limb amputation
• Participants known to be chair or bed bound
Pilot and Full trial
Participants who are/with
1) Dementia
2) Neurodegenerative disorder
3) Do not complete the baseline or runin
data collection instruments adequately ie fails to return all monthly falls
diaries over a three month period or return baseline questionnaires.
4) Have a lower limb amputation or planned lower limb surgery within the three months following the planned initial
assessment
5) Unable to walk household distances (10 metres) unaided.
6) Currently wearing a full or ¾ length inshoe
foot orthotic with the purpose of altering or modifying foot function in
order to treat, adjust and support various biomechanical foot disorders.
7) Unable to read or speak English
8) Usual footwear has been adapted in such a way which would not allow an orthotic to be fitted.
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Chief Investigator(s)
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| Prof David Torgerson |
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Further details, please contact
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Prof David Torgerson
University of York
Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
Heslington
York
North Yorkshire
YO10 5DD
UNITED KINGDOM
Tel: 01904 321340
david.torgerson@york.ac.uk
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| Funder(s) |
NIHR Health Technology Assessment
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| Sponsor(s) |
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