Accidental Falls Clinical Trial
Official title:
A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of
a multifaceted podiatry intervention designed to reduce falls in care homes. The
investigators hypothesise that the intervention will reduce the high falls rates present in
care homes for older people, compared to usual care.
The results will inform the sample size calculation for a full-scale definitive RCT
Background: Falls are a problem in care homes where it is estimated that half of all
residents will fall at least once in a year. There is now strong empirical evidence that
weakness of the foot muscles and painful foot problems such as corns and/or callus are a
contributing factor to falls in this population. These problems are common and reversible;
however there have been no trials of podiatry interventions that address these problems to
establish whether or not this approach can be effective at reducing falls in care home
populations.
Methods: Care home residents meeting the inclusion criteria will be assigned to receive
either the intervention (specific foot and ankle exercises, orthoses, footwear). We will
then conduct an exploratory randomised controlled trial (RCT) with the aim of acquiring data
that will inform the design of a subsequent full scale RCT. The groups will then be compared
on a number of balance and falls related outcomes.
Main Outcome: The results will indicate the effect size to allow a sample size calculation
for a later definitive trial to be conducted.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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