Clinical Trials Directory

Trials / Completed

CompletedNCT02178527

Podiatry Intervention to Reduce Falls in Elderly Care Trial (PIRFECT)

A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
NHS Tayside · Other Government
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERFoot and ankle exercises, foot orthoses, footwear provisionParticipants in the intervention group will receive orthoses and footwear as part of the study. The research team will train care home staff in the provision of foot and ankle exercises. The exercise protocol states that exercises will be carried out 3 times per week for 12 weeks.
OTHERUsual CareUsual general podiatry care provded by UK National Health Service

Timeline

Start date
2013-01-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2014-06-30
Last updated
2015-10-12

Locations

9 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02178527. Inclusion in this directory is not an endorsement.