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Completed

NCT Number: NCT02178527

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

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

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glencairn House Care Home, Auchterarder, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 Years or older permanently living in care homes for older people
  • One or more falls in the previous year.
  • Foot problem that is within the scope of podiatry care

Exclusion criteria

  • Residents who are terminally unwell or too frail to be included
  • Residents who are only able to mobilise with the use of a wheelchair
  • Temporary residents (for example, those in respite care)
  • Unable to provide informed consent
  • Lower limb Amputees

Treatment and study plan

Foot and ankle exercises, foot orthoses, footwear provision

Other

Participants 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.

Usual Care

Other

Usual general podiatry care provded by UK National Health Service

Primary outcomes

  1. Change in falls rate

    Time frame: 3 months from baseline measures, 6 months from baseline, 9 months from baseline

    A fall will be defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level"

Secondary outcomes

  1. Functional Balance: Berg Balance Scale

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

  2. Mobility: Timed up and go test

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

  3. Physical Functioning: Barthel Index

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

  4. Health Related Quality of Life: EQ-5D

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

  5. Foot and Ankle Strength

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

    Measured via hand held dynamometry

  6. Falls efficacy: Nursing home falls self efficacy scale

    Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline

Sponsors and collaborators

Lead sponsor

NHS Tayside

Other Gov

Collaborators

  • La Trobe University
  • University of Dundee
  • University of Stirling
  • University of Toronto

Registry information

Official study title

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

Acronym: PIRFECT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2014
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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