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

NHS Tayside

Status: Completed

Conditions: Accidental Falls

Treatments: Other: Foot and ankle exercises, foot orthoses, footwear provision; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02178527

2010GR10

CZH/4/701 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups, including a placebo group

Mulitfaceted podiatry Intervention

Experimental group

Description:

Foot and ankle exercises, foot orthoses, footwear provision

Treatment:

Other: Foot and ankle exercises, foot orthoses, footwear provision

Usual podiatry care

Placebo Comparator group

Description:

Continued provision of usual NHS (National Health Service) podiatry care

Treatment:

Other: Usual Care