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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Accidental Falls

Intervention / Treatment
-----------------
* Other: Foot and ankle exercises, foot orthoses, footwear provision
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mulitfaceted podiatry Intervention<br>Foot and ankle exercises, foot orthoses, footwear provision | Other: Foot and ankle exercises, foot orthoses, footwear provision<br>* 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.<br>|
| Placebo Comparator: Usual podiatry care<br>Continued provision of usual NHS (National Health Service) podiatry care | Other: Usual Care<br>* Usual general podiatry care provded by UK National Health Service<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in falls rate | A fall will be defined as an unexpected event in which the participant comes to rest on the ground, floor, or lower level | 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Balance: Berg Balance Scale |  | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 
| Mobility: Timed up and go test |  | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 
| Physical Functioning: Barthel Index |  | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 
| Health Related Quality of Life: EQ-5D |  | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 
| Foot and Ankle Strength | Measured via hand held dynamometry | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 
| Falls efficacy: Nursing home falls self efficacy scale |  | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Geriatrics, Accidental Falls, Podiatry, Exercise Therapy, Orthotic Devices, Foot