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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
47
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 general podiatry care provded by UK National Health Service
Glencairn House Care Home
Auchterarder, United Kingdom
Ancaster Care Home
Crieff, United Kingdom
Harestane Care Home
Dundee, United Kingdom
Janet Brougham House
Dundee, United Kingdom
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"
Time frame: 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Functional Balance: Berg Balance Scale
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Mobility: Timed up and go test
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Physical Functioning: Barthel Index
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Health Related Quality of Life: EQ-5D
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Foot and Ankle Strength
Measured via hand held dynamometry
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Falls efficacy: Nursing home falls self efficacy scale
Time frame: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
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