Accidental Falls
Conditions
Keywords
Geriatrics, Accidental Falls, Podiatry, Exercise Therapy, Orthotic Devices, Foot
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.
Interventions
OTHERFoot and ankle exercises, foot orthoses, footwear provision
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.
OTHERUsual Care
Usual general podiatry care provded by UK National Health Service
Sponsors
University of Stirling
La Trobe University
University of Toronto
University of Dundee
NHS Tayside
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in falls rate | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Functional Balance: Berg Balance Scale | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | — |
| Foot and Ankle Strength | Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline | Measured via hand held dynamometry |
| Falls efficacy: Nursing home falls self efficacy scale | 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 | — |
Countries
United Kingdom
Outcome results
None listed