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| ID | Type | Description | Link |
|---|---|---|---|
| CZH/4/701 | Other Grant/Funding Number | Chief Scientist Office, Scottish Goverment |
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| Name | Class |
|---|---|
| University of Stirling | OTHER |
| La Trobe University | OTHER |
| University of Toronto | OTHER |
| University of Dundee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mulitfaceted podiatry Intervention | Experimental | Foot and ankle exercises, foot orthoses, footwear provision |
|
| Usual podiatry care | Placebo Comparator | Continued provision of usual NHS (National Health Service) podiatry care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gavin H Wylie, MSc | NHS (National Health Service) Tayside / University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glencairn House Care Home | Auchterarder | PH3 1AD | United Kingdom | |||
| Ancaster Care Home |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28701161 | Derived | Wylie G, Menz HB, McFarlane S, Ogston S, Sullivan F, Williams B, Young Z, Morris J. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study). BMC Geriatr. 2017 Jul 12;17(1):143. doi: 10.1186/s12877-017-0541-1. |
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| OTHER |
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| Usual Care | Other | Usual general podiatry care provded by UK National Health Service |
|
| 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 |
| Crieff |
| PH7 3JU |
| United Kingdom |
| Harestane Care Home | Dundee | DD3 0NY | United Kingdom |
| Janet Brougham House | Dundee | DD4 7TQ | United Kingdom |
| Balcarres Care Home | Dundee | DD5 1NW | United Kingdom |
| Orchar Care Home | Dundee | DD5 2BG | United Kingdom |
| Rivendell Care Home | Dunkeld | PH8 0BL | United Kingdom |
| Craigieknowes Care Home | Perth | PH2 0DG | United Kingdom |
| Kincarrathie House Care Home | Perth | PH2 7HX | United Kingdom |
| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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