Accidental FallsPIRFECTNCT02178527
Podiatry Intervention to Reduce Falls in Elderly Care Trial (PIRFECT)
A study testing Foot and ankle exercises, foot orthoses, footwear provision in people with Accidental Falls, run by NHS Tayside at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Foot and ankle exercises, foot orthoses, footwear provision
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Glencairn House Care Home
Auchterarder, PH3 1AD
Ancaster Care Home
Crieff, PH7 3JU
Harestane Care Home
Dundee, DD3 0NY
Janet Brougham House
Dundee, DD4 7TQ
Balcarres Care Home
Dundee, DD5 1NW
Orchar Care Home
Dundee, DD5 2BG
Rivendell Care Home
Dunkeld, PH8 0BL
Craigieknowes Care Home
Perth, PH2 0DG
Kincarrathie House Care Home
Perth, PH2 7HX
About this study
Official title: A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
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
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- Foot and ankle exercises, foot orthoses, footwear provision, Usual Care
- Keywords
- Geriatrics, Accidental Falls, Podiatry, Exercise Therapy, Orthotic Devices, Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot and ankle exercises, foot orthoses, footwear provisionOther
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 CareOther
Usual general podiatry care provded by UK National Health Service
| Study group | Role | What they receive |
|---|---|---|
| Mulitfaceted podiatry Intervention | Experimental | Foot and ankle exercises, foot orthoses, footwear provision Receives: Other: Foot and ankle exercises, foot orthoses, footwear provision |
| Usual podiatry care | Placebo comparator | Continued provision of usual NHS (National Health Service) podiatry care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Secondary outcomes (6)
Functional Balance: Berg Balance Scale
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Mobility: Timed up and go test
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Physical Functioning: Barthel Index
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Health Related Quality of Life: EQ-5D
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Foot and Ankle Strength
Measured via hand held dynamometry
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Falls efficacy: Nursing home falls self efficacy scale
Measured: Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Collaborators
- University of Stirling, La Trobe University, University of Toronto, University of Dundee
- Responsible party
- Principal investigator, Gavin Wylie, NHS Tayside
- Investigators
- Gavin H Wylie, MSc, Principal investigator, NHS (National Health Service) Tayside / University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178527
- Sponsor's protocol ID
- 2010GR10
- Other IDs
- CZH/4/701
- Acronym
- PIRFECT
- Status last verified
- Oct 2015
- First submitted
- 17 Jun 2014
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28701161
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02178527
- Acronym / sponsor ID
- PIRFECT / 2010GR10
- Conditions
- Accidental Falls
- Keywords
- Geriatrics, Accidental Falls, Podiatry, Exercise Therapy, Orthotic Devices, Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Collaborators
- University of Stirling, La Trobe University, University of Toronto, University of Dundee
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulitfaceted podiatry Intervention | Experimental | Other: Foot and ankle exercises, foot orthoses, footwear provisionFoot and ankle exercises, foot orthoses, footwear provision |
| Usual podiatry care | Placebo comparator | Other: Usual CareContinued provision of usual NHS (National Health Service) podiatry care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot and ankle exercises, foot orthoses, footwear provisionParticipants 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. | Other | Mulitfaceted podiatry Intervention |
| Usual CareUsual general podiatry care provded by UK National Health Service | Other | Usual podiatry care |
Primary outcome
Change in falls rate
Time frame: 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"
6 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 28701161Wylie 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin H Wylie, MSc principal investigator
NHS (National Health Service) Tayside / University of Dundee
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot and ankle exercises, foot orthoses, footwear provision in people with Accidental Falls, run by NHS Tayside at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in falls rate (time frame: 3 months from baseline measures, 6 months from baseline, 9 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.