Postural BalanceNCT01132963
The Effects of Footwear on Balance and Confidence in Older Inpatients
A study testing Outdoor Shoes and Pillow Paw Slippers in people with Postural Balance and Accidental Falls, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
Trial summary
The study aims to assess whether type of footwear worn changes the balance, mobility and confidence of older inpatients and consequently may affect their falls risk whilst in hospital. The investigators hope to identify which footwear type is most beneficial to patients in the ward environment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postural Balance, Accidental Falls
- What is being tested?
- Outdoor Shoes and Pillow Paw Slippers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2010to Nov 2010
- 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
- Appropriate footwear
- Over 65 years
- Able to stand independently
- Inpatient in an acute geriatric assessment or rehabilitation ward
Who cannot join
- Unable to stand independently
- Acutely unwell
- Terminally unwell
- Registered partially sighted or blind
- Using lower limb orthotic device
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Stobhill Hospital
Glasgow, Lanarkshire, G21 3UW
Claire Steel, MBChB MRCP
Glasgow Royal Infirmary
Glasgow, Lanarkshire, G4 0SF
Alison Craig, MBChB MRCP
Mansionhouse Unit, Victoria Infirmary
Glasgow, Lanarkshire, G41 3DX
Jennifer Tilston, MBChB MRCP
Southern General Hospital
Glasgow, Lanarkshire, G51 4TF
Steven Wishart, MBChB MRCP
About this study
Official title: A Prospective Randomised Crossover Study to Evaluate the Effect Different Footwear Type Has on Measures of Balance and Confidence in Older Hospital Inpatients
The study aims to assess whether type of footwear worn changes the balance, mobility and confidence of older inpatients and consequently may affect their falls risk whilst in hospital. The investigators hope to identify which footwear type is most beneficial to patients in the ward environment.
Read the detailed description
Footwear is known to be one of many recognised significant risk factors for falls, presumably by affecting balance and gait pattern. However, little is known regarding the best footwear for hospital inpatients in whom approximately 40% of older persons fall during their hospital admission. Patients admitted to hospital without their own footwear (slippers or shoes) are routinely given foam slippers referred to as pillow paws (PPs). There are concerns that these PPs may contribute to falls as they are often ill fitting (come in a very limited size range) and or are flimsy offering little foot and ankle support. Hence Medicine for the Elderly consultant and registrars designed this study to gain information on differences in balance, mobility and confidence when patients are wearing different footwear types. As a secondary outcome, falls data will also be collected to see whether there is any association between footwear types and inpatient falls incidence.
The aim is to compare pillow paws (PPs) with sturdy outdoor footwear or sturdy slippers. In this way we hope to gain information on which footwear type is most beneficial to hospital inpatients. A recent similar study infers that sturdy outdoor footwear benefits outpatients, but it is not clear whether the same applies to a hospital inpatient population whom are often frailer with greater co-morbidities (physical and mental) and a higher falls risk.
- Conditions
- Postural Balance, Accidental Falls
- Being tested
- Outdoor Shoes, Pillow Paw Slippers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor ShoesOther
Patient will be wearing sturdy outdoor shoes to complete balance tests
Pillow Paw SlippersOther
Patient will be wearing Pillow Paws slippers to complete balance tests which are issued to patients who do not have shoes in NHS hospitals in the UK
| Study group | Role | What they receive |
|---|---|---|
| Outdoor Shoes | Experimental | Patient will be asked to do balance tests while wearing outdoor shoes. Receives: Other: Outdoor Shoes |
| Pillow Paws Slippers | Active comparator | Patient will be asked to complete balance tests while wearing standard hospital issue 'Pillow Paw' slippers on their feet Receives: Other: Pillow Paw Slippers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Reach (centimeters)
Functional reach (FR):This is a measure of balance routinely performed on rehabilitation wards.
The patient stands against a wall with one shoulder touching the wall and that arm fully extended horizontally. A mark is made on the wall recording the furthest point they are reaching to. They are then asked to stretch this arm as far forwards as they can without overbalancing/ stepping forwards. Another mark is made recording this maximum stretching distance. The difference between the 2 marks (in cm) is FR.
Measured: Day 1 (at time of single assessment)
Timed Get-Up-And-Go (seconds)
Timed Get-Up-And-Go (TUG):- This is a measure of mobility that is recommended in guidelines for General Practitioners and hospital clinicians to perform as part of a simple falls risk assessment. The patient is timed on how long (IN SECONDS)it takes them to rise from a standard arm chair, walk to a line on the floor approx 10 feet away from chair, turn and return to the chair and sit back down.
Measured: Day 1 (at time of single assessment)
The 4-point bedside balance score (0-4)
The 4-point bedside balance score:- This also assesses participants' balance. The patient's ability to stand with feet together, then with one foot slightly in front of the other (ie. standing partially heel to toe), followed by standing with one foot directly in front of the other (ie. standing fully heel to toe) and then standing on one leg is recorded. Increasing points are scored for each movement completed successfully. If it is clear that a patient cannot complete a particular movement, then the next level up in difficulty is not attempted.
Measured: Day 1 (at time of single assessment)
Short Falls Efficiency Scale - International Questionnaire (score 7-28 points)
Short Falls Efficiency Scale - International (Short FES-I questionnaire) The patient will then be asked questions from the Short FES-I questionnaire. This asks the patient how concerned they would be about falling in the two footwear types in seven different situations. This is important to assess the influence footwear has on confidence.
Measured: Day 1 (at time of single assessment)
Secondary outcomes (1)
Incidence of falls during inpatient hospital stay
Any falls occurring during the participant's hospital stay will be recorded along with information on footwear worn at time of fall. This information can be accessed through NHS DATIX computerised incident reporting system.
Measured: Variable - duration of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Investigators
- Elizabeth Burleigh, MBChB MRCP, Study director, NHS Greater Glasgow and ClydeAlison Craig, MBChB MRCP, Principal investigator, NHS Greater Glasgow and ClydeClaire Steel, MBChB MRCP, Principal investigator, NHS Greater Glasgow and ClydeJennifer Tilston, MBChB MRCP, Principal investigator, NHS Greater Glasgow and ClydeLynsey Fielden, MBChB MRCP, Principal investigator, NHS Greater Glasgow and ClydeSteven Wishart, MBChB MRCP, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132963
- Sponsor's protocol ID
- GN09GE487
- Status last verified
- Mar 2010
- First submitted
- 27 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Menz HB, Lord SR. Footwear and postural stability in older people. J Am Podiatr Med Assoc. 1999 Jul;89(7):346-57. doi: 10.7547/87507315-89-7-346.
PubMed 10423940Horgan NF, Crehan F, Bartlett E, Keogan F, O'Grady AM, Moore AR, Donegan CF, Curran M. The effects of usual footwear on balance amongst elderly women attending a day hospital. Age Ageing. 2009 Jan;38(1):62-7. doi: 10.1093/ageing/afn219. Epub 2008 Nov 11.
PubMed 19001558Lord SR, Bashford GM. Shoe characteristics and balance in older women. J Am Geriatr Soc. 1996 Apr;44(4):429-33. doi: 10.1111/j.1532-5415.1996.tb06416.x.
PubMed 8636591Jessup RL. Foot pathology and inappropriate footwear as risk factors for falls in a subacute aged-care hospital. J Am Podiatr Med Assoc. 2007 May-Jun;97(3):213-7. doi: 10.7547/0970213.
PubMed 17507530Burns SL, Leese GP, McMurdo ME. Older people and ill fitting shoes. Postgrad Med J. 2002 Jun;78(920):344-6. doi: 10.1136/pmj.78.920.344.
PubMed 12151688Fortinsky RH, Iannuzzi-Sucich M, Baker DI, Gottschalk M, King MB, Brown CJ, Tinetti ME. Fall-risk assessment and management in clinical practice: views from healthcare providers. J Am Geriatr Soc. 2004 Sep;52(9):1522-6. doi: 10.1111/j.1532-5415.2004.52416.x.
PubMed 15341555Menant JC, Steele JR, Menz HB, Munro BJ, Lord SR. Effects of footwear features on balance and stepping in older people. Gerontology. 2008;54(1):18-23. doi: 10.1159/000115850. Epub 2008 Feb 4.
PubMed 18253023Tencer AF, Koepsell TD, Wolf ME, Frankenfeld CL, Buchner DM, Kukull WA, LaCroix AZ, Larson EB, Tautvydas M. Biomechanical properties of shoes and risk of falls in older adults. J Am Geriatr Soc. 2004 Nov;52(11):1840-6. doi: 10.1111/j.1532-5415.2004.52507.x.
PubMed 15507060Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. doi: 10.1159/000086373.
PubMed 16110238Koepsell TD, Wolf ME, Buchner DM, Kukull WA, LaCroix AZ, Tencer AF, Frankenfeld CL, Tautvydas M, Larson EB. Footwear style and risk of falls in older adults. J Am Geriatr Soc. 2004 Sep;52(9):1495-501. doi: 10.1111/j.1532-5415.2004.52412.x.
PubMed 15341551
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Crossover Study to Evaluate the Effect Different Footwear Type Has on Measures of Balance and Confidence in Older Hospital Inpatients
- ClinicalTrials.gov ID
- NCT01132963
- Acronym / sponsor ID
- GN09GE487
- Conditions
- Postural Balance, Accidental Falls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 28 May 2010 (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.
The study aims to assess whether type of footwear worn changes the balance, mobility and confidence of older inpatients and consequently may affect their falls risk whilst in hospital. The investigators hope to identify which footwear type is most beneficial to patients in the ward environment.
Detailed description
Footwear is known to be one of many recognised significant risk factors for falls, presumably by affecting balance and gait pattern. However, little is known regarding the best footwear for hospital inpatients in whom approximately 40% of older persons fall during their hospital admission. Patients admitted to hospital without their own footwear (slippers or shoes) are routinely given foam slippers referred to as pillow paws (PPs). There are concerns that these PPs may contribute to falls as they are often ill fitting (come in a very limited size range) and or are flimsy offering little foot and ankle support. Hence Medicine for the Elderly consultant and registrars designed this study to gain information on differences in balance, mobility and confidence when patients are wearing different footwear types. As a secondary outcome, falls data will also be collected to see whether there is any association between footwear types and inpatient falls incidence.
The aim is to compare pillow paws (PPs) with sturdy outdoor footwear or sturdy slippers. In this way we hope to gain information on which footwear type is most beneficial to hospital inpatients. A recent similar study infers that sturdy outdoor footwear benefits outpatients, but it is not clear whether the same applies to a hospital inpatient population whom are often frailer with greater co-morbidities (physical and mental) and a higher falls risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor Shoes | Experimental | Other: Outdoor ShoesPatient will be asked to do balance tests while wearing outdoor shoes. |
| Pillow Paws Slippers | Active comparator | Other: Pillow Paw SlippersPatient will be asked to complete balance tests while wearing standard hospital issue 'Pillow Paw' slippers on their feet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Appropriate footwear
- Over 65 years
- Able to stand independently
- Inpatient in an acute geriatric assessment or rehabilitation ward
Key exclusion criteria (5 listed)
- Unable to stand independently
- Acutely unwell
- Terminally unwell
- Registered partially sighted or blind
- Using lower limb orthotic device
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 |
|---|---|---|
| Outdoor ShoesPatient will be wearing sturdy outdoor shoes to complete balance tests | Other | Outdoor Shoes |
| Pillow Paw SlippersPatient will be wearing Pillow Paws slippers to complete balance tests which are issued to patients who do not have shoes in NHS hospitals in the UK | Other | Pillow Paws Slippers |
Primary outcome
Functional Reach (centimeters)
Time frame: Day 1 (at time of single assessment)
Functional reach (FR):This is a measure of balance routinely performed on rehabilitation wards. The patient stands against a wall with one shoulder touching the wall and that arm fully extended horizontally. A mark is made on the wall recording the furthest point they are reaching to. They are then asked to stretch this arm as far forwards as they can without overbalancing/ stepping forwards. Another mark is made recording this maximum stretching distance. The difference between the 2 marks (in cm) is FR.
Timed Get-Up-And-Go (seconds)
Time frame: Day 1 (at time of single assessment)
Timed Get-Up-And-Go (TUG):- This is a measure of mobility that is recommended in guidelines for General Practitioners and hospital clinicians to perform as part of a simple falls risk assessment. The patient is timed on how long (IN SECONDS)it takes them to rise from a standard arm chair, walk to a line on the floor approx 10 feet away from chair, turn and return to the chair and sit back down.
The 4-point bedside balance score (0-4)
Time frame: Day 1 (at time of single assessment)
The 4-point bedside balance score:- This also assesses participants' balance. The patient's ability to stand with feet together, then with one foot slightly in front of the other (ie. standing partially heel to toe), followed by standing with one foot directly in front of the other (ie. standing fully heel to toe) and then standing on one leg is recorded. Increasing points are scored for each movement completed successfully. If it is clear that a patient cannot complete a particular movement, then the next level up in difficulty is not attempted.
Short Falls Efficiency Scale - International Questionnaire (score 7-28 points)
Time frame: Day 1 (at time of single assessment)
Short Falls Efficiency Scale - International (Short FES-I questionnaire) The patient will then be asked questions from the Short FES-I questionnaire. This asks the patient how concerned they would be about falling in the two footwear types in seven different situations. This is important to assess the influence footwear has on confidence.
1 secondary outcome
Incidence of falls during inpatient hospital stay
Time frame: Variable - duration of hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Background: PubMed 10423940Menz HB, Lord SR. Footwear and postural stability in older people. J Am Podiatr Med Assoc. 1999 Jul;89(7):346-57. doi: 10.7547/87507315-89-7-346.
- Background: PubMed 19001558Horgan NF, Crehan F, Bartlett E, Keogan F, O'Grady AM, Moore AR, Donegan CF, Curran M. The effects of usual footwear on balance amongst elderly women attending a day hospital. Age Ageing. 2009 Jan;38(1):62-7. doi: 10.1093/ageing/afn219. Epub 2008 Nov 11.
- Background: PubMed 8636591Lord SR, Bashford GM. Shoe characteristics and balance in older women. J Am Geriatr Soc. 1996 Apr;44(4):429-33. doi: 10.1111/j.1532-5415.1996.tb06416.x.
- Background: PubMed 17507530Jessup RL. Foot pathology and inappropriate footwear as risk factors for falls in a subacute aged-care hospital. J Am Podiatr Med Assoc. 2007 May-Jun;97(3):213-7. doi: 10.7547/0970213.
- Background: PubMed 12151688Burns SL, Leese GP, McMurdo ME. Older people and ill fitting shoes. Postgrad Med J. 2002 Jun;78(920):344-6. doi: 10.1136/pmj.78.920.344.
- Background: PubMed 15341555Fortinsky RH, Iannuzzi-Sucich M, Baker DI, Gottschalk M, King MB, Brown CJ, Tinetti ME. Fall-risk assessment and management in clinical practice: views from healthcare providers. J Am Geriatr Soc. 2004 Sep;52(9):1522-6. doi: 10.1111/j.1532-5415.2004.52416.x.
- Background: PubMed 18253023Menant JC, Steele JR, Menz HB, Munro BJ, Lord SR. Effects of footwear features on balance and stepping in older people. Gerontology. 2008;54(1):18-23. doi: 10.1159/000115850. Epub 2008 Feb 4.
- Background: PubMed 15507060Tencer AF, Koepsell TD, Wolf ME, Frankenfeld CL, Buchner DM, Kukull WA, LaCroix AZ, Larson EB, Tautvydas M. Biomechanical properties of shoes and risk of falls in older adults. J Am Geriatr Soc. 2004 Nov;52(11):1840-6. doi: 10.1111/j.1532-5415.2004.52507.x.
- Background: PubMed 16110238Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. doi: 10.1159/000086373.
- Background: PubMed 15341551Koepsell TD, Wolf ME, Buchner DM, Kukull WA, LaCroix AZ, Tencer AF, Frankenfeld CL, Tautvydas M, Larson EB. Footwear style and risk of falls in older adults. J Am Geriatr Soc. 2004 Sep;52(9):1495-501. doi: 10.1111/j.1532-5415.2004.52412.x.
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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.
Elizabeth Burleigh, MBChB MRCP study director
NHS Greater Glasgow and Clyde
Alison Craig, MBChB MRCP principal investigator
NHS Greater Glasgow and Clyde
Claire Steel, MBChB MRCP principal investigator
NHS Greater Glasgow and Clyde
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Shoes and Pillow Paw Slippers in people with Postural Balance and Accidental Falls, run by NHS Greater Glasgow and Clyde at 4 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 4 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: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Burleigh, MBChB MRCP (00441412016126, Liz.Burleigh@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Reach (centimeters) (time frame: Day 1 (at time of single assessment)). The study lists 4 primary outcomes in all. 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 NCT01132963, which also lists 10 linked publications.
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 28 May 2010.