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The Effects of Footwear on Balance and Confidence in Older Inpatients

NCT ID: NCT01132963

Last Updated: 2010-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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

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Postural Balance Accidental Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Outdoor Shoes

Patient will be asked to do balance tests while wearing outdoor shoes.

Group Type EXPERIMENTAL

Outdoor Shoes

Intervention Type OTHER

Patient will be wearing sturdy outdoor shoes to complete balance tests

Pillow Paws Slippers

Patient will be asked to complete balance tests while wearing standard hospital issue 'Pillow Paw' slippers on their feet

Group Type ACTIVE_COMPARATOR

Pillow Paw Slippers

Intervention Type OTHER

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

Interventions

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Outdoor Shoes

Patient will be wearing sturdy outdoor shoes to complete balance tests

Intervention Type OTHER

Pillow Paw Slippers

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Appropriate footwear
* Over 65 years
* Able to stand independently
* Inpatient in an acute geriatric assessment or rehabilitation ward

Exclusion Criteria

* Unable to stand independently
* Acutely unwell
* Terminally unwell
* Registered partially sighted or blind
* Using lower limb orthotic device
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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NHS Greater Glasgow and Clyde

Principal Investigators

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Elizabeth Burleigh, MBChB MRCP

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

Alison Craig, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Claire Steel, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Jennifer Tilston, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Lynsey Fielden, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Steven Wishart, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

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Stobhill Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status

Glasgow Royal Infirmary

Glasgow, Lanarkshire, United Kingdom

Site Status

Mansionhouse Unit, Victoria Infirmary

Glasgow, Lanarkshire, United Kingdom

Site Status

Southern General Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Elizabeth Burleigh, MBChB MRCP

Role: CONTACT

Phone: 00441412016126

Email: [email protected]

Alison J Craig, MBChB MRCP

Role: CONTACT

Phone: 00441413391968

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 10423940 (View on PubMed)

Horgan 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.

Reference Type BACKGROUND
PMID: 19001558 (View on PubMed)

Lord 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.

Reference Type BACKGROUND
PMID: 8636591 (View on PubMed)

Jessup 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.

Reference Type BACKGROUND
PMID: 17507530 (View on PubMed)

Burns 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.

Reference Type BACKGROUND
PMID: 12151688 (View on PubMed)

Fortinsky 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.

Reference Type BACKGROUND
PMID: 15341555 (View on PubMed)

Menant 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.

Reference Type BACKGROUND
PMID: 18253023 (View on PubMed)

Tencer 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.

Reference Type BACKGROUND
PMID: 15507060 (View on PubMed)

Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. doi: 10.1159/000086373.

Reference Type BACKGROUND
PMID: 16110238 (View on PubMed)

Koepsell 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.

Reference Type BACKGROUND
PMID: 15341551 (View on PubMed)

Other Identifiers

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GN09GE487

Identifier Type: -

Identifier Source: org_study_id