Clinical trial NCT01132963: The Effects of Footwear on Balance and Confidence in Older Inpatients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postural Balance
Accidental Falls
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Reach (centimeters)
timeFrame: Day 1 (at time of single assessment)
measure: Timed Get-Up-And-Go (seconds)
timeFrame: Day 1 (at time of single assessment)
measure: The 4-point bedside balance score (0-4)
timeFrame: Day 1 (at time of single assessment)
measure: Short Falls Efficiency Scale - International Questionnaire (score 7-28 points)
timeFrame: Day 1 (at time of single assessment)
Secondary outcomes:
measure: Incidence of falls during inpatient hospital stay
timeFrame: Variable - duration of hospital admission
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Stobhill Hospital
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Mansionhouse Unit, Victoria Infirmary
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
state: Lanarkshire
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Elizabeth Burleigh, MBChB MRCP
role: STUDY_DIRECTOR
affiliation: NHS Greater Glasgow and Clyde
name: Alison Craig, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Claire Steel, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Jennifer Tilston, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Lynsey Fielden, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Steven Wishart, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. doi: 10.1159/000086373.
citation: 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.