The Effects of Footwear on Balance and Confidence in Older Inpatients

Accidental Falls Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01132963
• Other study ID #: GN09GE487
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2010
• Last updated: May 27, 2010
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2010
• Source: NHS Greater Glasgow and Clyde
• Contact: Elizabeth Burleigh, MBChB MRCP
• Phone: 00441412016126
• Email: Liz.Burleigh[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee (now called National Research Ethics Service)United Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls
• Postural Balance

Intervention

Other:
• Outdoor Shoes
Patient will be wearing sturdy outdoor shoes to complete balance tests
• 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

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow	Lanarkshire
United Kingdom	Mansionhouse Unit, Victoria Infirmary	Glasgow	Lanarkshire
United Kingdom	Southern General Hospital	Glasgow	Lanarkshire
United Kingdom	Stobhill Hospital	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Burns SL, Leese GP, McMurdo ME. Older people and ill fitting shoes. Postgrad Med J. 2002 Jun;78(920):344-6. — View 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. — View 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. — View 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. — View 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. — View Citation

Lord SR, Bashford GM. Shoe characteristics and balance in older women. J Am Geriatr Soc. 1996 Apr;44(4):429-33. — View 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. — View Citation

Menz HB, Lord SR. Footwear and postural stability in older people. J Am Podiatr Med Assoc. 1999 Jul;89(7):346-57. Review. — View Citation

Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (at time of single assessment)	No
Primary	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.	Day 1 (at time of single assessment)	No
Primary	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.	Day 1 (at time of single assessment)	No
Primary	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.	Day 1 (at time of single assessment)	No
Secondary	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.	Variable - duration of hospital admission	Yes