The Effects of Footwear on Balance and Confidence in Older Inpatients

NCT01132963 | Unknown

• 1 other identifier: GN09GE487
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Postural Balance; Accidental Falls

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (1)

• Incidence of falls during inpatient hospital stay

  Variable - duration of hospital admission

Study Arms (2)

Outdoor Shoes

EXPERIMENTAL

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

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

Other: Pillow Paw Slippers

Interventions

Outdoor Shoes OTHER

Patient will be wearing sturdy outdoor shoes to complete balance tests

Outdoor Shoes

Pillow Paw Slippers 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

Pillow Paws Slippers

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to stand independently
• Acutely unwell
• Terminally unwell
• Registered partially sighted or blind
• Using lower limb orthotic device

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (4)

Stobhill Hospital

Glasgow, Lanarkshire, G21 3UW, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, Lanarkshire, G4 0SF, United Kingdom

Location

Mansionhouse Unit, Victoria Infirmary

Glasgow, Lanarkshire, G41 3DX, United Kingdom

Location

Southern General Hospital

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 10423940 BACKGROUND

• 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.

  PMID: 19001558 BACKGROUND

• 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.

  PMID: 8636591 BACKGROUND

• 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.

  PMID: 17507530 BACKGROUND

• 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.

  PMID: 12151688 BACKGROUND

• 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.

  PMID: 15341555 BACKGROUND

• 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.

  PMID: 18253023 BACKGROUND

• 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.

  PMID: 15507060 BACKGROUND

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

  PMID: 16110238 BACKGROUND

• 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.

  PMID: 15341551 BACKGROUND

Study Officials

• Elizabeth Burleigh, MBChB MRCP

  NHS Greater Glasgow and Clyde

  STUDY DIRECTOR

• Alison Craig, MBChB MRCP

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Claire Steel, MBChB MRCP

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Jennifer Tilston, MBChB MRCP

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Lynsey Fielden, MBChB MRCP

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Steven Wishart, MBChB MRCP

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Burleigh, MBChB MRCP

CONTACT

00441412016126; Liz.Burleigh@ggc.scot.nhs.uk

Alison J Craig, MBChB MRCP

CONTACT

00441413391968; alisoncraig2@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 28, 2010

Record last verified: 2010-03

Locations

GB (4)