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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde |
United Kingdom,
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
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 |
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