The Effects of Footwear on Balance and Confidence in Older Inpatients
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|ClinicalTrials.gov Identifier: NCT01132963|
Recruitment Status : Unknown
Verified March 2010 by NHS Greater Glasgow and Clyde.
Recruitment status was: Not yet recruiting
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Postural Balance Accidental Falls||Other: Outdoor Shoes Other: Pillow Paw Slippers||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2010|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||November 2010|
Experimental: Outdoor Shoes
Patient will be asked to do balance tests while wearing outdoor shoes.
Other: Outdoor Shoes
Patient will be wearing sturdy outdoor shoes to complete balance tests
Active Comparator: Pillow Paws Slippers
Patient will be asked to complete balance tests while wearing standard hospital issue 'Pillow Paw' slippers on their feet
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
- Functional Reach (centimeters) [ Time Frame: Day 1 (at time of single assessment) ]
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.
- Timed Get-Up-And-Go (seconds) [ Time Frame: Day 1 (at time of single assessment) ]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.
- The 4-point bedside balance score (0-4) [ Time Frame: Day 1 (at time of single assessment) ]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.
- Short Falls Efficiency Scale - International Questionnaire (score 7-28 points) [ Time Frame: Day 1 (at time of single assessment) ]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.
- Incidence of falls during inpatient hospital stay [ Time Frame: Variable - duration of hospital admission ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132963
|Contact: Elizabeth Burleigh, MBChB MRCP||00441412016126||Liz.Burleigh@ggc.scot.nhs.uk|
|Contact: Alison J Craig, MBChB MRCPemail@example.com|
|Stobhill Hospital||Not yet recruiting|
|Glasgow, Lanarkshire, United Kingdom, G21 3UW|
|Principal Investigator: Claire Steel, MBChB MRCP|
|Glasgow Royal Infirmary||Not yet recruiting|
|Glasgow, Lanarkshire, United Kingdom, G4 0SF|
|Principal Investigator: Alison Craig, MBChB MRCP|
|Mansionhouse Unit, Victoria Infirmary||Not yet recruiting|
|Glasgow, Lanarkshire, United Kingdom, G41 3DX|
|Principal Investigator: Jennifer Tilston, MBChB MRCP|
|Southern General Hospital||Not yet recruiting|
|Glasgow, Lanarkshire, United Kingdom, G51 4TF|
|Principal Investigator: Steven Wishart, MBChB MRCP|
|Study Director:||Elizabeth Burleigh, MBChB MRCP||NHS Greater Glasgow and Clyde|
|Principal Investigator:||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|