The Effects of Footwear on Balance and Confidence in Older Inpatients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomised Crossover Study to Evaluate the Effect Different Footwear Type Has on Measures of Balance and Confidence in Older Hospital Inpatients

Conditions
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Postural Balance, Accidental Falls

Intervention / Treatment
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* Other: Outdoor Shoes
* Other: Pillow Paw Slippers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outdoor Shoes<br>Patient will be asked to do balance tests while wearing outdoor shoes. | Other: Outdoor Shoes<br>* Patient will be wearing sturdy outdoor shoes to complete balance tests<br>|
| Active Comparator: Pillow Paws Slippers<br>Patient will be asked to complete balance tests while wearing standard hospital issue 'Pillow Paw' slippers on their feet | Other: Pillow Paw Slippers<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |