The Effects of Footwear on Balance and Confidence in Older Inpatients

May 27, 2010 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G21 3UW
        • Stobhill Hospital
      • Glasgow, Lanarkshire, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary
      • Glasgow, Lanarkshire, United Kingdom, G41 3DX
        • Mansionhouse Unit, Victoria Infirmary
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • Southern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (at time of single assessment)
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.
Day 1 (at time of single assessment)
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.
Day 1 (at time of single assessment)
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.
Day 1 (at time of single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Variable - duration of hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • GN09GE487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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