The Effects of Footwear on Balance and Confidence in Older Inpatients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by NHS Greater Glasgow and Clyde.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01132963
First received: May 27, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Postural Balance
Accidental Falls
Other: Outdoor Shoes
Other: Pillow Paw Slippers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Functional Reach (centimeters) [ Time Frame: Day 1 (at time of single assessment) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of falls during inpatient hospital stay [ Time Frame: Variable - duration of hospital admission ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132963

Contacts
Contact: Elizabeth Burleigh, MBChB MRCP 00441412016126 Liz.Burleigh@ggc.scot.nhs.uk
Contact: Alison J Craig, MBChB MRCP 00441413391968 alisoncraig2@nhs.net

Locations
United Kingdom
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         
Stobhill Hospital Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G21 3UW
Principal Investigator: Claire Steel, MBChB MRCP         
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Dr Elizabeth Burleigh, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01132963     History of Changes
Other Study ID Numbers: GN09GE487
Study First Received: May 27, 2010
Last Updated: May 27, 2010
Health Authority: United Kingdom: Research Ethics Committee (now called National Research Ethics Service)
United Kingdom: National Health Service

ClinicalTrials.gov processed this record on September 22, 2014