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Trial registered on ANZCTR
Registration number
ACTRN12624001496505
Ethics application status
Approved
Date submitted
9/12/2024
Date registered
20/12/2024
Date last updated
6/07/2025
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Acceptability of balance-enhancing outdoor shoes compared to minimalist outdoor shoes in older women: a randomised crossover trial
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Scientific title
Acceptability of balance-enhancing outdoor shoes compared to minimalist outdoor shoes in older women: a randomised crossover trial
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Secondary ID [1]
313463
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None
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Universal Trial Number (UTN)
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Trial acronym
BALANCE-OUT: BALAnce eNhanCing shoEs for oldeR women: OUTdoor
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Falls
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Aging
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Balance impairment
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Condition category
Condition code
Physical Medicine / Rehabilitation
332450
332450
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a crossover trial where participants will receive each intervention. The initial appointment and subsequent appointments will be 2 hours in duration.
There is no wash-out period between treatments.
Balance-enhancing outdoor shoes:
The balance-enhancing outdoor shoes include features to improve balance performance such as: (i) increased collar height, (ii) adequate fixation and (iii) textured insoles. Participants will be provided appropriately sized balance-enhancing outdoor shoes (Balla Balance Leather Lace Up Boots™) by a registered podiatrist during an appointment in the Podiatry Clinic Research Room at La Trobe University, Melbourne (Bundoora) campus.
Participants will be asked to wear the provided balance-enhancing outdoor shoes as much as possible when outdoors for a six-week period.
Adherence will be measured by an orthotimer® sensor. These sensors will be embedded into the sockliner of the balance-enhancing outdoor shoes prior to participants receiving them. The orthotimer® sensors are small enough that when placed strategically into the shoes sockliner, they will be imperceptible.
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Intervention code [1]
330036
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Treatment: Other
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Comparator / control treatment
This is a crossover trial where participants will receive each intervention. The initial appointment and subsequent appointments will be 2 hours in duration.
There is no wash-out period between treatments.
Minimalist outdoor shoes:
Participants will be provided appropriately sized minimalist outdoor shoes (Basic Lace Up Canvas Shoes™) by a registered podiatrist during an appointment in the Podiatry Clinic Research Room at La Trobe University, Melbourne (Bundoora) campus. The minimalist outdoor shoes incorporate features such as high flexibility, low heel to toe drop, low weight and low stack height. This shoe aligns with the consensus definition of Esculier et al., 2015 (https://doi.org/10.1186/s13047-015-0094-5).
Participants will be asked to wear the provided minimalist outdoor shoes as much as possible when outdoors for a six-week period.
Adherence will be measured by an orthotimer® sensor. These sensors will be embedded into the sockliner of the balance-enhancing outdoor shoes prior to participants receiving them. The orthotimer® sensors are small enough that when placed strategically into the shoes sockliner, they will be imperceptible.
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Control group
Active
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Outcomes
Primary outcome [1]
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Footwear acceptability
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Assessment method [1]
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Monitor Orthopedic Shoes Questionnaire (MOSQ)
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Timepoint [1]
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Participants will wear each pair of shoes for six weeks and the primary time point will be at six weeks. They will be required to attend at baseline, six weeks and 12 weeks. Baseline, six weeks and 12 weeks
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Secondary outcome [1]
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Balance performance
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Assessment method [1]
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Postural sway testing via validated GyKo® system
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Timepoint [1]
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Participants will wear each pair of shoes for six weeks. They will be required to attend at baseline, six weeks and 12 weeks.
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Secondary outcome [2]
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Perceived risk of falling
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Assessment method [2]
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Falls Efficacy Scale International (FES-I)
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Timepoint [2]
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Participants will wear each pair of shoes for six weeks. They will be required to attend at baseline, six weeks and 12 weeks.
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Eligibility
Key inclusion criteria
- Identify as a woman
- Aged 65 years or older
- Able to walk household distances (more than 50 metres) without the use of a walking aid
- Free of any disease or condition which interferes with balance or walking (e.g. Parkinson's disease)
- Free of any surgery to the foot or ankle in the past 12 months
- Located in metropolitan Melbourne
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Have a current or history of plantar ulcer
- Have a major foot deformity (e.g. Chorcot foot)
- Amputation of the lower extremity including minor amputation
- Shoe sizes smaller than a size 5 (AU) or greater than size 11 (AU)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
24/02/2025
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Date of last participant enrolment
Anticipated
5/09/2025
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Actual
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Date of last data collection
Anticipated
19/12/2025
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Actual
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Sample size
Target
44
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Accrual to date
42
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
43456
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3086 - La Trobe University
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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La Trobe University
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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ecnalabs, pty, ltd
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Address [2]
317900
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Country [2]
317900
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
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Country
Australia
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Secondary sponsor category [1]
320243
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Commercial sector/Industry
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Name [1]
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ecnalabs, pty, ltd
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Address [1]
320243
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Country [1]
320243
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
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https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316588
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01/11/2024
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Approval date [1]
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15/01/2025
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Ethics approval number [1]
316588
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HEC24476
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Summary
Brief summary
The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing outdoor shoes more acceptable than the minimalist outdoor shoes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Hylton Menz
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Address
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La Trobe University Plenty Rd, Bundoora Victoria 3086
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Country
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Australia
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Phone
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+61 03 9479 5801
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ameer Nor Azhar
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Address
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La Trobe University Plenty Rd, Bundoora Victoria 3086
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Country
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Australia
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Phone
138335
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+61 03 94793310
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Fax
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Email
138335
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[email protected]
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Contact person for scientific queries
Name
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Ameer Nor Azhar
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Address
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La Trobe University Plenty Rd, Bundoora Victoria 3086
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Country
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Australia
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Phone
138336
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+61 03 94793310
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Fax
138336
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Email
138336
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Interested researchers upon reasonable request.
Conditions for requesting access:
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-
What individual participant data might be shared?
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All de-identified individual line-by-line data
What types of analyses could be done with individual participant data?
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Only to achieve the aims in the approved proposal.
When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
•
Contact the principal investigator via email at
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
PICF_v3.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF