Trial Review

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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
Scientific title
Acceptability of balance-enhancing outdoor shoes compared to minimalist outdoor shoes in older women: a randomised crossover trial
Secondary ID [1] 313463 0
None
Universal Trial Number (UTN)
Trial acronym
BALANCE-OUT: BALAnce eNhanCing shoEs for oldeR women: OUTdoor
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 335867 0
Aging 335865 0
Balance impairment 335866 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332450 332450 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330036 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339990 0
Footwear acceptability
Timepoint [1] 339990 0
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
Secondary outcome [1] 442242 0
Balance performance
Timepoint [1] 442242 0
Participants will wear each pair of shoes for six weeks. They will be required to attend at baseline, six weeks and 12 weeks.
Secondary outcome [2] 442241 0
Perceived risk of falling
Timepoint [2] 442241 0
Participants will wear each pair of shoes for six weeks. They will be required to attend at baseline, six weeks and 12 weeks.

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
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
24/02/2025
Date of last participant enrolment
Anticipated
5/09/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
44
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43456 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 317899 0
University
Name [1] 317899 0
La Trobe University
Country [1] 317899 0
Australia
Funding source category [2] 317900 0
Commercial sector/Industry
Name [2] 317900 0
ecnalabs, pty, ltd
Country [2] 317900 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 320243 0
Commercial sector/Industry
Name [1] 320243 0
ecnalabs, pty, ltd
Address [1] 320243 0
Country [1] 320243 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316588 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 316588 0
Ethics committee country [1] 316588 0
Australia
Date submitted for ethics approval [1] 316588 0
01/11/2024
Approval date [1] 316588 0
15/01/2025
Ethics approval number [1] 316588 0
HEC24476

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138334 0
Prof Hylton Menz
Address 138334 0
La Trobe University Plenty Rd, Bundoora Victoria 3086
Country 138334 0
Australia
Phone 138334 0
+61 03 9479 5801
Fax 138334 0
Email 138334 0
[email protected]
Contact person for public queries
Name 138335 0
Ameer Nor Azhar
Address 138335 0
La Trobe University Plenty Rd, Bundoora Victoria 3086
Country 138335 0
Australia
Phone 138335 0
+61 03 94793310
Fax 138335 0
Email 138335 0
[email protected]
Contact person for scientific queries
Name 138336 0
Ameer Nor Azhar
Address 138336 0
La Trobe University Plenty Rd, Bundoora Victoria 3086
Country 138336 0
Australia
Phone 138336 0
+61 03 94793310
Fax 138336 0
Email 138336 0
[email protected]

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:
• Interested researchers upon reasonable request.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified individual line-by-line data

What types of analyses could be done with individual participant data?
• 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:
-

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?

TypeCitationLinkEmailOther DetailsAttachment
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.