Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001257752p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2022
Date registered
20/09/2022
Date last updated
20/09/2022
Date data sharing statement initially provided
20/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of balance-enhancing footwear on postural sway when standing and walking in older women
Scientific title
Effects of balance-enhancing footwear on postural sway when standing and walking in older women
Secondary ID [1] 307973 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 327640 0
Condition category
Condition code
Injuries and Accidents 324726 324726 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of the intervention and all testing procedures will be performed in the Foot and Ankle Laboratory at La Trobe University, Bundoora, Victoria, Australia.

The intervention is a pair of footwear and insoles designed to improve balance.

1. Footwear
The footwear incorporates features previously shown to be beneficial for balance. Specifically, it has a firm (Shore A hardness 55) rubber sole of 25 mm thickness under the heel and 18 mm under the forefoot, laces plus Velcro® fastening, a high collar to support the ankle, and a firm heel counter. The outersole has been modified to optimise slip resistance by grinding a 10 degree bevel into the heel region, placing grooves perpendicular to the sole (1.2 mm deep and 2.4 mm wide) across the heel surface area, and placing perpendicular grooves (5 mm deep and 12 mm wide) across the rest of the sole.

2. Insoles

The footwear incorporates a textured insole, constructed from 4 mm thick ethyl vinyl acetate (Shore A 25 ) with dome-shaped projections (3 mm high and 8 mm diameter, Shore A 85 ) placed across the forefoot in a 15 mm diamond pattern and along the lateral border, extending to the heel. The design of the textured insole was informed by previous studies reporting improvements on balance in older people when similar insoles were worn.

A research assistant with a podiatry degree and current registration will fit the footwear/insoles to each participant using a Brannock device.

The prototype footwear and the comparator condition (see next item) will be worn for a single assessment session. All participants will be tested in both footwear conditions, with the order of testing randomised.

The testing session will take a total of approximately 40 minutes, as described below:

1. Prototype footwear/insoles fitted and acclimatisation period (5 mins).
2. Sensor fitted. Standing balance tests (30 seconds each test - total approximately 5 mins).
3. Treadmill walking test (2 minutes continual walking).
4. Rest/wash-out period, sensor removed (10 mins).
5. Comparator footwear fitted and acclimatisation period (5 mins).
6. Sensor fitted. Standing balance tests (30 seconds each test - total approximately 5 mins).
7. Treadmill walking test (2 minutes continual walking).
Intervention code [1] 324431 0
Treatment: Devices
Intervention code [2] 324432 0
Prevention
Comparator / control treatment
The comparator will be flexible footwear (Dunlop Volley™, Pacific Brands, Australia) which has a rubber sole of uniform 18 mm thickness, a hardness of Shore A 35 , and lace fixation. The flexible footwear has no features considered to be either beneficial or detrimental to balance.
Control group
Active

Outcomes
Primary outcome [1] 332552 0
Dynamic postural sway (mm): while walking on a treadmill at their comfortable self-selected speed, participants will wear a Gyko sensor attached to their upper back (in the region of the thoracic spine). The sensor will record upper trunk accelerations as a measure of dynamic stability.
Timepoint [1] 332552 0
Measured continuously for 2 minutes.
Secondary outcome [1] 413884 0
Walking speed (metres/second): while walking on a treadmill at their comfortable self-selected speed, the participant's walking speed will be measured using the OptoGait system. This system consists of two bars that are placed either side of a treadmill. Each bar contains 96 LEDs, and the system detects the interruptions of the communication between the bars caused by the participant’s movement.
Timepoint [1] 413884 0
Measured continuously for 2 minutes.
Secondary outcome [2] 413885 0
Cadence (steps/minute): while walking on a treadmill at their comfortable self-selected speed, the participant's cadence will be measured using the OptoGait system. This system consists of two bars that are placed either side of a treadmill. Each bar contains 96 LEDs, and the system detects the interruptions of the communication between the bars caused by the participant’s movement.
Timepoint [2] 413885 0
Measured continuously for 2 minutes.
Secondary outcome [3] 413886 0
Step length (cm): while walking on a treadmill at their comfortable self-selected speed, the participant's cadence will be measured using the OptoGait system. This system consists of two bars that are placed either side of a treadmill. Each bar contains 96 LEDs, and the system detects the interruptions of the communication between the bars caused by the participant’s movement.
Timepoint [3] 413886 0
Measured continuously for 2 minutes.
Secondary outcome [4] 413887 0
Standing postural sway (mm): while standing in a relaxed bipedal position, participants will wear a Gyko sensor attached to their upper back (in the region of the thoracic spine). The sensor will record upper trunk accelerations as a measure of postural sway. Testing will be performed with eyes open and closed, while standing on the floor and a foam rubber mat, and with feet in a tandem position (one foot in front of the other).
Timepoint [4] 413887 0
Measured continuously for 30 seconds for each condition (i.e. eyes open and closed, while standing on the floor and a foam rubber mat, and in tandem position).

Eligibility
Key inclusion criteria
Inclusion criteria: female, aged 65 years and over, independently community-dwelling, able to walk household distances without a walking aid, able to understand English in written and verbal form.
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: neurodegenerative conditions (eg: Parkinson’s disease), lower limb amputation, foot and ankle surgery in previous 3 months. These exclusion criteria are important to ensure that participants are not frail and are able to undertake the balance and gait tests safely and comfortably.

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)
Allocation is not concealed
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
Repeated measures experiment
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences in gait and balance test performance between the two footwear conditions (flexible footwear and prototype footwear) will be evaluated using t-tests. Effect sizes for comparisons will be calculated using Cohen’s d, and will be interpreted as follows: less than or equal to 0.01 = very small, >0.01 to 0.20 = small, >0.20 to 0.50 = medium, >0.50 to 0.8 = large, >0.80 = very large,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38529 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 312242 0
Government body
Name [1] 312242 0
National Health and Medical Research Council of Australia
Country [1] 312242 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd and Kingsbury Drive
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 313785 0
None
Name [1] 313785 0
Address [1] 313785 0
Country [1] 313785 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311618 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 311618 0
Ethics committee country [1] 311618 0
Australia
Date submitted for ethics approval [1] 311618 0
30/08/2022
Approval date [1] 311618 0
Ethics approval number [1] 311618 0

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

Contacts
Principal investigator
Name 121738 0
Prof Hylton B Menz
Address 121738 0
Discipline of Podiatry
School of Allied Health, Human Services and Sport
Kingsbury Drive
La Trobe University, Bundoora
Victoria 3086 Australia
Country 121738 0
Australia
Phone 121738 0
+61 0394795801
Fax 121738 0
Email 121738 0
[email protected]
Contact person for public queries
Name 121739 0
Hylton B Menz
Address 121739 0
Discipline of Podiatry
School of Allied Health, Human Services and Sport
Kingsbury Drive
La Trobe University, Bundoora
Victoria 3086 Australia
Country 121739 0
Australia
Phone 121739 0
+61 0394795801
Fax 121739 0
Email 121739 0
[email protected]
Contact person for scientific queries
Name 121740 0
Hylton B Menz
Address 121740 0
Discipline of Podiatry
School of Allied Health, Human Services and Sport
Kingsbury Drive
La Trobe University, Bundoora
Victoria 3086 Australia
Country 121740 0
Australia
Phone 121740 0
+61 0394795801
Fax 121740 0
Email 121740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Contact chief investigator by email ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



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.