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Trial registered on ANZCTR


Registration number
ACTRN12617001128381
Ethics application status
Approved
Date submitted
27/07/2017
Date registered
1/08/2017
Date last updated
1/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Footwear and insoles to improve balance and gait in older people
Scientific title
Preliminary evaluation of prototype footwear and insoles to optimise balance and gait in older women
Secondary ID [1] 292545 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 304200 0
Condition category
Condition code
Injuries and Accidents 303537 303537 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a pair of footwear and insoles designed to improve balance.

1. Footwear
The prototype footwear is based on an existing model (Dr Comfort® Vigor, Mequon, WI, USA) which was selected as it incorporates many of the features previously shown to be beneficial for balance. Specifically, the footwear had 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. Across the size range, the weight of the prototype footwear is 310 to 360 gm. 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.

The prototype footwear with the insoles inserted will be worn for a single assessment session. Testing for each of the footwear conditions will take approximately 30 minutes. In between each footwear condition, there will be a brief 10 min washout period.
Intervention code [1] 298742 0
Treatment: Devices
Intervention code [2] 298755 0
Prevention
Comparator / control treatment
1. Participant's own footwear
For the ‘own footwear’ condition, participants will be asked to bring to the testing session the footwear they wear most often when outdoors.

2. Flexible footwear (Dunlop Volleys)
The flexible footwear (Dunlop Volley™, Pacific Brands, Australia) has a rubber sole of uniform 18 mm thickness, a hardness of Shore A 35 , and lace fixation. Across the size range, the weight of the flexible footwear is 280 to 420 gm. The flexible footwear was selected as a control condition as it has no features considered to be either beneficial or detrimental to balance.
Control group
Active

Outcomes
Primary outcome [1] 302906 0
Postural sway
Using the Neurocom Balance Master system, postural sway will be measured in °/sec from three trials of 20 sec duration while standing on a foam rubber mat (46 cm wide x 46 long x 13 cm thick).
Timepoint [1] 302906 0
Immediate effect (repeated measures experiment)
Primary outcome [2] 302922 0
Limits of stability
Using the Neurocom Balance Master system, the limits of stability test, which quantifies the maximum distance the participant can intentionally displace and maintain the stability of their centre of gravity, will be performed with participants leaning in eight directions at 45 degree intervals represented by targets on a computer monitor. Participants will be instructed to keep their feet on the ground and use their body to lean towards each target. Maximum excursion (expressed as a percentage of each participant’s limits of stability, determined by their height) and directional control (expressed as a percentage, with 100% representing a straight line from the centre of pressure to the target) will be averaged across the eight directions.
Timepoint [2] 302922 0
Immediate effect (repeated measures experiment)
Primary outcome [3] 302923 0
Tandem stance test
Using the Neurocom Balance Master system, the tandem walk test will require participants to walk heel to toe from one end of the force plate to the other three times. After reaching the end of the platform, participants will be instructed to maintain their tandem stance position for five seconds while their sway is recorded. Measured parameters during this test are speed (cm/sec) and step width (cm) while traversing the platform, and endpoint sway velocity (°/sec) at completion of the task.
Timepoint [3] 302923 0
Immediate effect (repeated measures experiment)
Secondary outcome [1] 337400 0
Velocity
Using the GAITRite walkway, participants will be asked to walk at their normal comfortable speed, and an average of three trials of each footwear condition were documented. Velocity is measured as the metres per second.
Timepoint [1] 337400 0
Immediate effect (repeated measures experiment)
Secondary outcome [2] 337438 0
Cadence
Using the GAITRite walkway, participants will be asked to walk at their normal comfortable speed, and an average of three trials of each footwear condition were documented. Cadence is measured as the number of steps per minute.
Timepoint [2] 337438 0
Immediate effect (repeated measures experiment)
Secondary outcome [3] 337439 0
Step length
Using the GAITRite walkway, participants will be asked to walk at their normal comfortable speed, and an average of three trials of each footwear condition were documented. Step length is measured in cm.
Timepoint [3] 337439 0
Immediate effect (repeated measures experiment)
Secondary outcome [4] 337440 0
Step width
Using the GAITRite walkway, participants will be asked to walk at their normal comfortable speed, and an average of three trials of each footwear condition were documented. Step width is measured in cm.
Timepoint [4] 337440 0
Immediate effect (repeated measures experiment)

Eligibility
Key inclusion criteria
1. Female
2. Aged 65 years and over
3. Living independently in the community
4. Able to walk household distances without a walking aid
5. 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
1. Cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire)
2. Neurodegenerative condition such as Parkinson’s disease
3. Lower limb amputation
4. Foot and ankle surgery in previous three months

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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)
Not applicable
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 between the three footwear conditions (flexible footwear, participants’ own footwear, and prototype footwear) will be evaluated using repeated measures analysis of variance (ANOVA) with Bonferroni-adjusted post-hoc tests for pairwise comparisons. The effect sizes for all significant main effects will be calculated using the eta-squared statistic and will be interpreted using the following cut-offs: 0 to 0.06 (small), >0.06 to 0.14 (medium) and >0.14 (large) .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/09/2015
Date of last participant enrolment
Anticipated
Actual
25/07/2016
Date of last data collection
Anticipated
Actual
25/07/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297117 0
University
Name [1] 297117 0
La Trobe University
Country [1] 297117 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] 296133 0
None
Name [1] 296133 0
Address [1] 296133 0
Country [1] 296133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298295 0
La Trobe University Faculty of Health Sciences Human Ethics Committee
Ethics committee address [1] 298295 0
Plenty Rd and Kingsbury Dr
Bundoora
Victoria 3086
Ethics committee country [1] 298295 0
Australia
Date submitted for ethics approval [1] 298295 0
12/11/2014
Approval date [1] 298295 0
16/06/2015
Ethics approval number [1] 298295 0
FHEC14/254

Summary
Brief summary
Footwear has the potential to influence balance in either a detrimental or beneficial manner, and is therefore an important consideration in relation to falls prevention. The objective of this study was to evaluate balance ability and gait patterns in older women while wearing prototype footwear and insoles designed to improve balance.
Trial website
None
Trial related presentations / publications
Menz HB, Auhl M, Munteanu SE. Effects of indoor footwear on balance and gait patterns in community-dwelling older women. Gerontology. 2017;63:129-136.
Public notes

Contacts
Principal investigator
Name 76622 0
Prof Hylton B Menz
Address 76622 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health
College of Science, Health and Engineering
Kingsbury Drive
La Trobe University
Bundoora, Victoria 3086
Country 76622 0
Australia
Phone 76622 0
+61394795801
Fax 76622 0
+61394795415
Email 76622 0
[email protected]
Contact person for public queries
Name 76623 0
Hylton B Menz
Address 76623 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health
College of Science, Health and Engineering
Kingsbury Drive
La Trobe University
Bundoora, Victoria 3086
Country 76623 0
Australia
Phone 76623 0
+61394865274
Fax 76623 0
+61394795415
Email 76623 0
[email protected]
Contact person for scientific queries
Name 76624 0
Hylton B Menz
Address 76624 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health
College of Science, Health and Engineering
Kingsbury Drive
La Trobe University
Bundoora, Victoria 3086
Country 76624 0
Australia
Phone 76624 0
+61394865274
Fax 76624 0
+61394795415
Email 76624 0
[email protected]

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