ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

falls

Condition category

Condition code

Injuries and Accidents

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]

Treatment: Devices

Intervention code [2]

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]

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]