La Trobe
27804_Bonanno,D_2015.pdf (891.49 kB)

Foot orthoses for the prevention of lower limb overuse injuries in naval recruits: study protocol for a randomised controlled trial

Download (891.49 kB)
Background: Foot orthoses are frequently used for the prevention of lower limb overuse injuries but evidence for their effectiveness is limited. The primary aim of this study is to determine if prefabricated foot orthoses reduce the incidence of lower limb overuse injuries in naval recruits undertaking 11weeks of basic training. Methods: This study is a participant and assessor blinded, parallel-group, randomised controlled trial. The trial will recruit participants undertaking 11weeks of basic training at the Royal Australian Navy Recruit School, Cerberus, Victoria, Australia. Participants will be randomised to a control group (flat insole) or an intervention group (prefabricated foot orthosis). Over the 11weeks of basic training, participants will document the presence and location of pain in weekly self-report diaries. The end-point for each participant will be the completion of 11weeks of basic training. The primary outcome measure will be the combined incidence of four lower limb injuries (medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy, and plantar fasciitis/plantar heel pain) which are common among defence members. Secondary outcome measures include: (i) overall incidence of lower limb pain, (ii) severity of lower limb pain, (iii) time to injury, (iv) time to drop-out due to injury, (v) adverse events, (vi) number of lost training days, (vii) shoe comfort, and (viii) general health status. Data will be analysed using the intention-to-treat principle. Discussion: This randomised controlled trial will evaluate the effectiveness of prefabricated foot orthoses for the prevention of common lower limb overuse injuries in naval recruits. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12615000024549 .


This study is funded by the La Trobe University Sport, Exercise and Rehabilitation Research Focus Area. The foot orthoses and flat insoles will be donated by Foot Science International Ltd, Christchurch, New Zealand. Foot Science International were not involved in the design of the trial, and will not be involved in the conduct, data analysis and interpretation of the findings of the trial. HBM is currently a National Health and Medical Research Council fellow (Clinical Career Development Award, ID: 433049). We would like to thank the Royal Australian Navy Recruit School, Cerberus, Victoria, Australia for agreeing to collaborate on this project and their ongoing support.


Publication Date



Journal of Foot and Ankle Research





Article Number





BioMed Central



Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.

Usage metrics

    Journal Articles


    No categories selected



    Ref. manager