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The Australian Navy Cerberus Orthotic Research (ANCOR) study: a randomised trial of foot orthoses for the prevention of overuse lower limb injuries in naval recruits

Comparison of the effectiveness of prefabricated foot orthoses versus flat insoles for the prevention of overuse lower limb injuries in naval recruits undertaking basic training

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000024549
Acronym
The ANCOR study: a randomised trial of foot orthoses for the prevention of overuse lower limb injuri
Enrollment
306
Registered
2015-01-16
Start date
2015-01-26
Completion date
2015-06-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Overuse lower limb injuries related to training are common in people who participate in regular physical activity. Foot orthoses are commonly used for the prevention of such injuries but evidence for their effectiveness is limited. In this study, participants will be randomised to using flat insoles or prefabricated foot orthosis while undertaking 11 weeks of basic training at the Royal Australian Navy Recruit School, Cerberus, Victoria, Australia. This randomised controlled trial will evaluate the effectiveness of foot orthoses for the prevention of lower limb injuries in naval recruits.

Interventions

The intervention group will receive a pair of Formthotics (Registered Trademark) prefabricated foot orthoses (Foot Science International, Christchurch, New Zealand). The insoles will be full-length insoles made from 140 kg/m3 single density, closed cell polyethylene foam. Each participant will have their foot orthoses fitted to their athletic shoes and Defence-issued boots (i.e. two pairs of insoles per participant). All participants will be asked to wear the foot orthoses as often as possible d

The intervention group will receive a pair of Formthotics (Registered Trademark) prefabricated foot orthoses (Foot Science International, Christchurch, New Zealand). The insoles will be full-length insoles made from 140 kg/m3 single density, closed cell polyethylene foam. Each participant will have their foot orthoses fitted to their athletic shoes and Defence-issued boots (i.e. two pairs of insoles per participant). All participants will be asked to wear the foot orthoses as often as possible during the 11 week trial. Adherence to the insoles will be documented by participants in weekly self-report diaries and navy medical records. In addition, adherence to the insoles will be confirmed with a blinded assessor at weeks 2 and 11.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All naval recruits undertaking 11 weeks of basic training at HMAS Cerberus will be invited to participate in the trial

Exclusion criteria

Participants will be excluded if they wear foot orthoses or have a lower limb injury (worst pain at least 30 mm on a 100 mm visual analogue scale) at the time of recruitment

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026