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Open Access Study protocol

EXACT: EXercise or Advice after ankle fraCTure. Design of a randomised controlled trial

Paula R Beckenkamp1, C Christine Lin1, Robert D Herbert1, Marion Haas2, Kriti Khera1, Anne M Moseley1* and the EXACT Team

Author Affiliations

1 The George Institute for Global Health, Sydney Medical School, The University of Sydney, PO Box M201, Missenden Road Sydney, New South Wales 2000, Australia

2 Centre for Health Economics Research and Evaluation (CHERE), University of Technology, Sydney, PO Box 123, Broadway, New South Wales 2007, Australia

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BMC Musculoskeletal Disorders 2011, 12:148  doi:10.1186/1471-2474-12-148

Published: 5 July 2011

Abstract

Background

Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone.

Methods/Design

A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an Advice or Rehabilitation group. Participants in the Advice group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the Rehabilitation group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years.

Discussion

This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.