Abstract:
Background: Passive joint mobilisation is a technique frequently used by physiotherapists to
reduce pain, improve joint movement and facilitate a return to activities after injury, but its use after
ankle fracture is currently based on limited evidence. The primary aim of this trial is to determine
if adding joint mobilisation to a standard exercise programme is effective and cost-effective after
cast immobilisation for ankle fracture in adults.
Methods/Design: Ninety participants will be recruited from the physiotherapy departments of
three teaching hospitals and randomly allocated to treatment or control groups using a concealed
procedure. All participants will perform an exercise programme. Participants in the treatment
group will also receive joint mobilisation twice a week for four weeks. Blinded follow-up
assessments will be conducted four, 12 and 24 weeks after randomisation. The primary outcome
measures will be the Lower Extremity Functional Scale and the Assessment of Quality of Life.
Secondary outcomes will include measures of impairments, activity limitation and participation.
Data on the use of physiotherapy services and participants' out-of-pocket costs will be collected
for the cost-effective and cost-utility analyses. To test the effects of treatment, between-group
differences will be examined with analysis of covariance using a regression approach. The primary
conclusions will be based on the four-week follow-up data.
Discussion: This trial incorporates features known to minimise bias. It uses a pragmatic design to
reflect clinical practice and maximise generalisability. Results from this trial will contribute to an
evidence-based approach for rehabilitation after ankle fracture.
