None listed
Conditions
Brief summary
This study will determine if rehabilitation programs for people with ankle pain and stiffness following immobilisation for ankle fracture produce clinically worthwhile effects and are cost-effective.
Interventions
Participants randomised to the treatment (rehabilitation) group will receive the advice intervention (see control treatment for details) plus participate in a program that is designed, monitored and progressed by a physiotherapist. The focus of this program is exercise. Three types of exercises will be prescribed - ankle mobility and strengthening exercises, stepping exercises, and exercises involving weight bearing and balancing on the affected leg. Participants will receive about five treatmen
Participants randomised to the treatment (rehabilitation) group will receive the advice intervention (see control treatment for details) plus participate in a program that is designed, monitored and progressed by a physiotherapist. The focus of this program is exercise. Three types of exercises will be prescribed - ankle mobility and strengthening exercises, stepping exercises, and exercises involving weight bearing and balancing on the affected leg. Participants will receive about five treatments (one or two treatment sessions in the first week then one session per week for the next 3 weeks). The first session will take up to 60 minutes and the subsequent sessions will take up to 30 minutes. Participants will be encouraged to perform a carefully structured exercise program at home between physiotherapy appointments, which they will record in an exercise diary. The exact number of treatments and the timing of discharge are not mandated by the trial protocol. Participants will be discharged by their physiotherapists when they return to their previous level of function, reach a plateau in their progress, or choose to discontinue treatment. Participants will also receive gait training and ongoing advice about returning to their usual work and leisure activities. Other physiotherapy interventions (e.g. manual therapy and passive stretching) may be administered in conjunction with the exercise program if deemed appropriate. Where it is deemed appropriate, participants will be instructed to use ice for pain relief and compression and elevation for management of swelling. A compression bandage (i.e. tubigrip) will be provided if required.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ankle fracture treated with immobilisation (with or without surgical fixation) 2. immobilisation removed on the day of recruitment 3. approval received from orthopaedic specialist to weight-bear as tolerated or partial weight-bear 4. reduced ankle dorsiflexion range of motion (at least 30 mm less motion compared to the non-fractured leg using the weight-bearing lunge method) 5. experiences at least 2 out of 10 pain in the ankle when up to 50% of body weight is borne through the affected leg 6. completed skeletal growth (i.e. no evidence of epiphyseal cartilage in the tibia in x-rays taken for fracture management) 7. no concurrent pathologies (e.g. symptomatic osteoarthritis, stroke, other fractures) which affect the ability to perform everyday tasks or the measurement procedures used in this study, and 8. provides informed consent.
Exclusion criteria
Nil in addition to criteria stated under key inclusion criteria
Outcome results
None listed