AFTER – Ankle fracture treatment: enhancing rehabilitation trial
Not Applicable
- Conditions
- Ankle fractureMusculoskeletal Diseases
- Registration Number
- ISRCTN11830323
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 377
Inclusion Criteria
1. Patient is aged 50 years and over with an ankle fracture undergoing surgical fixation or nonsurgical management
2. Patient is provided with a cast or orthotic boot (non-removable or removable for non-weight bearing ankle movement) for at least 4 weeks and no longer than 10 weeks
3. Patient has capacity to consent to trial participation within 14 days of removal of the cast/boot
Exclusion Criteria
1. Patient is deemed unable to adhere to trial procedures or complete questionnaires
2. Patient was not ambulatory before the injury
3. Patient has contraindications to participation in an exercise programme
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ankle function measured by Olerud and Molander Ankle Scale (OMAS) at 6 months post randomisation
- Secondary Outcome Measures
Name Time Method 1. Ankle function measured by Olerud and Molander Ankle Scale (OMAS) at baseline and 2 and 4 months post randomisation.<br>2. Health-related quality of life measured by EQ-5D-5L at Baseline, 2, 4 and 6 months post-randomisation.<br>3. Pain, measured by pain sub-scales of the EQ-5D-5L and OMAS at Baseline, 2, 4 and 6 months post-randomisation.<br>4. Physical Function, measured by PROMIS Physical Function at Baseline, 4 and 6 months post-randomisation.<br>5. Self-efficacy measured by Self-Efficacy Exercise Score at Baseline, 4 and 6 months post-randomisation<br>6. Participant exercise adherence, measured with self-reported exercise frequency at 2, 4 and 6 months post-randomisation.<br>7. Participant complications, measured with complications questionnaire and Case Report Form at 2, 4 and 6 months post-randomisation.<br>8. Cost effectiveness of interventions measured with health economics questionnaire at 2 and 6 months post-randomisation