Ankle fracture Injury, Occupational Diseases, Poisoning Fractures of other parts of lower leg
Conditions
Interventions
This is a multicentre pilot randomised controlled trial with an embedded qualitative study. Participants will be allocated to best practice advice (one session of face-to-face advice delivered by a ph
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 50 years or over with an ankle fracture 2. Undergoing surgical fixation, or conservative management involving ankle immobilisation for at least 4 weeks
Exclusion criteria
Exclusion criteria: Patients who: 1. Are unable to understand spoken and written English 2. Do not have capacity to consent to study participation 3. Who were not ambulatory prior to the injury 4. Who are considered inappropriate for referral to physiotherapy (in the opinion of the clinician) 5. Who are unable to attend outpatient physiotherapy at a participating centre 6. With serious concomitant disease (such as terminal illness) 7. With avulsion fractures or other fractures not requiring surgery or immobilisation for definitive management 8. With bilateral lower limb fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a definitive RCT, assessed using the following success criteria: 1. Study participation rate of at least 25% of those eligible. Below this threshold would indicate lack of acceptability and there would be issues with generalisability 2. 48 eligible participants agree to participation over 3 sites over a maximum of 18 months (equivalent to at least 1 participant per month per site) 3. At least 85% of participants complete the study intervention sessions 4. At least 80% attend study follow-up at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The viability of measuring the following outcomes at 3 and 6-month follow-up: 1. Ankle-related symptoms and function, measured using the Olerud and Molander Ankle Score 2. Lower limb function, measured using the Lower Extremity Functional Scale 3. Pain, measured using Visual Analogue Scale 4. Health-related quality of life, measured using the EQ-5D-5L score 5. Fear of falls, measured using the Falls Efficacy Scale – International [short] 6. Self-efficacy, measured using the self-efficacy exercise score 7. Return to desired activities, including work, social life and sport activities (patient-reported) 8. Walking aid use and distance 9. Use of medications (patient-reported) 10. Work disability, measured using days off sick 11. Healthcare resource use (patient-reported) 12. Out-of-pocket expenses (patient-reported) 13. Adverse events 14. Adherence to exercise (patient-reported) 6-month follow-up only: 1. Ankle joint range, measured using hand-held goniometry 2. Muscle strength, measured using hand held dynamometry 3. Short Physical Performance Battery (SPPB) Embedded sub-study (optional participation): 1. The patients’ experiences of being recruited to a randomised trial of physiotherapy rehabilitation 2. What helps or hinders patient participation in the trial interventions and how this fits into their daily lives | — |
Countries
England, United Kingdom
Outcome results
None listed