Distal radius fracture Injury, Occupational Diseases, Poisoning Fracture of lower end of radius
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 50 years and older 2. Distal radius fracture treated surgically or non-surgically 3. Informed consent for participation in the study
Exclusion criteria
Exclusion criteria: 1. Injury is more than 2 months old 2. There is evidence that the patient would be unable to participate in therapy or a self-guided exercise programme provided by a participating centre or adhere to trial procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome) 3. Open fractures with a Gustilo & Anderson grading >1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main aim of the feasibility randomised controlled trial is to determine whether a future definitive trial would be feasible. To determine the feasibility of a definitive RCT the success criteria are: 1. Patient engagement with the trial, measured by recruitment rate over 6 months of recruitment 2. Acceptability of the interventions, as measured by adherence (number and content of therapy appointments attended/website visits) and patient/staff interviews over 6 months of recruitment 3. Participant retention, as measured by the proportion of randomised patients providing outcome data at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The researchers will collect the proposed definitive trial outcome measures as part of this feasibility study to determine their viability in a future definitive trial. 1. Wrist pain and function measured using Patient Reported Wrist Evaluation (PRWE) at baseline, 3 and 6 months 2. Upper extremity function measured using PROMIS Upper Extremity at baseline, 3 and 6 months 3. Confidence in ability to do exercise measured using Self-efficacy Exercise Score (SEE) at baseline, 3 and 6 months 4. Self-reported exercise frequency measured using a trial-specific questionnaire at 3 and 6 months 5. Health-related quality of life measured using EQ-5D-5L at baseline, 3 and 6 months 6. Self-reported health resource use measured using a trial-specific questionnaire at 3 and 6 months 7. Reporting of adverse events using patient questionnaires and site complication at baseline, 3 and 6 months 8. Muscle strength measured using a dynamometer at 6 months 9. Balance and mobility measured using a trial-specific questionnaire at baseline, 3 and 6 months | — |
Countries
England, United Kingdom