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NCT07751107

Early Virtual Ankle Rehabilitation (EVAR): Acceptability

Sponsor: University of Nottingham

View on ClinicalTrials.gov

Summary

The goal of this study is to learn about people's experiences of how physiotherapy is received having recently had surgery for a broken ankle. The ways to receive the rehabilitation will be via video, call Early Virtual Ankle Rehabilitation (EVAR), and face-to-face at the hospital. The content of the rehabilitation programme will be the same for both groups. The main questions that the study aims to answer are: * During the early weeks of recovery after ankle surgery, how happy are people to have physiotherapy support by video call (EVAR) compared with face-to-face appointments at the hospital? * Is it practical to run a larger study on how well EVAR helps recovery from ankle fracture surgery? Participants will be put into one of two groups by chance: * A group that has EVAR, with physiotherapy appointments by video call to their home. * A group that has face-to-face physiotherapy appointments at the hospital. All participants will receive the same early physiotherapy programme. The only difference between the groups is how physiotherapy support is received. Participants in both groups will: * Start the physiotherapy programme at about 2-weeks after surgery. * Receive advice and information about recovery. * Carry out ankle exercises at home, while sitting or lying. * Have at least two physiotherapy appointments between 2 and 6 weeks after surgery. * At week-6, take part in an interview to explore the experiences of the physiotherapy programme and method of interacting with the physiotherapist. * Complete questionnaires about their recovery and their experiences, with a final set at about 12 weeks after surgery. Between 21 to 30 adults who have had surgery for a broken ankle will take part in this study. About twice as many participants will have physiotherapy appointments by video call as those who have appointments at the hospital. The information from this study will help researchers understand whether physiotherapy support by video call are a good fit for people recovering from ankle surgery. It will also help decide whether a larger study should be carried out in the future.

Official title: Early Virtual Ankle Rehabilitation (EVAR): A Proof-of-concept Feasibility Study Exploring Patient Acceptability Using Qualitative Interviews With Nested Quantitative Analysis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-22

Completion Date

2027-09-30

Last Updated

2026-08-07

Healthy Volunteers

Conditions

Ankle Fracture

Interventions

OTHER

EVAR

Physiotherapy sessions delivered through virtual/remote clinics.

OTHER

EMADE

Physiotherapy review sessions are delivered through the participant attending the hospital for face-to-face clinics.

Eligibility Criteria: Adults who have undergone ankle fracture surgery Inclusion Criteria: * Adults of either sex, aged 18 years and older, with no upper limit. * Within the last 21 days, they underwent open reduction and internal fixation (ORIF) for an ankle fracture; AO44, AO43B and AO43C classifications and subclassifications. * Any orthopaedic weightbearing instructions, ranging from non-weightbearing to unrestricted weightbearing. Exclusion Criteria: * Unable or unwilling to give informed written consent for any reason. * Unable or unwilling to engage with the early ankle rehabilitation programme. * Severe open fractures (Gustilo Anderson G3) * A clinical decision was made that the ankle should remain cast immobilised until the subsequent orthopaedic review, which is beyond 21 days post-surgery. * If, in the opinion of the clinical and research staff, it is in the patient's best interest to be excluded due to presentations such as, but not limited to: * Soft tissue concerns where early movement may risk tissue breakdown. * Comorbidities associated with slowed tissue healing, such as non-healing leg/foot ulcers, medicating diabetics and a lack of protective distal sensation (e.g. peripheral neuropathy). * There is a plausible concern that the individual has been or will be non-compliant with the most recent treatment advice, for example, weightbearing contrary to orthopaedic advice. * Inability to adhere to study procedures, including, but not limited to, the following: * Lacking the capacity to adhere to the study intervention (minor assistance from family and friends is permissible). * Unable to converse fluently in English for the interviews or lack the capacity or ability to complete the study questionnaire in English. * Does not have access to and/or rudimentary capacity to use virtual clinic technology (assistance from family and friends is permissible). * Currently taking part or having taken part in a research study in the last 3 months that involves/involved invasive procedures. Where the circumstances of a potential participant are ambiguous, clarification with the CI or PI should be sought.

Locations (1)

Academic Orthopaedics and Trauma

Nottingham, Nottinghamshire, United Kingdom