Early Virtual Ankle Rehabilitation (EVAR): Acceptability
ConditionAnkle Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nottingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EVAR
Other interventionPhysiotherapy sessions delivered through virtual/remote clinics.
EMADE
Other interventionPhysiotherapy review sessions are delivered through the participant attending the hospital for face-to-face clinics.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: EVARExperimental treatment 1 intervention
Group B: EMADEActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
A qualitative exploration and comparison of participant experiences and perceptions of the acceptability of EVAR and EMADE methods of receiving early ankle rehabilitation.
Qualitative data will be collected from the participants through semi-structured interviews. The Theoretical Framework of Acceptability (TFA) will be applied to these interviews. The TFA consists of seven key domains; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy, plus general acceptability. The method of analyses will use framework analysis.
Time frame
After completion of the early rehabilitation phase at approximately week-6 post surgerySecondary outcomes
1
The Screened, Eligible, Approached, and Recruited (SEAR) framework
The SEAR framework is a structured approach for tracking participant recruitment in randomised controlled trials (RCTs). It categorises individuals at each of the stages; screening, eligible checks, those approached, and those recruited. Although not a scaled outcome, the SEAR framework enhances transparency, identifies barriers, and improves trial enrolment strategies. Data will be collected as part of the screening log.
Time frame
Up to week-12 post surgery2
Retention rates
A higher frequency of retention will strengthen the feasibility of future trials.
Time frame
Up to week-12 post surgery3
Crossover rates
A higher frequency of crossovers may suggest the unacceptability of with one or both groups. Where applicable, events leading to crossover will be explored during qualitative interviews.
Time frame
Up to week-12 post surgery4
Rates of unplanned clinical reviews
A higher frequency of unplanned clinical reviews may suggest the unacceptability of one or both groups. Where applicable, events leading to crossover will be explored during qualitative interviews.
Time frame
Up to week-12 post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nottingham
Lead sponsor
Nottingham Biomedical Research Centre
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov
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