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.
Background: Ankle fractures are common injuries that frequently require surgical fixation. Traditional rehabilitation pathways may delay physiotherapy until approximately 6 weeks after surgery and following removal of ankle immobilisation and weight-bearing restrictions. This delay may contribute to pain, stiffness, swelling, muscle weakness, reduced function, and other barriers to recovery. The James Lind Alliance highlights priorities such as optimal outpatient rehabilitation strategies and effective physiotherapy service delivery. Previously, the Early Motion and Directed Exercise (EMADE) programme, applied during the early post-operative period (between week-2 and week-6 post surgery), demonstrated accelerated recovery while maintaining safety. However, EMADE required additional face-to-face physiotherapy appointments, which was inconvenient for some patients struggling to travel and place additional demands on outpatient services. The increasing availability and acceptance of virtual healthcare technologies has created opportunities to deliver rehabilitation remotely. Early Virtual Ankle Rehabilitation (EVAR) was developed to provide physiotherapy review sessions using virtual consultation technology while retaining the same rehabilitation programme previously evaluated in EMADE. EVAR is delivered through the host hospital's secure NHS-approved virtual consultation technology already used for remote physiotherapy and clinical reviews. This was chosen for its user-friendliness and accessibility for patients. In addition to video calls participants may submit photos or videos of themselves performing their exercises for purpose of monitoring wound healing and verifying exercise technique. In line with the Medical Research Council framework for complex interventions, it is crucial to first evaluate whether the virtual rehabilitation model of EVAR is acceptable to the patient group and feasible in a future research design. Study Aim: The aim of this study is to explore patient experiences and perceptions of the acceptability of EVAR following ankle fracture surgery. Findings will inform the design of a future definitive trial evaluating the effectiveness and implementation of EVAR. Study Design: This is a single-centre proof-of-concept feasibility study using qualitative interviews with nested quantitative analyses. Adults undergoing surgical fixation of an ankle fracture will be recruited from fracture clinics at Nottingham University Hospitals NHS Trust. Following consent and baseline assessment, participants will be randomised (employing random permuted blocks of 3 and 6) in a 2:1 ratio to EVAR or EMADE. The 2:1 allocation ratio has been selected to generate a richer dataset of patient experiences of EVAR being the newer rehabilitation delivery model under evaluation, while retaining a comparator group. The content of the early ankle rehabilitation will be identical for both groups with the only group difference being the method used to deliver the physiotherapy sessions. Rehabilitation Programme: The early ankle rehabilitation commences following the routine fracture clinic review at approximately 2 weeks after surgery and continuing until the subsequent orthopaedic review, usually at 6 weeks post-surgery. The programme includes progressive ankle range-of-motion exercises, gentle strengthening exercises, education, rehabilitation guidance, and safety-netting advice. The exercises are conducted in the patient's home and in sitting of lying. Intervention Delivery: Participants allocated to EVAR will receive two physiotherapy review sessions remotely using the virtual consultation technology. Participants allocated to EMADE will receive two physiotherapy review sessions face-to-face in hospital outpatient settings. Where clinically indicated, participants may receive additional reviews. Acceptability Assessment: Acceptability will be evaluated using the Theoretical Framework of Acceptability (TFA) the domains of which include; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy, and overall acceptability. On completion of the early rehabilitation (at approximate week-6 post surgery) all participants will be invited to a one-on-one semi-structured interviews based on the TFA. The interviews will be conducted by an experienced qualitative researcher working independent of the care delivery team. Interviews will be audio-recorded, transcribed verbatim, and analysed using Framework Analysis informed by the TFA. Feasibility Outcomes: In addition to qualitative findings, quantitative measures will be collected to inform future trial design. These include participant recruitment and retention, questionnaire completion, intervention acceptability, crossover rates, unplanned clinical reviews, recovery measures, adverse events, and other feasibility indicators. Data will be analysed descriptively and used to inform progression to a future definitive trial. Sample Size: As a qualitative feasibility study, a formal power calculation has not been performed. Recruitment of approximately 21 to 30 participants is anticipated to provide sufficient diversity of experiences to achieve data saturation and evaluate intervention acceptability. Recruitment may cease once saturation has been achieved.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Academic Orthopaedics and Trauma
Nottingham, Nottinghamshire, United Kingdom
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 surgery
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 surgery
Retention rates
A higher frequency of retention will strengthen the feasibility of future trials.
Time frame: Up to week-12 post surgery
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 surgery
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 surgery
Adverse event rates
A higher frequency of adverse events may suggest unacceptability in one or both groups. Where applicable, events leading to crossover will be explored during qualitative interviews.
Time frame: Up to week-12 post surgery
UK General Practice Physical Activity Questionnaire (GPPAQ)
The GPPAQ is a tool used to assess a participant's physical activity level based on their occupational and leisure-time activities. It categorises patients into four activity levels: inactive, moderately inactive, moderately active, and active.
Time frame: Up to week-12 post surgery.
Quantified Acceptability
Acceptability will be quantified using the theoretical framework of acceptability (TFA) questionnaire. The TFA consists of seven key domains; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy, plus general acceptability. The participants complete the questionnaire using a 1-to-5 Likert-style format. The following ratings will apply: ≥ 4 good acceptance, 3 acceptable and ≤2 unacceptable .
Time frame: Up to week-12 post surgery.
Olerud-Molander Ankle Score (OMAS)
The OMAS measures ankle symptom and function recovery and consists of nine Likert-style questions: three symptom- and six function-focused questions and is scored 0-100; poorest to best, respectively. The OMAS scores from 0 total impairment to 100 complete unimpairment.
Time frame: Up to week-12 post surgery.
Health-related quality of life (HRQoL)
The EuroQol EQ-5D-5L is a standardised HRQoL questionnaire used to assess general health status. It consists of two main components: the EQ-5D-5L descriptive system and a visual analogue scale (VAS). The descriptive system consists of 5 domains; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and for each the participant self-rates their status across 5 levels; no problem, slight, moderate, severe or unable/extreme. On the VAS the participant rates their health from 0 - worst health you can imagine, to 100 - best health you can imagine.
Time frame: Up to week-12 post surgery.
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