An interventional study of EVAR and EMADE in Ankle Fracture, sponsored by University of Nottingham. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University of Nottingham · Not applicable, Interventional, and Other
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:
Participants will be put into one of two groups by chance:
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:
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
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Eligibility Criteria:
Adults who have undergone ankle fracture surgery
Inclusion Criteria:
Exclusion Criteria:
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:
Inability to adhere to study procedures, including, but not limited to, the following:
Early Virtual Ankle Rehabilitation (EVAR)
Other: EVAR
Early Motion and Directed Exercise (EMADE)
Other: EMADE
Physiotherapy sessions delivered through virtual/remote clinics.
Physiotherapy review sessions are delivered through the participant attending the hospital for face-to-face clinics.
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.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jun 2027, 11 months later.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 11 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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