Early Virtual Ankle Rehabilitation (EVAR): Acceptability

Official title

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

Overview

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.

Detailed description

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.

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.

Primary outcome measures

• A qualitative exploration and comparison of participant experiences and perceptions of the acceptability of EVAR and EMADE methods of receiving early ankle rehabilitation. [Time frame: After completion of the early rehabilitation phase at approximately week-6 post surgery]

Secondary outcome measures (9)

• The Screened, Eligible, Approached, and Recruited (SEAR) framework [Time frame: Up to week-12 post surgery]
• Retention rates [Time frame: Up to week-12 post surgery]
• Crossover rates [Time frame: Up to week-12 post surgery]
• Rates of unplanned clinical reviews [Time frame: Up to week-12 post surgery]
• Adverse event rates [Time frame: Up to week-12 post surgery]
• UK General Practice Physical Activity Questionnaire (GPPAQ) [Time frame: Up to week-12 post surgery.]
• Quantified Acceptability [Time frame: Up to week-12 post surgery.]
• Olerud-Molander Ankle Score (OMAS) [Time frame: Up to week-12 post surgery.]
• Health-related quality of life (HRQoL) [Time frame: Up to week-12 post surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United Kingdom · 1 center

• Academic Orthopaedics and Trauma — Nottingham

Publications

• Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061. PMID 34593508
• Rankin G, Summers R, Cowan K, Barker K, Button K, Carroll SP, Fashanu B, Moran F, O'Neill B, Ten Hove R, Waterfield J, Westwater-Wood S, Wellwood I; James Lind Alliance (JLA) Physiotherapy Priority Setting Partnership (PSP) Steering Group. Identifying Priorities for Physiotherapy Research in the UK: the James Lind Alliance Physiotherapy Priority Setting Partnership. Physiotherapy. 2020 Jun;107:161 PMID 32026816
• Bretherton CP, Claireaux HA, Gower J, Martin S, Thornhill A, Johnson L, Silvester L, Kearney RS, Baxter M, Dixon P, Giblin V, Griffin XL, Eardley W. Research priorities for the management of complex fractures: a UK priority setting partnership with the James Lind Alliance. BMJ Open. 2021 Nov 30;11(11):e057198. doi: 10.1136/bmjopen-2021-057198. PMID 34848529
• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8. PMID 28126032
• Matthews PA, Scammell BE, Coughlin TA, Nightingale J, Ollivere BJ. Early Motion and Directed Exercise (EMADE) following ankle fracture fixation: a pragmatic randomized controlled trial. Bone Joint J. 2024 Sep 1;106-B(9):949-956. doi: 10.1302/0301-620X.106B9.BJJ-2023-1433.R1. PMID 39216862

Identifiers

NCT: NCT07751107 · IRAS ID: 356614 · FR-000003450/19GOR006 · R&I: 26OR003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗