Early Virtual Ankle Rehabilitation (EVAR): Acceptability

NCT07751107 | Not Yet Recruiting

• 3 other identifiers: IRAS ID: 356614FR-000003450/19GOR006R&I: 26OR003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Fracture

Keywords

Physical therapy; Physiotherapy; Exercise; Rehabilitation; Virtual; Remote

Outcome Measures

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.

  After completion of the early rehabilitation phase at approximately week-6 post surgery

Secondary Outcomes (9)

• The Screened, Eligible, Approached, and Recruited (SEAR) framework

  Up to week-12 post surgery

• Retention rates

  Up to week-12 post surgery

• Crossover rates

  Up to week-12 post surgery

• Rates of unplanned clinical reviews

  Up to week-12 post surgery

• Adverse event rates

  Up to week-12 post surgery

Study Arms (2)

EVAR

EXPERIMENTAL

Early Virtual Ankle Rehabilitation (EVAR)

Other: EVAR

EMADE

ACTIVE COMPARATOR

Early Motion and Directed Exercise (EMADE)

Other: EMADE

Interventions

EVAR OTHER

Physiotherapy sessions delivered through virtual/remote clinics.

EVAR

EMADE OTHER

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

EMADE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham Biomedical Research Centre: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Academic Orthopaedics and Trauma

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (5)

• 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 BACKGROUND

• 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;107:161-168. doi: 10.1016/j.physio.2019.07.006. Epub 2019 Jul 29.

  PMID: 32026816 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Motor Activity

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Behavior

Study Officials

• Ben A Marson, FRCS, PhD

  Orthopaedics & Trauma & Biomedical Research Centre, School of Medicine, University of Nottingham, UK

  STUDY DIRECTOR

• Ben J Ollivere, FRCS, MD.

  Deputy Pro-Vice Chancellor. Chair of Orthopaedic Trauma, School of Medicine. Uni of Nottingham, UK

  STUDY CHAIR

Central Study Contacts

Paul A Matthews, PhD.

CONTACT

+44 (0)1159249924; Paul.Matthews3@nottingham.ac.uk

Jessica Nightingale, PhD.

CONTACT

+44 (0) 7810326600; jessica.nightingale3@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Physiotherapist

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 7, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)