Ankle FractureEVAR-AcceptNCT07751107
Early Virtual Ankle Rehabilitation (EVAR): Acceptability
A study testing EVAR and EMADE in people with Ankle Fracture, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- EVAR and EMADE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Academic Orthopaedics and Trauma
Nottingham, Nottinghamshire, NG7 2UH
Paul A. Matthews, PhD, +44 (0)1159249924 ext. 87502, Paul.Matthews27@nhs.nhs
Jessica Nightingale, PhD, +44 (0) 7810326600, jessica.nightingale3@nhs.net
About this study
Official title: Early Virtual Ankle Rehabilitation (EVAR): A Proof-of-concept Feasibility Study Exploring Patient Acceptability Using Qualitative Interviews With Nested Quantitative Analysis.
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:
Read more
- 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.
Read the 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.
- Conditions
- Ankle Fracture
- Being tested
- EVAR, EMADE
- Keywords
- Physical therapy, Physiotherapy, Exercise, Rehabilitation, Virtual, Remote
- Medical subject headings
- Ankle Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVAROther
Physiotherapy sessions delivered through virtual/remote clinics.
EMADEOther
Physiotherapy review sessions are delivered through the participant attending the hospital for face-to-face clinics.
| Study group | Role | What they receive |
|---|---|---|
| EVAR | Experimental | Early Virtual Ankle Rehabilitation (EVAR) Receives: Other: EVAR |
| EMADE | Active comparator | Early Motion and Directed Exercise (EMADE) Receives: Other: EMADE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After completion of the early rehabilitation phase at approximately week-6 post surgery
Secondary outcomes (9)
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.
Measured: Up to week-12 post surgery
Retention rates
A higher frequency of retention will strengthen the feasibility of future trials.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: Up to week-12 post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start22 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, Paul Matthews, University of Nottingham
- Investigators
- Ben A Marson, FRCS, PhD, Study director, Orthopaedics & Trauma & Biomedical Research Centre, School of Medicine, University of Nottingham, UKBen J Ollivere, FRCS, MD., Study chair, Deputy Pro-Vice Chancellor. Chair of Orthopaedic Trauma, School of Medicine. Uni of Nottingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751107
- Sponsor's protocol ID
- IRAS ID: 356614
- Other IDs
- FR-000003450/19GOR006, R&I: 26OR003
- Acronym
- EVAR-Accept
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34593508Rankin 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.
PubMed 32026816Bretherton 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.
PubMed 34848529Sekhon 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.
PubMed 28126032Matthews 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.
PubMed 39216862
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Virtual Ankle Rehabilitation (EVAR): A Proof-of-concept Feasibility Study Exploring Patient Acceptability Using Qualitative Interviews With Nested Quantitative Analysis.
- ClinicalTrials.gov ID
- NCT07751107
- Acronym / sponsor ID
- EVAR-Accept / IRAS ID: 356614
- Conditions
- Ankle Fracture
- Keywords
- Physical therapy, Physiotherapy, Exercise, Rehabilitation, Virtual, Remote
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust
- Study start
- 22 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVAR | Experimental | Other: EVAREarly Virtual Ankle Rehabilitation (EVAR) |
| EMADE | Active comparator | Other: EMADEEarly Motion and Directed Exercise (EMADE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVARPhysiotherapy sessions delivered through virtual/remote clinics. | Other | EVAR |
| EMADEPhysiotherapy review sessions are delivered through the participant attending the hospital for face-to-face clinics. | Other | EMADE |
Primary outcome
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
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 34593508Skivington 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.
- Background: PubMed 32026816Rankin 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.
- Background: PubMed 34848529Bretherton 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.
- Background: PubMed 28126032Sekhon 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.
- Background: PubMed 39216862Matthews 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben A Marson, FRCS, PhD study director
Orthopaedics & Trauma & Biomedical Research Centre, School of Medicine, University of Nottingham, UK
Ben J Ollivere, FRCS, MD. study chair
Deputy Pro-Vice Chancellor. Chair of Orthopaedic Trauma, School of Medicine. Uni of Nottingham, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVAR and EMADE in people with Ankle Fracture, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul A Matthews, PhD. (+44 (0)1159249924 ext. 87502, Paul.Matthews3@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07751107, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.