Early Virtual Ankle Rehabilitation (EVAR): A Proof-of-concept Feasibility Study Exploring Patient Acceptability Using Qualitative Interviews With Nested Quantitative Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A qualitative exploration and comparison of participant experiences and perceptions of the acceptability of EVAR and EMADE methods of receiving early ankle rehabilitation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
EVAR
Early Virtual Ankle Rehabilitation (EVAR)
干预措施: EVAR (Other)
EMADE
Early Motion and Directed Exercise (EMADE)
干预措施: EMADE (Other)
结局指标
主要结局
A qualitative exploration and comparison of participant experiences and perceptions of the acceptability of EVAR and EMADE methods of receiving early ankle rehabilitation.
时间窗: 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.
次要结局
- 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)
- UK General Practice Physical Activity Questionnaire (GPPAQ)(Up to week-12 post surgery.)
- Quantified Acceptability(Up to week-12 post surgery.)
- Olerud-Molander Ankle Score (OMAS)(Up to week-12 post surgery.)
- Health-related quality of life (HRQoL)(Up to week-12 post surgery.)
研究者
Paul Matthews
Clinical Research Physiotherapist
University of Nottingham