Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
This study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.
详细描述
The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy sessions over 3 months. The investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. This may include activities such as hopping and changing direction which differentiates it from other programmes. Participants will be required to perform the exercise programme 3 times a week independently. Strategies to increase adherence to the exercise programme will also be used. This study is part of a Masters in Clinical Research funded by the National Institute for Health Research
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.
排除标准
- •Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
- •> 4 weeks from injury to presentation to acute care (ED or trauma services)
- •Unable to give written informed consent
- •Previous surgery on the affected knee
- •Presence of fracture on plain radiograph including osteochondral fractures
- •Medial patellar dislocation
- •Considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient)
- •History of severe neuromuscular or congenital disorders
- •Patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention
- •Unable to understand written or spoken English
- •Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient physiotherapy department
结局指标
主要结局
Recruitment Rate
时间窗: 15 weeks
Percentage of eligible participants who consented to participate in the study
Attrition
时间窗: 12 weeks
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Eligibility Rate
时间窗: 15 weeks
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Adherence
时间窗: 12 weeks
Percentage (0-100%) of scheduled physiotherapy sessions attended
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
时间窗: 12 weeks
Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)
Acceptability [Participant Satisfaction]: Questionnaire
时间窗: 12 weeks
Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.
次要结局
- Quality of Life Using the EQ-5D-5L Questionnaire(12 weeks)
- Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants](12 weeks)
- Tegner Activity Scale Questionnaire(12 weeks)
- Lyhsolm Knee Scoring Scale Questionnaire(12 Weeks)
- Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy](From date of injury until date of the first physiotherapy session, assessed up to 6 weeks)
- Acceptability of Outcome Data Collection(12 weeks)
- Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria(Baseline)
- Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists](12 weeks)
- Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists](12 weeks)
- Assess Delivery of the Intervention [Initial Injury Management](From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks)
- Number of Treatment Related Adverse Events Experienced by Participants(Through 12 weeks after first physiotherapy session)
- Assess Delivery of the Intervention [Duration of Intervention](12 weeks)