Accelerometry and Rehabilitation After Knee Replacement Study (ARK): A Prospective, Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Completion of Oxford Knee Score (OKS) at 6 months from surgery
研究概览
简要总结
Total knee replacement (TKR) is a successful and cost-effective treatment for end-stage arthritis. Its usage is increasing due to changing population demographics and quality of life (QoL) expectations. There were almost 100,000 total knee replacements (TKR) performed in England between 2018/19. After TKR, patient engagement in their rehabilitation exercises is very important but physiotherapy services are very stretched at present especially in the covid-19 era. Patient compliance with their exercises is poor at about 25%.
The use of wearable sensors (WS) following TKR is gaining lots of interest especially in the post covid-era. A recent review found five small studies which supported the feasibility of their use. WS may help with patients to engage better with their rehabilitation exercises after surgery, delivering remote physiotherapy and potentially help identify patients who may be struggling more and therefore need further targeted help with physiotherapy.
Sensors have the potential to be a cost-saving intervention for the NHS by improving efficiencies in monitoring patients by reducing number of outpatient appointments, reducing rehabilitation time, improving patient's adherence to rehabilitation schedules and increasing confidence in exercise regimes leading to improved health-related quality of life. We will conduct the first large scale study where 250 patients having TKR will be randomly chosen to either receive a WS (125 patients) against 125 patients who will have standard care (SC). Patient reported outcomes (PROMs), pain scores, objective measures of knee function and data from the sensors on how well patients engaged with their exercises will be collected. The study will also assess if WS is cost effective, at 6 months after surgery.
This study has the potential to revolutionise how pre- and post-knee replacement rehabilitation is delivered, providing an individualised, cost effective and successful solution to the current status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •• Primary total knee replacement patients
- •Participant is aged 18 years of age or over
- •Participant is able and willing to provide written informed consent
- •Participant with ability to work with smart devices
- •Participant having own device (Apple iPhone or iPad or Android tablet or smartphone - minimum requirement: IOS - 12.4 or later/Android - 6.5 or later)
- •Internet connection at patient's home - either Wifi or mobile internet (min. 3G)
排除标准
- •• Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- •Participants with dementia or other cognitive impairment which would prevent them from using the sensor/app
- •Presence of a previous joint replacement in the same knee
- •Surgical treatment of involved knee within the past 6 months (excluding arthroscopy)
- •Previous orthopaedic surgery for trauma or arthritis of the knee joint (such as a previous fracture fixation or osteotomy)
- •Active cancer (currently diagnosed and under treatment)
- •Unable to complete all trial procedures (e.g. attend follow up visits, complete questionnaires)
- •Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
研究组 & 干预措施
Standard Care
Unsupervised home-based exercises following knee replacement
干预措施: Standard Care (in control arm) (Other)
Wearable Sensor
Remote monitoring of home-based exercises following knee replacement using a wearable sensor
干预措施: Remote monitoring of home-based exercises following knee replacement using a wearable sensor (Other)
结局指标
主要结局
Completion of Oxford Knee Score (OKS) at 6 months from surgery
时间窗: 6 months
Completion of Patient satisfaction at 6 months after surgery using a survey questionnaire.
Oxford Knee Score (OKS)
时间窗: Completion of Patient satisfaction at 6 months (primary outcome), in addition to baseline, pre-operative, 6 weeks, 12 months after surgery
The Oxford Knee Score (OKS) is a 12-item, patient-reported outcome measure designed to assess pain and physical function in patients undergoing total knee replacement, with total scores ranging from 0 to 48, where higher scores represent better joint function and minimal pain.
次要结局
- Knee Injury & Osteoarthritis Outcomes Score (KOOS)(Baseline, 6 weeks, 6 months)
- Self-Administered Patient Satisfaction (SAPS)(6 weeks, 6 months)
- EQ-5D-5L(Baseline, 6 weeks, 6 months, 12 months)
- Wong-Baker FACES Pain Rating Scale (WB-FPRS)(Baseline, 6 weeks, 6 months)
- Goniometric range of motion (ROM)(Baseline, 6 weeks, 6 months)
- Timed Up and Go (TUG)(Baseline, pre-operative, 6 weeks, 6 months)