Incorporating Wearable Technology for Enhanced Rehabilitation Monitoring After Hip and Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,144
- 试验地点
- 1
- 主要终点
- Peak 1 Minute
研究概览
简要总结
This study focuses on the impact of osteoarthritis (OA), a leading cause of disability among older adults, with the hip and knee joints being particularly affected. The rise in OA prevalence is attributed to factors such as aging and increasing obesity rates. Post-surgery rehabilitation, especially after total hip or knee replacement, traditionally relies on supervised clinical assessments, which have limitations in capturing real-world experiences. The study aims to explore the integration of technology-assisted rehabilitation, utilizing wearable sensors and mobile health technologies, for unsupervised, real-world assessments. The use of digital biomarkers collected from these technologies offers continuous, objective measurements of patients' biological and physiological data. The research employs a dataset from moveUP digital therapies, including patients who underwent total knee arthroplasty, utilizing a digital application for at least six weeks post-surgery.
Key objectives include evaluating the potential of automated unsupervised assessments in providing a holistic understanding of patient progression during rehabilitation. The study utilizes mixed models for statistical analysis, examining outcomes such as steps per day, 6-minute walk test, and peak 1 minute. Results indicate differences in recovery trajectories between hip and knee patients, with variations based on gender and type of prosthesis.
详细描述
Data Source:
This retrospective observational study utilized anonymized and depersonalized data from the moveUP digital therapies database (moveUP solution, Brussels, Belgium). The database encompasses information from patients who underwent hip and knee arthroplasty across Belgium, France, and the Netherlands. A cohort of 1144 patients who underwent elective total knee arthroplasty was selected based on their use of the digital application for a minimum of 6 weeks post-surgery, with completion of preoperative patient-reported outcome measures. Written informed consent for the scientific use of anonymized data was obtained from each patient. Regulatory guidelines were adhered to, and no institutional review board (IRB) approval was required, given the use of anonymized patient-level data.
Recording Device and Outcomes:
All data collection occurred through the moveUP® application, a registered medical device operating on a smart virtual platform designed for digital monitoring. This platform comprises a patient-facing mobile application and a web-based dashboard utilized by care providers. Objective data, including the number of steps per day and steps per minute, were collected using a commercial activity tracker (Garmin Vivofit 4) worn 24/7 by patients throughout the rehabilitation period. Patient-reported outcomes, such as the Oxford Knee Score, Forgotten Joint Score (FJS), Hip Osteoarthritis Outcome score (KOOS), Knee Osteoarthritis Outcome score (KOOS), UCLA Activity Scale (UCLA), and the EuroQol 5-Dimension (EQ5D), were measured before surgery and at various intervals up to two years post-surgery through the app.
Statistical Analysis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Persons with Hip or Knee Replacement surgery
- •minimum 18 years of age
- •Patient has emailadres
- •use of application for at least 6 weeks postop
- •completion of preoperative questionnaire
排除标准
- •Patient younger than 18 years of age
- •no emailadres
结局指标
主要结局
Peak 1 Minute
时间窗: pre and 6 weeks post surgery
Refers to the walking performance measured during a one-minute interval
steps per day
时间窗: pre and 6 weeks post surgery
This parameter represents the daily step count of patients. Monitoring steps per day is a common metric for assessing mobility and physical activity during rehabilitation.
6 minute walking test
时间窗: pre and 6 weeks post surgery
he 6-minute walk test is a standard measure of functional capacity and endurance. Patients are assessed on the distance they can walk in six minutes, providing valuable information about their cardiovascular and musculoskeletal function
Intensity
时间窗: pre and 6 weeks post surgery
intensity of physical activity, specifically focusing on activities classified as moderate-to-vigorous. This parameter provides information about the intensity of patients' physical efforts during rehabilitation
次要结局
未报告次要终点