PDF(Pubmed)
Abstract：
Digital health technologies (DHTs) are increasingly being adopted in clinical trials, as they enable objective evaluations of health parameters in free-living environments. Although lumbar accelerometers notably provide reliable gait parameters, embedding accelerometers in chest devices, already used for vital signs monitoring, could capture a more comprehensive picture of participants\' wellbeing, while reducing the burden of multiple devices. Here we assess the validity of gait parameters measured from a chest accelerometer. Twenty healthy adults (13 females, mean ± sd age: 33.9 ± 9.1 years) instrumented with lumbar and chest accelerometers underwent in-lab and outside-lab walking tasks, while monitored with reference devices (an instrumented mat, and a 6-accelerometers set). Gait parameters were extracted from chest and lumbar accelerometers using our open-source Scikit Digital Health gait (SKDH-gait) algorithm, and compared against reference values via Bland-Altman plots, Pearson\'s correlation, and intraclass correlation coefficient. Mixed effects regression models were performed to investigate the effect of device, task, and their interaction. Gait parameters derived from chest and lumbar accelerometers showed no significant difference and excellent agreement across all tasks, as well as good-to-excellent agreement and strong correlation against reference values, thus supporting the deployment of a single multimodal chest device in clinical trials, to simultaneously measure gait and vital signs.Trial Registration: The study was reviewed and approved by the Advarra IRB (protocol number: Pro00043100).
摘要：
数字健康技术(DHTs)越来越多地被用于临床试验。因为它们能够对自由生活环境中的健康参数进行客观评估。虽然腰椎加速度计特别提供可靠的步态参数，在胸部装置中嵌入加速度计，已经用于生命体征监测，可以更全面地了解参与者的福祉，同时减少多个设备的负担。在这里，我们评估从胸部加速度计测量的步态参数的有效性。20名健康成年人（13名女性，平均±sd年龄：33.9±9.1岁）使用腰椎和胸部加速度计进行实验室内和实验室外步行任务，在用参考设备(仪表垫，和6个加速度计组)。使用我们的开源Scikit数字健康步态（SKDH-步态）算法从胸部和腰部加速度计中提取步态参数，并通过Bland-Altman地块与参考值进行比较，皮尔森的相关性，和组内相关系数。进行了混合效应回归模型来研究设备的影响，任务,和他们的互动。从胸部和腰部加速度计得出的步态参数在所有任务中没有显着差异并且具有极好的一致性，以及与参考值的良好一致性和强相关性，从而支持在临床试验中部署单一的多模式胸器，同时测量步态和生命体征。试验注册:该研究由AdvarraIRB审查和批准(方案号:Pro00043100)。
