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).