Technological advances in multimodal wearable and connected devices have enabled the measurement of human movement and physiology in naturalistic settings. The ability to collect continuous activity ...monitoring data with digital devices in real-world environments has opened unprecedented opportunity to establish clinical digital phenotypes across diseases. Many traditional assessments of physical function utilized in clinical trials are limited because they are episodic, therefore, cannot capture the day-to-day temporal fluctuations and longitudinal changes in activity that individuals experience. In order to understand the sensitivity of gait speed as a potential endpoint for clinical trials, we investigated the use of digital devices during traditional clinical assessments and in real-world environments in a group of healthy younger (
= 33, 18-40 years) and older (
= 32, 65-85 years) adults. We observed good agreement between gait speed estimated using a lumbar-mounted accelerometer and gold standard system during the performance of traditional gait assessment task in-lab, and saw discrepancies between in-lab and at-home gait speed. We found that gait speed estimated in-lab, with or without digital devices, failed to differentiate between the age groups, whereas gait speed derived during at-home monitoring was able to distinguish the age groups. Furthermore, we found that only three days of at-home monitoring was sufficient to reliably estimate gait speed in our population, and still capture age-related group differences. Our results suggest that gait speed derived from activities during daily life using data from wearable devices may have the potential to transform clinical trials by non-invasively and unobtrusively providing a more objective and naturalistic measure of functional ability.
Background: Traditional measurement systems utilized in clinical trials are limited because they are episodic and thus cannot capture the day-to-day fluctuations and longitudinal changes that ...frequently affect patients across different therapeutic areas. Objectives: The aim of this study was to collect and evaluate data from multiple devices, including wearable sensors, and compare them to standard lab-based instruments across multiple domains of daily tasks. Methods: Healthy volunteers aged 18–65 years were recruited for a 1-h study to collect and assess data from wearable sensors. They performed walking tasks on a gait mat while instrumented with a watch, phone, and sensor insoles as well as several speech tasks on multiple recording devices. Results: Step count and temporal gait metrics derived from a single lumbar accelerometer are highly precise; spatial gait metrics are consistently 20% shorter than gait mat measurements. The insole’s algorithm only captures about 72% of steps but does have precision in measuring temporal gait metrics. Mobile device voice recordings provide similar results to traditional recorders for average signal pitch and sufficient signal-to-noise ratio for analysis when hand-held. Lossless compression techniques are advised for signal processing. Conclusions: Gait metrics from a single lumbar accelerometer sensor are in reasonable concordance with standard measurements, with some variation between devices and across individual metrics. Finally, participants in this study were familiar with mobile devices and had high acceptance of potential future continuous wear for clinical trials.
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