Objective: To collect and evaluate data from multiple devices including wearable and ambient sensors while performing tasks such as speech, gait, and scripted activities of daily living (sADL).

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 occur in patients with movement disorders. Increasing technological advances in wearable sensors and monitoring devices have the power to transform clinical trials by non-invasively and unobtrusively providing a more quantitative and naturalistic measure of daily activities and quality of life. The Pfizer Innovation Research (PfIRe) Lab is a state of the art motion capture lab, which enables the assessment of digital devices against other clinical and technological measures. The lab also allows for detailed assessment of device data handling, usability, storage capacity, and battery life before deployment in clinical trials.

Methods: Healthy volunteers aged 18-65 years are recruited for a one-hour study to collect and assess data from wearable sensors and ambient monitors. Participants first have their laterality handedness quotient determined and complete the Mobile Device Proficiency Questionnaire. They perform gait, posture, speech, and sADL tasks on a gait mat while instrumented with a watch, phone and motion insoles. They are simultaneously monitored by an image-based motion capture system (SIMI®). At the end of the study, participants complete a questionnaire to evaluate the comfort and tolerability of wearables.

Results: Data from the wearability questionnaire are summarized for each device. Task relevant metrics are extracted from the raw sensor data such as gait speed, speech metrics (including periodicity, loudness, and pitch), and sit to stand transition time during sADLs. Intra-class correlation coefficient and Bland-Altman plots are used to assess agreement between metrics derived from different devices.

Conclusions: It is feasible to compare data streams from multiple sensor modalities while performing tasks that are clinically relevant. The highly instrumented lab is an ideal testing space to allow for better integration and utilization of wearable sensors in clinical trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/an-observational-study-using-multimodal-wearable-sensors-and-environmental-monitors-in-healthy-volunteers-to-characterize-activities-pertaining-to-health-wellbeing-and-daily-living/