Real-World Evidence for a Smartwatch-Based Parkinson’s Motor Assessment App for Patients Undergoing Therapy Changes

Abstract

<b><i>Introduction:</i></b> Parkinson’s disease (PD) is poorly quantified by patients outside the clinic, and paper diaries have problems with subjective descriptions and bias. Wearable sensor platforms; however, can accurately quantify symptoms such as tremor, dyskinesia, and bradykinesia. Commercially available smartwatches are equipped with accelerometers and gyroscopes that can measure motion for objective evaluation. We sought to evaluate the clinical utility of a prescription smartwatch-based monitoring system for PD utilizing periodic task-based motor assessment. <b><i>Methods:</i></b> Sixteen patients with PD used a smartphone- and smartwatch-based monitoring system to objectively assess motor symptoms for 1 week prior to instituting a doctor recommended change in therapy and for 4 weeks after the change. After 5 weeks the participants returned to the clinic to discuss their results with their doctor, who made therapy recommendations based on the reports and his clinical judgment. Symptom scores were synchronized with the medication diary and the temporal effects of therapy on weekly and hourly timescales were calculated. <b><i>Results:</i></b> Thirteen participants successfully completed the study and averaged 4.9 assessments per day for 3 days per week during the study. The doctor instructed 8 participants to continue their new regimens and 5 to revert to their previous regimens. The smartwatch-based assessments successfully captured intraday fluctuations and short- and long-term responses to therapies, including detecting significant improvements (<i>p</i> < 0.05) in at least one symptom in 7 participants. <b><i>Conclusions:</i></b> The smartwatch-based app successfully captured temporal trends in symptom scores following application of new therapy on hourly, daily, and weekly timescales. These results suggest that validated smartwatch-based PD monitoring can provide clinically relevant information and may reduce the need for traditional office visits for therapy adjustment.

“suMus,” a novel digital system for arm movement metrics and muscle energy expenditure

“…Further, the smartwatch-technology is a proved relevant source of objective motility monitoring, allowing great precision in recording subtle changes in any patients’ home environment. In large cohorts of patients affected by Parkinson’s disease, smartwatch accelerometer data could quantify low hand-tremor amplitudes and frequencies with high accuracy ( Hadley et al, 2021 ; Powers et al, 2021 ).…”

A Holter for Parkinson's Disease Motor Symptoms: STAT-ONTM

“…Finally, the STAT-ON™ could be used as a helpful tool not only in double-blinded clinical trials but also in phase IV studies providing information about clinical real-world evidence. Data about real-world evidence is of great importance after starting with the commercialization of a novel molecule and the use of wearable sensor platforms, smartwatches equipped with accelerometers and other wearable devices could be used for getting very important information [45,[48][49][50][51][52][53].…”

Parkinson's Disease and Wearable Technology

“…Therefore, remote wearable devices along with smartphone applications have been used in several studies to monitor ON/OFF fluctuations[ 41 ] along with tremors and bradykinesia. [ 42 ] The data collected from these devices are vital for physicians to understand disease progression and symptom triggers. They use this information to titrate the patient's medication based on empirical data.…”