Objective: To measure how people with Parkinson’s disease (PD) feel, function, and survive, derived from continuous recordings with a wearable ankle inertial device in a real-world setting.

Background: Previous controlled environment studies described characteristic PD walking behavior and gait disability over short periods. However, there is still a need to quantify these symptoms in the real world. Wearable inertial devices have been used for continuous gait assessment in patients with neurological conditions [1].

Method: Two clinical trials with PD patients and controls were conducted using continuous home recording after clinical assessment with the motor evaluation rating section of the Movement Disorder Society Unified Parkinson Disease Rating Scale (UPDRS-III) and the 6-minute walk test (6MWT). Subjects enrolled in the prospective, monocentric, observational DigiMarche Neuro study, wore 2 ankle devices to record data at home for 4 weeks. The multicenter, observational Pre-Quantipark study was conducted in 2016: subjects wore the same devices on their wrist and ankle for 2 weeks.

Gait variables, including the top ambulatory speed (SV95C), and the top distance covered (WD90C), were calculated from the reconstructed trajectory based on raw inertial data [2]. Their reliability was assessed using the intra-class correlation coefficient (ICC) on the 2 halves of the recording period. These measures were correlated with clinical assessments.

Results: 36 patients, aged 64 +/- 11.8 years old, were enrolled together with 16 controls, aged 66.5 +/- 10.3 years old. Eighty-nine percent of recording periods (N=40/45) had more than 100 hours of data, allowing the computation of gait variables from raw inertial signal. ICC for all computed variables were above 0.9, including 0.96 and 0.97 for baseline SV95C and WD90C, respectively. SV95C correlations with UPDRS-III and 6MWT were -0.38 (p=0.057) and 0.71, respectively (p<0.01). WD90C was not significantly correlated with UPDRS-III and 6MWT.

Conclusion: These data demonstrate the feasibility of wearable devices to continuously assess PD patients’ clinical state in their home environment, which is not permitted by the UPDRS-III or the 6 MWT. Preliminary analysis identified good reliability for all tested variables, and promising correlation with 6MWT for one of them. Future work will investigate the effect of various factors (like time of day, patient age,…) on these measures.

References: 1. Final Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies.
2. VISSIERE, D.; GRELET, M. Analyse de la foulee d’un pieton en marche. WO WO2019243609A1, 2019.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/gait-digital-outcomes-exploration-from-continuous-real-world-recordings-in-parkinsons-disease/