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Background Gait impairments are among the most common and impactful symptoms of Parkinson’s disease (PD). Recent technological advances aim to quantify these impairments using low-cost wearable systems for use in either supervised clinical consultations or long-term unsupervised monitoring of gait in ecological environments. However, very few of these wearable systems have been validated comparatively to a criterion of established validity. Objective We developed two movement analysis solutions (3D full-body kinematics based on inertial sensors, and a smartphone application) in which validity was assessed versus the optoelectronic criterion in a population of PD patients. Methods Nineteen subjects with PD (7 female) participated in the study (age: 62 ± 12.27 years; disease duration: 6.39 ± 3.70 years; HY: 2 ± 0.23). Each participant underwent a gait analysis whilst barefoot, at a self-selected speed, for a distance of 3 times 10 m in a straight line, assessed simultaneously with all three systems. Results Our results show excellent agreement between either solution and the optoelectronic criterion. Both systems differentiate between PD patients and healthy controls, and between PD patients in ON or OFF medication states (normal difference distributions pooled from published research in PD patients in ON and OFF states that included an age-matched healthy control group). Fair to high waveform similarity and mean absolute errors below the mean relative orientation accuracy of the equipment were found when comparing the angular kinematics between the full-body inertial sensor-based system and the optoelectronic criterion. Conclusions We conclude that the presented solutions produce accurate results and can capture clinically relevant parameters using commodity wearable sensors or a simple smartphone. This validation will hopefully enable the adoption of these systems for supervised and unsupervised gait analysis in clinical practice and clinical trials.

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Mobile health (mHealth) has emerged as a potential solution to providing valuable ecological information about the severity and burden of Parkinson’s disease (PD) symptoms in real-life conditions. Objective: The objective of our study was to explore the feasibility and usability of an mHealth system for continuous and objective real-life measures of patients’ health and functional mobility, in unsupervised settings. Methods: Patients with a clinical diagnosis of PD, who were able to walk unassisted, and had an Android smartphone were included. Patients were asked to answer a daily survey, to perform three weekly active tests, and to perform a monthly in-person clinical assessment. Feasibility and usability were explored as primary and secondary outcomes. An exploratory analysis was performed to investigate the correlation between data from the mKinetikos app and clinical assessments. Results: Seventeen participants (85%) completed the study. Sixteen participants (94.1%) showed a medium-to-high level of compliance with the mKinetikos system. A 6-point drop in the total score of the Post-Study System Usability Questionnaire was observed. Conclusions: Our results support the feasibility of the mKinetikos system for continuous and objective real-life measures of a patient’s health and functional mobility. The observed correlations of mKinetikos metrics with clinical data seem to suggest that this mHealth solution is a promising tool to support clinical decisions.

Introduction:The satisfactory symptomatic control of the axial symptoms of Parkinson's disease (PD) remains challenging. As these symptoms are an important cause of disability, new therapeutic strategies should be developed and evaluated. To do this, it is necessary to select the outcomes to be measured and reported in a clinical trial. In this study, we sought to identify the most responsive outcome measures for assessing the efficacy of a multidisciplinary intervention on the axial symptoms of PD.Methods: An exploratory prospective clinical study was conducted. PD patients engaged in a pre-defined multidisciplinary intervention program for parkinsonian patients were assessed at admission and discharge by a multidisciplinary team. The responsiveness to intervention was evaluated and the smallest sample size needed to enable statistically significant results for an expected 30% change from baseline for each outcome was calculated.Results: Twenty-two patients were included in the study. The effect size detected varied between 0.04 and 0.83. The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score and each subsection, the N-FOG questionnaire, the 10-m walk test, and Frenchay Dysarthria Assessment-2 Edition (FDA-2) showed a medium to large effect size. Sample size calculations for 90% power and assuming 30% change from baseline ranged from eight to 180 participants. The outcome measures that require a small number of participants to enable statistically significant results were the FDA-2 rating scale (n = 4 participants), the MDS-UPDRS total score (n = 9), the 10-m walk test (n = 9), and the MDS-UPDRS motor examination (n = 10). Conclusions:The MDS-UPDRS part III and total score and the 10-m walk test were the outcomes with the best responsiveness to a multidisciplinary intervention and required a small number of participants to enable statistically significant results. Further studies are needed to clarify the suitability of the Timed Up and Go test.