Accelerometry for remote monitoring of physical activity in amyotrophic lateral sclerosis: a longitudinal cohort study

Abstract

BackgroundThe extensive heterogeneity between patients with amyotrophic lateral sclerosis (ALS) complicates the quantification of disease progression. In this study, we determine the value of remote, accelerometer-based monitoring of physical activity in patients with ALS.MethodsThis longitudinal cohort study was conducted in a home-based setting; all study materials were sent by mail. Patients wore the ActiGraph during waking hours for 7 days every 2–3 months and provided information regarding their daily functioning (ALSFRS-R). We defined four accelerometer-based endpoints that either reflect the average daily activity or quantify the patient’s physical capacity.ResultsA total of 42 patients participated; the total valid monitoring period was 9288 h with a 93.0% adherence rate. At baseline, patients were active 27.9% (range 11.6–52.4%) of their time; this declined by 0.64% (95% 0.43–0.86, p < 0.001) per month. Accelerometer-based endpoints were strongly associated with the ALSFRS-R (r 0.78, 95% CI 0.63–0.92, p < 0.001), but showed less variability over time than the ALSFRS-R (coefficient of variation 0.64–0.81 vs. 1.06, respectively). Accelerometer-based endpoints could reduce sample size by 30.3% for 12-month trials and 44.6% for 18-month trials; for trials lasting less than 9 months, the ALSFRS-R resulted in smaller sample sizes.ConclusionAccelerometry is an objective method for quantifying disease progression, which could obtain real-world insights in the patient’s physical functioning and may personalize the delivery of care. In addition, remote monitoring provides patients with the opportunity to participate in clinical trials from home, paving the way to a patient-centric clinical trial model.

New technologies and Amyotrophic Lateral Sclerosis – Which step forward rushed by the COVID-19 pandemic?

“…Controlling physical activity overtime in ALS is feasible by the remote use of accelerometers, showing good compliance (93%), with results strongly correlated with ALSFRS-R, and low variability [45]. It has also been successfully assessed at-home through accelerometers and an ECG sensor in addition to in-hospital evaluations every 3-months, also including speech recording in the latter setting [46].…”

Data Collection in Multiple Sclerosis: The MSDS Approach

“…PROs are collected using standardized questionnaires and provide valuable information on the effectiveness of interventions and therapies (20,(38)(39)(40)(41). The patients' symptoms and physical impairments remain unexplored by the healthcare providers, especially in the intervals between clinic visits (42)(43)(44)(45). In addition, pwMS are often affected by varying degrees of cognitive impairment and may forget what they felt a week or two before planned visits (46)(47)(48).…”

TRICALS: creating a highway toward a cure

“…In order to improve the translational power of exploratory to confirmatory trials, the follow-up duration of exploratory trials should be increased to at least 6 months and indicate a response in biomarkers of target engagement, or in multiple clinical endpoints, prior to initiation of a confirmatory trial. As showing a therapeutic benefit on mortality is required by European regulators for market authorization (25), the follow-up duration of confirmatory trials should be increased to at least 12 months in order to design trials with feasible sample sizes (27). Halting or slowing motor neuron degeneration may be slow, and take time to manifest in trial endpoints.…”

“…The power to quantify a survival benefit can be improved by employing the Joint Modeling Framework (14). In addition, remote digital technology can help to further define the real-world functional benefits of a therapeutic intervention (13,27,28), whereas extensive training on outcome measures as organized by TRICALS and Northeast ALS Consortium (NEALS) may warrant quality control and minimize endpoint variability (5,15).…”