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.
Highlights
The progressive and debilitating nature of amyotrophic lateral sclerosis (ALS) restricts patients from participating in clinical trials
We show the feasibility and value of remote, accelerometer-based monitoring of disease progression in patients with ALS
King's ALS Stage sample sizes, and by providing patients with the opportunity to participate in clinical trials from home
Summary
The progressive and debilitating nature of amyotrophic lateral sclerosis (ALS) restricts patients from participating in clinical trials. Giving patients the opportunity to participate in clinical trials from home is intriguing, especially for debilitating disorders such as ALS. We determine the value of remote, accelerometer-based monitoring of physical activity in patients with ALS. We defined four accelerometer-based endpoints that either reflect the average daily activity or quantify the patient’s physical capacity. Conclusion Accelerometry 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. Remote monitoring provides patients with the opportunity to participate in clinical trials from home, paving the way to a patient-centric clinical trial model
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