Upper limb movements as digital biomarkers in people with ALS.

BACKGROUND: Objective evaluation of people with amyotrophic lateral sclerosis (PALS) in free-living settings is challenging. The introduction of portable digital devices, such as wearables and smartphones, may improve quantifying disease progression and hasten therapeutic development. However, there is a need for tools to characterize upper limb movements in neurologic disease and disability. METHODS: Twenty PALS wore a wearable accelerometer, ActiGraph Insight Watch, on their wrist for six months. They also used Beiwe, a smartphone application that collected self-entry ALS Functional Rating Scale-Revised (ALSFRS-RSE) survey responses every 1-4 weeks. We developed several measures that quantify count and duration of upper limb movements: flexion, extension, supination, and pronation. New measures were compared against ALSFRS-RSE total score (Q1-12), and individual responses to specific questions related to handwriting (Q4), cutting food (Q5), dressing and performing hygiene (Q6), and turning in bed and adjusting bed clothes (Q7). Additional analysis considered adjusting for total activity counts (TAC). FINDINGS: At baseline, PALS with higher Q1-12 performed more upper limb movements, and these movements were faster compared to individuals with more advanced disease. Most upper limb movement metrics had statistically significant change over time, indicating declining function either by decreasing count metrics or by increasing duration metric. All count and duration metrics were significantly associated with Q1-12, flexion and extension counts were significantly associated with Q6 and Q7, supination and pronation counts were also associated with Q4. All duration metrics were associated with Q6 and Q7. All duration metrics retained their statistical significance after adjusting for TAC. INTERPRETATION: Wearable accelerometer data can be used to generate digital biomarkers on upper limb movements and facilitate patient monitoring in free-living environments. The presented method offers interpretable monitoring of patients' functioning and versatile tracking of disease progression in the limb of interest. FUNDING: Mitsubishi-Tanabe Pharma Holdings America, Inc.

Open-Source, Step-Counting Algorithm for Smartphone Data Collected in Clinical and Nonclinical Settings: Algorithm Development and Validation Study.

BACKGROUND: Step counts are increasingly used in public health and clinical research to assess well-being, lifestyle, and health status. However, estimating step counts using commercial activity trackers has several limitations, including a lack of reproducibility, generalizability, and scalability. Smartphones are a potentially promising alternative, but their step-counting algorithms require robust validation that accounts for temporal sensor body location, individual gait characteristics, and heterogeneous health states. OBJECTIVE: Our goal was to evaluate an open-source, step-counting method for smartphones under various measurement conditions against step counts estimated from data collected simultaneously from different body locations ("cross-body" validation), manually ascertained ground truth ("visually assessed" validation), and step counts from a commercial activity tracker (Fitbit Charge 2) in patients with advanced cancer ("commercial wearable" validation). METHODS: We used 8 independent data sets collected in controlled, semicontrolled, and free-living environments with different devices (primarily Android smartphones and wearable accelerometers) carried at typical body locations. A total of 5 data sets (n=103) were used for cross-body validation, 2 data sets (n=107) for visually assessed validation, and 1 data set (n=45) was used for commercial wearable validation. In each scenario, step counts were estimated using a previously published step-counting method for smartphones that uses raw subsecond-level accelerometer data. We calculated the mean bias and limits of agreement (LoA) between step count estimates and validation criteria using Bland-Altman analysis. RESULTS: In the cross-body validation data sets, participants performed 751.7 (SD 581.2) steps, and the mean bias was -7.2 (LoA -47.6, 33.3) steps, or -0.5%. In the visually assessed validation data sets, the ground truth step count was 367.4 (SD 359.4) steps, while the mean bias was -0.4 (LoA -75.2, 74.3) steps, or 0.1%. In the commercial wearable validation data set, Fitbit devices indicated mean step counts of 1931.2 (SD 2338.4), while the calculated bias was equal to -67.1 (LoA -603.8, 469.7) steps, or a difference of 3.4%. CONCLUSIONS: This study demonstrates that our open-source, step-counting method for smartphone data provides reliable step counts across sensor locations, measurement scenarios, and populations, including healthy adults and patients with cancer.

Validation of an open-source smartphone step counting algorithm in clinical and non-clinical settings.

Background: Step counts are increasingly used in public health and clinical research to assess wellbeing, lifestyle, and health status. However, estimating step counts using commercial activity trackers has several limitations, including a lack of reproducibility, generalizability, and scalability. Smartphones are a potentially promising alternative, but their step-counting algorithms require robust validation that accounts for temporal sensor body location, individual gait characteristics, and heterogeneous health states. Objective: Our goal was to evaluate an open-source step-counting method for smartphones under various measurement conditions against step counts estimated from data collected simultaneously from different body locations ("internal" validation), manually ascertained ground truth ("manual" validation), and step counts from a commercial activity tracker (Fitbit Charge 2) in patients with advanced cancer ("wearable" validation). Methods: We used eight independent datasets collected in controlled, semi-controlled, and free-living environments with different devices (primarily Android smartphones and wearable accelerometers) carried at typical body locations. Five datasets (N=103) were used for internal validation, two datasets (N=107) for manual validation, and one dataset (N=45) used for wearable validation. In each scenario, step counts were estimated using a previously published step-counting method for smartphones that uses raw sub-second level accelerometer data. We calculated mean bias and limits of agreement (LoA) between step count estimates and validation criteria using Bland-Altman analysis. Results: In the internal validation datasets, participants performed 751.7±581.2 (mean±SD) steps, and the mean bias was -7.2 steps (LoA -47.6, 33.3) or -0.5%. In the manual validation datasets, the ground truth step count was 367.4±359.4 steps while the mean bias was -0.4 steps (LoA -75.2, 74.3) or 0.1 %. In the wearable validation dataset, Fitbit devices indicated mean step counts of 1931.2±2338.4, while the calculated bias was equal to -67.1 steps (LoA -603.8, 469.7) or a difference of 0.3 %. Conclusions: This study demonstrates that our open-source step counting method for smartphone data provides reliable step counts across sensor locations, measurement scenarios, and populations, including healthy adults and patients with cancer.

Wearable device and smartphone data quantify ALS progression and may provide novel outcome measures.

Amyotrophic lateral sclerosis (ALS) therapeutic development has largely relied on staff-administered functional rating scales to determine treatment efficacy. We sought to determine if mobile applications (apps) and wearable devices can be used to quantify ALS disease progression through active (surveys) and passive (sensors) data collection. Forty ambulatory adults with ALS were followed for 6-months. The Beiwe app was used to administer the self-entry ALS functional rating scale-revised (ALSFRS-RSE) and the Rasch Overall ALS Disability Scale (ROADS) surveys every 2-4 weeks. Each participant used a wrist-worn activity monitor (ActiGraph Insight Watch) or an ankle-worn activity monitor (Modus StepWatch) continuously. Wearable device wear and app survey compliance were adequate. ALSFRS-R highly correlated with ALSFRS-RSE. Several wearable data daily physical activity measures demonstrated statistically significant change over time and associations with ALSFRS-RSE and ROADS. Active and passive digital data collection hold promise for novel ALS trial outcome measure development.

A "one-size-fits-most" walking recognition method for smartphones, smartwatches, and wearable accelerometers.

The ubiquity of personal digital devices offers unprecedented opportunities to study human behavior. Current state-of-the-art methods quantify physical activity using "activity counts," a measure which overlooks specific types of physical activities. We propose a walking recognition method for sub-second tri-axial accelerometer data, in which activity classification is based on the inherent features of walking: intensity, periodicity, and duration. We validate our method against 20 publicly available, annotated datasets on walking activity data collected at various body locations (thigh, waist, chest, arm, wrist). We demonstrate that our method can estimate walking periods with high sensitivity and specificity: average sensitivity ranged between 0.92 and 0.97 across various body locations, and average specificity for common daily activities was typically above 0.95. We also assess the method's algorithmic fairness to demographic and anthropometric variables and measurement contexts (body location, environment). Finally, we release our method as open-source software in Python and MATLAB.

Combining digital pill and smartphone data to quantify medication adherence in an observational psychiatric pilot study.

Digital medicine systems (DMSs) offer a potential solution to increase medication adherence, which is an important barrier to treatment of psychiatric disorders. In this pilot, we enrolled N = 24 individuals diagnosed with severe mental illness to use an FDA-approved DMS for 5 months. We also collected digital phenotyping smartphone data to study behavioral associations with medication adherence. Our results suggest it is feasible to use the system, and we identified longitudinal associations between adherence and some of the communication-based phenotyping features. Larger studies and a focus on data quality are important next steps for this work.

CARL: a running recognition algorithm for free-living accelerometer data.

Wearable accelerometers hold great promise for physical activity epidemiology and sports biomechanics. However, identifying and extracting data from specific physical activities, such as running, remains challenging.Objective. To develop and validate an algorithm to identify bouts of running in raw, free-living accelerometer data from devices worn at the wrist or torso (waist, hip, chest).Approach. The CARL (continuous amplitude running logistic) classifier identifies acceleration data with amplitude and frequency characteristics consistent with running. The CARL classifier was trained on data from 31 adults wearing accelerometers on the waist and wrist, then validated on free-living data from 30 new, unseen subjects plus 166 subjects from previously-published datasets using different devices, wear locations, and sample frequencies.Main results. On free-living data, the CARL classifier achieved mean accuracy (F1score) of 0.984 (95% confidence interval 0.962-0.996) for data from the waist and 0.994 (95% CI 0.991-0.996) for data from the wrist. In previously-published datasets, the CARL classifier identified running with mean accuracy (F1score) of 0.861 (95% CI 0.836-0.884) for data from the chest, 0.911 (95% CI 0.884-0.937) for data from the hip, 0.916 (95% CI 0.877-0.948) for data from the waist, and 0.870 (95% CI 0.834-0.903) for data from the wrist. Misclassification primarily occurred during activities with similar torso acceleration profiles to running, such as rope jumping and elliptical machine use.Significance. The CARL classifier can accurately identify bouts of running as short as three seconds in free-living accelerometry data. An open-source implementation of the CARL classifier is available atgithub.com/johnjdavisiv/carl.

A systematic review of smartphone-based human activity recognition methods for health research.

Smartphones are now nearly ubiquitous; their numerous built-in sensors enable continuous measurement of activities of daily living, making them especially well-suited for health research. Researchers have proposed various human activity recognition (HAR) systems aimed at translating measurements from smartphones into various types of physical activity. In this review, we summarized the existing approaches to smartphone-based HAR. For this purpose, we systematically searched Scopus, PubMed, and Web of Science for peer-reviewed articles published up to December 2020 on the use of smartphones for HAR. We extracted information on smartphone body location, sensors, and physical activity types studied and the data transformation techniques and classification schemes used for activity recognition. Consequently, we identified 108 articles and described the various approaches used for data acquisition, data preprocessing, feature extraction, and activity classification, identifying the most common practices, and their alternatives. We conclude that smartphones are well-suited for HAR research in the health sciences. For population-level impact, future studies should focus on improving the quality of collected data, address missing data, incorporate more diverse participants and activities, relax requirements about phone placement, provide more complete documentation on study participants, and share the source code of the implemented methods and algorithms.

Accelerometry data in health research: challenges and opportunities.

Wearable accelerometers provide detailed, objective, and continuous measurements of physical activity (PA). Recent advances in technology and the decreasing cost of wearable devices led to an explosion in the popularity of wearable technology in health research. An ever-increasing number of studies collect high-throughput, sub-second level raw acceleration data. In this paper, we discuss problems related to the collection and analysis of raw accelerometry data and refer to published solutions. In particular, we describe the size and complexity of the data, the within- and between-subject variability, and the effects of sensor location on the body. We also discuss challenges related to sampling frequency, device calibration, data labeling and multiple PA monitors synchronization. We illustrate these points using the Developmental Epidemiological Cohort Study (DECOS), which collected raw accelerometry data on individuals both in a controlled and the free-living environment.

On Placement, Location and Orientation of Wrist-Worn Tri-Axial Accelerometers during Free-Living Measurements.

Wearable accelerometers have recently become a standalone tool for the objective assessment of physical activity (PA). In free-living studies, accelerometers are placed by protocol on a pre-defined body location (e.g., non-dominant wrist). However, the protocol is not always followed, e.g., the sensor can be moved between wrists or reattached in a different orientation. Such protocol violations often result in PA miscalculation. We propose an approach, PLOE ("Placement, Location and Orientation Evaluation method"), to determine the sensor position using statistical features from the raw accelerometer measurements. We compare the estimated position with the study protocol and identify discrepancies. We apply PLOE to the measurements collected from 45 older adults who wore ActiGraph GT3X+ accelerometers on the left and right wrist for seven days. We found that 15.6% of participants who wore accelerometers violated the protocol for one or more days. The sensors were worn on the wrong hand during 6.9% of the days of simultaneous wearing of devices. During the periods of discrepancies, the daily PA was miscalculated by more than 20%. Our findings show that correct placement of the device has a significant effect on the PA estimates. These results demonstrate a need for the evaluation of sensor position.