clinical trial endpoint
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2020 ◽  
Vol 16 (1) ◽  
pp. 11-21 ◽  
Author(s):  
Adam M. Staffaroni ◽  
Lynn Bajorek ◽  
Kaitlin B. Casaletto ◽  
Yann Cobigo ◽  
Sheng-Yang M. Goh ◽  
...  

2019 ◽  
Author(s):  
Gerhard Aigner ◽  
Bernd Grimm ◽  
Christian Lederer ◽  
Martin Daumer

Background. Physical activity (PA) is increasingly being recognized as a major factor related to the development or prevention of many diseases, as an intervention to cure or delay disease and for patient assessment in diagnostics, as a clinical outcome measure or clinical trial endpoint. Thus, wearable sensors and signal algorithms to monitor PA in the free-living environment (real-world) are becoming popular in medicine and clinical research. This is especially true for walking speed, a parameter of PA behaviour with increasing evidence to serve as a patient outcome and clinical trial endpoint in many diseases. The development and validation of sensor signal algorithms for PA classification, in particular walking, and deriving specific PA parameters, such as real world walking speed depends on the availability of large reference data sets with ground truth values. In this study a novel, reliable, scalable (high throughput), user-friendly device and method to generate such ground truth data for real world walking speed, other physical activity types and further gait-related parameters in a real-world environment is described and validated. Methods. A surveyor’s wheel was instrumented with a rotating 3D accelerometer (actibelt). A signal processing algorithm is described to derive distance and speed values. In addition, a high-resolution camera was attached via an active gimbal to video record context and detail. Validation was performed in the following main parts: 1) walking distance measurement is compared to the wheel’s built-in mechanical counter, 2) walking speed measurement is analysed on a treadmill at various speed settings, 3) speed measurement accuracy is analysed by an independent certified calibration laboratory - accreditation by DAkkS applying standardised test procedures. Results: The mean relative error for distance measurements between our method and the built-in counter was 0.12%. Comparison of the speed values algorithmically extracted from accelerometry data and true treadmill speed revealed a mean adjusted absolute error of 0.01 m/s (relative error: 0.71 %). The calibration laboratory found a mean relative error between values algorithmically extracted from accelerometry data and laboratory gold standard of 0.36% (0.17-0.64 min/max), which is below the resolution of the laboratory. An official certificate was issued. Discussion. Error values were a magnitude smaller than the any clinically important difference for walking speed. Conclusion. Besides the high accuracy, the presented method can be deployed in a real world setting and allows to be integrated into the digital data flow.


Author(s):  
Gerhard Aigner ◽  
Bernd Grimm ◽  
Christian Lederer ◽  
Martin Daumer

Background. Physical activity (PA) is increasingly being recognized as a major factor related to the development or prevention of many diseases, as an intervention to cure or delay disease and for patient assessment in diagnostics, as a clinical outcome measure or clinical trial endpoint. Thus, wearable sensors and signal algorithms to monitor PA in the free-living environment (real-world) are becoming popular in medicine and clinical research. This is especially true for walking speed, a parameter of PA behaviour with increasing evidence to serve as a patient outcome and clinical trial endpoint in many diseases. The development and validation of sensor signal algorithms for PA classification, in particular walking, and deriving specific PA parameters, such as real world walking speed depends on the availability of large reference data sets with ground truth values. In this study a novel, reliable, scalable (high throughput), user-friendly device and method to generate such ground truth data for real world walking speed, other physical activity types and further gait-related parameters in a real-world environment is described and validated. Methods. A surveyor’s wheel was instrumented with a rotating 3D accelerometer (actibelt). A signal processing algorithm is described to derive distance and speed values. In addition, a high-resolution camera was attached via an active gimbal to video record context and detail. Validation was performed in the following main parts: 1) walking distance measurement is compared to the wheel’s built-in mechanical counter, 2) walking speed measurement is analysed on a treadmill at various speed settings, 3) speed measurement accuracy is analysed by an independent certified calibration laboratory - accreditation by DAkkS applying standardised test procedures. Results: The mean relative error for distance measurements between our method and the built-in counter was 0.12%. Comparison of the speed values algorithmically extracted from accelerometry data and true treadmill speed revealed a mean adjusted absolute error of 0.01 m/s (relative error: 0.71 %). The calibration laboratory found a mean relative error between values algorithmically extracted from accelerometry data and laboratory gold standard of 0.36% (0.17-0.64 min/max), which is below the resolution of the laboratory. An official certificate was issued. Discussion. Error values were a magnitude smaller than the any clinically important difference for walking speed. Conclusion. Besides the high accuracy, the presented method can be deployed in a real world setting and allows to be integrated into the digital data flow.


2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi82-vi82
Author(s):  
Julie Miller ◽  
Franziska Loebel ◽  
Isabel Arrillaga-Romany ◽  
Daniel Mordes ◽  
Nina Lelic ◽  
...  

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