An interventional study of Comfortable walking velocity (CWV) and Slow walking velocity (SWV: CWV - 20%) in Multiple Sclerosis, sponsored by University of Erlangen-Nürnberg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by University of Erlangen-Nürnberg · Not applicable, Interventional, and Other
The study is designed to validate the accuracy of steps detected by a commercially available smartwatch in persons with multiple sclerosis. Specifically, the investigators examine whether a smartwatch can detect steps accurately during slow, comfortable and fast overground walking. The total steps counted by the smartwatch will be compared to those counted by an accelerometer commonly used in clinical studies and the actually walked steps.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is one of the most common neurological diseases in young adulthood. The main symptoms of MS are gait and mobility impairments, which also determine the severity of the disease. Currently, subjective clinical functional tests are commonly used to evaluate therapy outcomes. Due to advancing mechanization, body-worn accelerometers have been established as a potential instrument for the objective detection of mobility in clinical research. The accuracy of these devices for determining the mobility is therefore essential. However, current studies, especially in people with altered gait, show large deviations in step detection accuracy.
In the present study we want to investigate: i) whether a commercially available smartwatch (Polar M600) counts steps in persons with multiple sclerosis (pwMS) accurately and ii) whether it counts steps as accurately as an accelerometer commonly used in clinical research (ActiGraph wGT3X-BT). In addition, the accuracy of the step detection by the algorithms of the manufacturer of the two devices (Polar M600 and ActiGraph wGT3X-BT) will be compared with an own-developed algorithm.
For this purpose, 63 pwMS with low to severe functional restriction (EDSS: 0 - 6.5) will participate in this validation study. The validation protocol consists of three walking tests with different walking velocities. During these three conditions the participants will wear the Polar M600 on the wrist and the ActiGraph wGT3X-BT with a belt over the hip. In the first walking test, the subjects will complete 250 steps with comfortable walking velocity (CWV). After a sufficient break, the participants will be randomly assigned to either a fast walking velocity condition (FWV: CWV + 20%) followed by a sufficient period of rest and a slow walking velocity condition (SWV: CWV - 20%) or vice versa. Each of the walking tests with modified walking velocity also consists of 250 steps. To analyze the accuracy of step detection, the measured steps of the devices will be compared with the actually walked 250 steps.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Erlangen-Nürnberg is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Walking for 250 steps with comfortable walking velocity (CWV), slow walking velocity (SWV: CWV - 20%) and fast walking velocity (FWV: CWV + 20%) with sufficient rest between conditions.
Behavioral: Comfortable walking velocity (CWV) · Behavioral: Slow walking velocity (SWV: CWV - 20%) · Behavioral: Fast walking velocity (FWV: CWV + 20%)
Walking for 250 Steps with self-selected comfortable walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT)
Walking for 250 Steps with slow walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Slow walking consists of walking with 20% slower than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.
Walking for 250 Steps with fast walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Fast walking consists of walking with 20% faster than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.
Step detection during comfortable walking
Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during comfortable walking for 250 steps.
Time frame: Following the comfortable walking velocity protocol, an average of 2 minutes
Step detection during slow walking
Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during slow walking for 250 steps.
Time frame: Following the slow walking velocity protocol, an average of 2 minutes
Step detection during fast walking
Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during fast walking for 250 steps.
Time frame: Following the fast walking velocity protocol, an average of 2 minutes
Plan to share: Undecided
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University of Erlangen-Nürnberg