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临床试验/NCT03750097
NCT03750097已完成不适用

Validation of a Commercially Available Smartwatch for Step Detection in Persons With Multiple Sclerosis

University of Erlangen-Nürnberg2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Step detection during comfortable walking

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Multiple Sclerosis with Expanded Disability Status Scale between 0 - 6.5
  • Ability to walk 250 steps with or without an assistive device

排除标准

  • Clinically relevant cardiovascular or orthopaedic disease
  • Severe polyneuropathy
  • Cognitive impairment

研究组 & 干预措施

Walking protocol

Experimental

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.

干预措施: Comfortable walking velocity (CWV) (Behavioral)

Walking protocol

Experimental

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.

干预措施: Slow walking velocity (SWV: CWV - 20%) (Behavioral)

Walking protocol

Experimental

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.

干预措施: Fast walking velocity (FWV: CWV + 20%) (Behavioral)

结局指标

主要结局

Step detection during comfortable walking

时间窗: Following the comfortable walking velocity protocol, an average of 2 minutes

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.

次要结局

  • Step detection during slow walking(Following the slow walking velocity protocol, an average of 2 minutes)
  • Step detection during fast walking(Following the fast walking velocity protocol, an average of 2 minutes)

研究者

发起方
University of Erlangen-Nürnberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Klaus Pfeifer

Prof. Dr.

University of Erlangen-Nürnberg

研究点 (2)

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