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临床试验/NCT05898555
NCT05898555招募中不适用

Validation of Smart Garments for Gait and Balance Assessment

Myant Medical Corp.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Error in terminal double support (s) metric, and its asymmetry

研究概览

简要总结

The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.

详细描述

Specific objectives of this study are:

  1. To validate Skiin gait characterization algorithm (based on single garment solutions - already developed based on a literature and a previous study conducted at the University of Waterloo);
  2. To develop algorithms for multi-garments solutions that aim to extract additional kinematic parameters such as joint angles.

Gait metrics from Skiin garments will be compared to metrics from a gold standard measurement (Vicon motion capture) to indicate accuracy, precision and reliability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female adults aged 18y - 64y old

排除标准

  • Self-reported lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise.

结局指标

主要结局

Error in terminal double support (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between terminal double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in mean CoM sway velocity

时间窗: Collection during the single study session of 1.5 hours.

The difference between sway velocity of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.

Error in single limb support (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between single limb support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in step length metric

时间窗: Collection during the single study session of 1.5 hours.

The difference between step lengths calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in stance duration (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between stance duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in initial double support (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in stride speed metric

时间窗: Collection during the single study session of 1.5 hours.

The difference between stride speed calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in double support (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in mean CoM sway distance

时间窗: Collection during the single study session of 1.5 hours.

The difference between sway distance of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.

Error in CoM sway area

时间窗: Collection during the single study session of 1.5 hours.

The difference between sway area of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.

Error in CoM sway frequency

时间窗: Collection during the single study session of 1.5 hours.

The difference between sway frequency of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.

Error in stride length metric

时间窗: Collection during the single study session of 1.5 hours.

The difference between stride length calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in cadence metric

时间窗: Collection during the single study session of 1.5 hours.

The difference between cadence calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in step duration (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between step duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in stride duration (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between stride duration (s), and its asymmetry calculated from Skiin data for each scripted gait tasks.

Error in swing duration (s) metric, and its asymmetry

时间窗: Collection during the single study session of 1.5 hours.

The difference between swing duration(s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.

Error in gait speed metric

时间窗: Collection during the single study session of 1.5 hours.

The difference between gait speed calculated from Skiin data and from Vicon data for each scripted gait tasks.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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