Validation of Gait Metrics From Cionic Neural Sleeve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cionic, Inc.
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Cadence
研究概览
简要总结
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway. The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the "gold standard" ground truth measurements in the proposed protocol. Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time. Findings of inaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution and/or updated to provide correct outcomes to users.
详细描述
The study aims to validate the gait metrics of the Neural Sleeve in healthy adult volunteers. All participants will wear a Neural Sleeve on their dominant leg. The Zeno pressure gait mat will be laid flat on the ground and used for all four walking conditions. Participants will perform two 5-minute walking bouts at each of the four speed conditions while wearing the Cionic Neural Sleeve without electrical stimulation. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Neural Sleeve to those measured by the gait mat. During the walking trials, participants will be told that they can take a break if needed. Condition order will be randomized and participants will be offered 5 minutes of rest between consecutive trials. Validity of gait metrics of the Neural Sleeve will be compared against the Zeno walkway.
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
- 22 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons between the ages of 22-64
- •Ability to ambulate at least 30 minutes during a two-hour period
排除标准
- •Lower motor neuron disease or injury (e.g. peripheral neuropathy)
- •Absent sensation in the legs
- •Demand-type cardiac pacemaker or defibrillator
- •Malignant tumor in the legs
- •Existing thrombosis in the legs
- •History of lower limb injury or orthopedic issues leading to impaired walking
结局指标
主要结局
Cadence
时间窗: A walking session of up to 5 minutes
Number of steps per minute (steps per minute)
Gait speed
时间窗: A walking session of up to 5 minutes
Time one takes to walk a specified distance (expressed as a ratio between distance and time, in centimeters per second)
Stride length
时间窗: A walking session of up to 5 minutes
Distance (centimeters) covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel) (centimeters)
次要结局
未报告次要终点