MyoSense- Automated Muscle Hypertonicity Classification System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Correlation between clinician and device measured abnormal tone type.
研究概览
简要总结
It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
- •Over the age of five.
排除标准
- •Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
- •Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
- •Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
- •Under the age of five.
结局指标
主要结局
Correlation between clinician and device measured abnormal tone type.
时间窗: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.
Device measurements of clinician applied force relative to limb manipulation speed will be compared to conventional clinical outcome measures. For example, correlation between the slope of the force to speed profile and clinician evaluated spasticity, Ashworth score, will be calculated.
次要结局
未报告次要终点