NCT00592826已完成不适用
Phase III Study of the Usability of the HMP Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Proportion of subjects who successfully set up the device
研究概览
简要总结
The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .
详细描述
Stage I:
- Receive a packed HMP device.
- Unpack the device and install it, using a set-up guide
- Use an interactive tutorial to learn the task
- Calibrate the sensitivity of the test
This stage will be completed within 1 to 5 visits, depending on personal progress rate.
Subjects who have successfully completed stage I will be recruited to stage II.
Those subjects will:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >50 years
- •Familiar with computer usage
- •Capable and willing to sign a consent form and participate in the study
- •Ability to speak, read and understand instructions in English
排除标准
- •Subject already participating in another study.
结局指标
主要结局
Proportion of subjects who successfully set up the device
时间窗: 1 month
Proportion of subjects who successfully pass the training program (successful calibration module)
时间窗: 1 month
次要结局
- Proportion of subjects with reliable tests results(1 month)
研究者
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