Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Average sit-to-stand transition time over 48-hour monitoring period
研究概览
简要总结
BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a single wearable motion sensor that is worn on the torso. The objectives of this observational study are the following: 1) to test the efficacy of PAMSys for objectively assessing a persons risk of falling based on activity data measured during activities of daily living and 2) to test the efficacy of PAMSys for identifying precise early physical activity or functioning indicators of frailty in those who are pre-frail or frail as compared to non-frail controls.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling ambulatory men or women ages 65 and above
排除标准
- •Mental Status Mini Exam score < 23
- •Those who are unwilling or unable to comprehend informed consent
结局指标
主要结局
Average sit-to-stand transition time over 48-hour monitoring period
时间窗: Averaged over days 1 and 2
Eligible subjects will receive a PAMSys motion sensors and necessary instructions for proper use. They will then wear the motion sensor continuously for 48 hours. PAMSys will record the duration of each sit-to-stand transition during this 48 hour monitoring period. The primary outcome measure is the average of these durations.
次要结局
- Average stand-to-sit transition time during 48 hours of continuous monitoring(Averaged over days 1 and 2)