Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
研究概览
简要总结
The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.
详细描述
The study has two main objectives, conducted together. Each objective include several phases.
Objective 1: technical validation of GPS measurements in healthy subjects.
phase 1: technical validation of a GPS device to study outdoor walking (completed).
phase 2: comparison and use of various GPS devices (intra- and inter-GPS variability) in the study outdoor walking (on-going).
phase 3: study of several factors that could influence accuracy of GPS measurements as walking speed, environment, sampling frequency and others technical features as the WAAS/EGNOS function (on-going).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ankle to Brachial Index (ABI) < 0.95 for PAD patients
- •Age > 18 years old
- •Able to walk on treadmill
排除标准
- •limb pain of potential non-vascular origin
- •myocardial infraction in the last six months
- •uncontrolled angina pectoris
结局指标
主要结局
Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
时间窗: 2 years
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
时间窗: 2 years
次要结局
- Determine the variability of the walking capacity and its potential determinants in PAD patients.(3 years)
- Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.(4 years)
- Analyse potential factors that could affect the accuracy of GPS measurements(4 years)