Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- FeetMe
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.
研究概览
简要总结
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.
Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.
At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).
The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects aged 60 years and above
- •with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)
- •a fall within the last year, who own a smartphone.
排除标准
- •cognitive deficit or concomitant disorder limiting communication or participation in the study
- •simultaneous participation in another study
- •deprivation of liberty due to a legal or administrative decision
- •patients receiving psychiatric care
- •adults beyond the age of majority under legal protection measures or unable to express their consent
- •patients admitted to a health or social establishment for reasons other than research.
结局指标
主要结局
To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.
时间窗: at baseline
Assess walking speed decrease during 6MWT at baseline
次要结局
未报告次要终点