Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- acceptability of the solution
研究概览
简要总结
The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.
详细描述
The object of the present project is to promote the prevention of disability by providing 1) a feed-back and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The device consists of a smart, removable insole. It measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. The insole transmits wireless the collected data to a storage server through a touchpad. Data will then be available for at distance consultations by users (i.e., patients or physicians). The investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. The evaluation of the prototypes will preliminary takes place at the Blagnac smart house. 10 healthy volunteers will test the device. The second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. Comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patient aged 65 or more, living at home;
- •Presenting a frailty syndrome for the second phase, and robust volunteers for the first phase;
- •Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
排除标准
- •No access to ADSL;
- •Patient's life expectancy less than 12 months;
- •Patient presenting disability with an Activity of Daily Living score < 4/6 and/or a Mini Mental State <24/30;
- •Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
研究组 & 干预措施
Control
30 frail volunteers of the control group in the second phase won't be equipped with the smart insole.
Intervention
30 frail volunteers of the intervention group in the second phase will be equipped with the smart insole for 3 months, to encourage the frail elderly person's physical activity and to monitor key parameters of frailty
干预措施: smart insole (Device)
结局指标
主要结局
acceptability of the solution
时间窗: 3 months
based on the acceptability of the solution for the user which will be assessed in the intervention group by: quantitative and qualitative indicators Quantitative indicators: 1. Proportion of hours which the subject is awake and actually wears the smart shoe insole. This information will be collected by semi-structured interview and records actimetry of the solution. 2. Spontaneous use of data consultation interface (frequency) Qualitative indicators: Semi-structures interview conducted by the laboratory AGIM of the University Joseph Fournié
次要结局
未报告次要终点