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临床试验/NCT04324333
NCT04324333招募中不适用

Modelling Missteps to Improve Fall Risk Assessment.

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Physical Activity

研究概览

简要总结

The long-term goals of the project are: 1) Preventing falls before they occur, by significantly improving our ability to monitor fall risk and develop early and sensitive markers for this risk, based on tripping and near falls and other physiological signs, 2) automatically diagnosing falls within seconds from the time of the incident, without the need for an emergency / distress button or making a phone call.

详细描述

All subjects will be asked to come to the Center for the Study of Movement, Cognition and Mobility (CMCM), where they will undergo baseline testing. This initial evaluation is designed 1) to assess each subject's mobility, fall risk and related functions, and 2) to obtain more specific information that will be used to inform and update the model of falls and missteps detection.

The study is divided into 3 sections:

  1. First session in Gait Lab (CMCM) for an overall assessment of subject health (see below).
  2. Using the system ("monitoring ADL period") in daily life for 4 months (system: Owlytics Healthcare's app+wearable wristband & insoles).
  3. A concluding session where the mobility tests performed at the beginning of the study are repeated to assess the changes that occurred during the a period in which the monitoring system is used.

During the first session medical data will be recorded, such as demographics (age, gender, years of education, etc.), habits (physical activity, leisure activities, dietary habits), daily life activities, health-related behaviors (e.g., alcohol consumption and smoking history) and so.

Medical examination will include standardized walking tests (usual-walking and dual-task walking), eye examination, hearing test, balance tests, etc. In addition, to assess cognitive abilities standard Neuropsychological Battery will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Physical Activity

时间窗: One week post monitoring period

The International Physical Activity Questionnaires (IPAQ-short). It will quantify the health-related physical activity.

Community ambulation

时间窗: One week post monitoring period

A body-worn small lightweight device (6-Axis Logging Accelerometer) that will be worn by the subject for 7 days to monitor ADL.

The frequency of falling

时间窗: One week post monitoring period

The subjects are asked to fill in monthly Fall log (Frequency and circumstances of falls if occurred)

次要结局

  • Improve in motor function(One week post monitoring period)
  • Changes in endurance(One week post monitoring period)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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