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临床试验/NCT00767429
NCT00767429Unknown不适用

Development of an Acceleration Based Fall Risk Detector

Maastricht University Medical Center8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
8
主要终点
Acceleration based movement characteristics

研究概览

简要总结

Because the increasing fall problem, mainly due to an impaired gait and balance ability, this study will investigate fall risk by detecting fall related movement characteristics. Based on the promising results using accelerometry for accurate and objective gait analysis, fall risk will be measured using a triaxial accelerometer.

At the moment our group is performing a study titled 'identify subjects at risk for falling using accelerometry'. In this study, fall related movement characteristics (gait, balance, stumble reaction) are identified in healthy younger and older subjects under standardised laboratory circumstances. In this way, specific characteristics can be selected which are responsible for fall risk.

The aim of this study is investigating if the acceleration based fall risk detector can be applied in daily life with target groups.

详细描述

A first step to field measurement with target group is the measurement of elderly with a certain fall risk in a simple field condition like a nursing home.

First fall risk is assessed in elderly using the Tinetti scale (score between 19-24) which is the gold standard for fall risk assessment . This scale consist of a gait and balance score. Only subjects who have a fall risk are included for further measurements.

  1. A gait test will be performed to analyze movement parameters. Subjects have to walk 6 times a 20 meter distance at preferred speed while a small (56mmx61mmx15mm), light weight (5g) and ambulant accelerometer is attached on the sacrum with an elastic belt. The accelerometer measures accelerations of the body in three directions (antero-posterior, media-lateral and cranial-caudal) with a sample frequency of 100Hz.
  2. The balance ability will be tested by performing 4 balance tasks while the same accelerometer measures the movements of the body. Subjects have to stand with feet closed on a normal or foam surface while having the eyes open and closed.
  3. The Get Up and Go test is performed: subjects start in sitting position, have to rise, walk 3m, turn around, walk back and sit again. The time needed to perform this test is measured.
  4. 20 subjects (remaining in Scharweyerveld and Zorgboog) are monitored for one day and 20 elderly women (>70y) (recruited at the F&O policlinic MUMC)are measured for 5 successive days, to investigate the mobility and more fall related movement parameters. The accelerometer is attached to the sacrum in the morning. First the other 2 measurements are performed, and then subjects wear the device during the whole day. The accelerometer is small, light and ambulant which is not interfering with daily activities. Subjects have to keep a diary to note all activities performed during that day. THis will be used to explain the acceleration signal.

For the subject recruited from the F&O poli, a fall diary is kept for one year were subjects have to note when a fall has happened. In addition muscle strength in measured in this population and a questionnaire concerning quality of life (Euroqol) is completed in this group.

All acceleration data will be analyzed using specific algorithms programmed in Matlab(c). Statistical analysis will be performed in SPSS using pearson correlation to investigate correlations between gait parameters, balance characteristics and the ability perform the Get Up and Go test. Pearson correlation will also be used to validate the objective gait and balance test with the Tinetti scale. Differences in function tests between elderly at risk (measured in this study) and healthy subjects (measured in a previous study under lab conditions) will be investigated using ANOVA (p< 0.005).

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

  • Having a fall risk (Tinetti score between 19-24)
  • Men and women older than 65 years at risk for falling - able to walk without walking aids - voluntary and willing to participate
  • Fully competent

排除标准

  • Unable to walk
  • Very high fall risk (Tinetti score < 19)

结局指标

主要结局

Acceleration based movement characteristics

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (8)

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