跳至主要内容
临床试验/NCT05693480
NCT05693480招募中不适用

Development and Applications of Daily-use Fall Risk Assessment Device to Prevent Elderly People From Falling

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2022年7月1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
1,300
试验地点
2
主要终点
Precision assessment of falling risk prediction

研究概览

简要总结

This research attempts to develop an artificial intelligence (AI) enabled device for measuring the dynamic balance ability of older people with a sensor using an optical principle called Frustrated Total Internal Reflection. The AI-based algorithm embedded in the device performs the data analysis for balance ability assessment and falling risk prediction. As a critical part of the research, a large-scale user study is needed to test the validity of the device regarding the dynamic balance ability assessment and the accuracy of the falling risk prediction provided by the device. Also, we plan to study the factors influencing user engagement in this device through the questionnaire-based survey and interview.

详细描述

Falling is a significant threat to the health and independent living quality of the elderly. The loss of balance leads to falls. Balance is a very complex neuromuscular reflex function that may be affected by the general condition of the body and one or more impairments in the sensory, nervous, cardiovascular, and musculoskeletal systems. Currently, no test or tool can directly measure balancing capability in the clinical setting. Most clinicians use proxy-based methods to estimate the likelihood of falling, such as the Timed Up and Go Test which has low diagnostic accuracy. Other commonly used observational fall assessment tools (e.g., Berg Balance Scale and Performance-Oriented Mobility Assessment) require long administration time, suffering ceiling effects and subjective judgment. The computerized dynamic posturography devices are used in specialized fall assessment and rehabilitation centers. However, these devices are not routinely used in clinical or home settings due to high user costs and special training requirements.

To overcome the abovementioned limitations of extant approaches for measuring dynamic balance ability and predicting the risk of falling. This research attempts to develop an artificial intelligence (AI) enabled device for measuring the dynamic balance ability of older people with a sensor using an optical principle called Frustrated Total Internal Reflection (FTIR). The AI-based algorithm embedded in the device performs the data analysis for balance ability assessment and falling risk prediction.

As a critical part of the research, a large-scale user study is needed to test the validity of the device regarding the dynamic balance ability assessment compared with the common clinical assessment tools used by doctors and other healthcare professionals. In addition, this large-scale user study will also investigate the accuracy of the falling risk prediction provided by the device. Also, the investigators plan to study the factors influencing user engagement in this device through the questionnaire-based survey.

The targeted direct user group of this device is people aged 60 years old or above who live in Hong Kong. The whole study will last six months, and the outcome will be assessed pre-and post-implementation for comparison and validation. The major testing criteria include the device specifications for validity and reliability, user experiences and adoption, prediction model accuracy.

First Round: The participant will be invited to take three tests: A device test, a time up and go test, and a Berg balance test. The device test involves five simple tasks that require participants to complete while using the balance sensor to assess the balance ability. In addition, participants will be required to complete physical data measurements to collect the weight, height, blood pressure, muscle mass, body mass index (BMI), and other physical data. Besides, participants will be required to complete questionnaires.

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
60 Years 至 80 Years(Adult, 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

Precision assessment of falling risk prediction

时间窗: Six Months

A primary outcome is the precision assessment of falling risk prediction. The specific measurement variables for this primary outcome are the classification results of high/low falling risk based on the scoring results (a composite result, namely Falling Probability (FP)) of the device test and participants' actual falling incident indicators, including the number of falls, the severity of falling incidents after the device test, and medical history of the participants (say, the falls history within past six months). The FP ranges from zero to one, in which the higher score indicates a higher possibility of fall. The analysis metric for this primary outcome is sensitivity and specificity performance analysis of the device assessment.

次要结局

  • Validity of the balance ability measurement made by the device(Six Months)
  • User Experience(Six Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Xi Ning

Chair Professor of Robotics and Automation; Director of Emerging Technologies Institute

The University of Hong Kong

研究点 (2)

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