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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05308563
Other study ID # 202112114RINA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2022
Est. completion date December 2023

Study information

Verified date March 2022
Source National Taiwan University Hospital
Contact Huey-Wen Liang
Phone +886-02-23123456
Email lianghw@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to combine a novel posturogrpahy based on HTC VIVE trackers and hybrid machine learning and deep learning algorithms to establish a set of simple, convenient and valid fall risk assessment tool. This observational and follow up study will community elderly aged over 60 years old. The investigators will collect demographic data, questionnaire surveys, traditional balance tests and the tracker-based posturography to obtain the trunk stability parameters in different standing task. The fall risk will be classified according to self-reported falls n the past one year and verified in a 6-month follow up. The investigators will evaluate the performance of different hybrid machine learning and deep learning algorithm to extract the important features of multiple posturographic parameters and select an optimal model. The investigators will use the receiver operating characteristic curve analysis to compute the sensitivity, specificity and accuracy of different algorithms for risk classification and also compare the performance with traditional balance assessment tools.


Description:

The purpose of this project is to combine a novel posturogrpahy based on HTC VIVE trackers and hybrid machine learning and deep learning algorithms to establish a set of simple, convenient and valid fall risk assessment tool. This observational and follow up study will community elderly aged over 60 years old. The investigators will collect demographic data, questionnaire surveys, traditional balance tests (Berg Balance scale, Timed-up-and-go, 30s-sit-to-stand, four-stage balance tests) and a tracker-based posturography to obtain the trunk stability parameters in different standing task. The fall risk will be classified according to self-reported falls in the past one year and verified in a 6-month follow up. The investigators will evaluate the performance of different hybrid machine learning and deep learning algorithm to extract the important features of multiple posturographic parameters and select an optimal model. The investigators will use the receiver operating characteristic curve analysis to compute the sensitivity, specificity and accuracy of different algorithms for risk classification and also compare the performance with traditional balance assessment tools. The investigators will evaluate the correlation of these posturographic features and data obtained by other methods. Risk factors of previous falls and future falls will also analyzed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - can walk in the household without device independently Exclusion Criteria: - with terminal disease - with cognitive impairment to follow verbal instruction - with neurological conditions that are associated with leg weakness - with significant visual impairment that interferes with daily living and walking

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
National Taiwan University Hospital National Taiwan University Hospital, Yun-Lin Branch, National Yunlin University of Science and Technology

References & Publications (1)

Liang HW, Chi SY, Chen BY, Hwang YH. Reliability and Validity of a Virtual Reality-Based System for Evaluating Postural Stability. IEEE Trans Neural Syst Rehabil Eng. 2021;29:85-91. doi: 10.1109/TNSRE.2020.3034876. Epub 2021 Feb 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of fall events self-reported fall events according to a followup questionnaire and defined as the sudden, involuntary transfer of body to the ground and at a lower level than the previous one 6 months
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