NCT05308563

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

March 24, 2022

Last Update Submit

April 1, 2022

Conditions

Keywords

fall riskposturographymachine learningfall efficacydeep learning

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-living aged group

You may qualify if:

  • can walk in the household without device independently

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 33125332BACKGROUND

Biospecimen

Retention: NONE RETAINED

Trunk displacement trajectories recorded by the posturography

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 4, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

April 4, 2022

Record last verified: 2022-03