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

NCT05693480 | Unknown

• 1 other identifier: ITB/FBL/4018/21/P
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fall; Balanced

Keywords

Fall prevention; Older adults; Balance ability assessement systems; Technology acceptance; Sensor

Outcome Measures

Primary Outcomes (1)

• Precision assessment of falling risk prediction

  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.

  Six Months

Secondary Outcomes (2)

• Validity of the balance ability measurement made by the device

  Six Months

• User Experience

  Six Months

Study Arms (1)

Intervention Group

EXPERIMENTAL

Older adults with zero time of falls in the past twelve months will be treated as the reference group. Older adults with at least one time of falls in the past twelve months will use the device to assess their balance ability by attending three rounds of the tests.

Device: Balance sensor

Interventions

Balance sensor DEVICE

Participants will engage in the device test, clinical assessment tests, and related user experience surveys to uncover problems in the effectiveness, efficiency, and acceptance of the device prototype. The whole test will last six months, and the outcome will be assessed pre- and post-implementation for comparison and validation. The major testing criteria include the validity and reliability of the device, user experiences, and the accuracy of the device's fall prediction.

Intervention Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60
• Ability to communicate with experiment operators (in Chinese or English)
• Ability to provide informed consent to participate after being given information about the experiment and other information that the participant must know to participate

You may not qualify if:

• Do not fall in the past twelve months
• Age ≥ 60
• Ability to communicate with experiment operators (in Chinese or English)
• Ability to provide informed consent to participate after being given information about the experiment and other information that the participant must know to participate
• Inability to give written informed consent (e.g., illiterate or with cognitive impairment)
• Inability to stand still without any assistance for 30 seconds

Sponsors & Collaborators

• The University of Hong Kong: lead
• Aberdeen Kai-fong Welfare Association: collaborator
• Hong Kong Young Women's Christian Association: collaborator

Study Sites (1)

Name: The University of Hong Kong

Hong Kong, 999777, Hong Kong

RECRUITING

Central Study Contacts

Vivian W. Q. Lou

CONTACT

2831-5334/3917-4835; wlou@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor of Robotics and Automation; Director of Emerging Technologies Institute

Model Details: Reference group: A total of 300 older adults who do not have any fall history in the past twelve months will be recruited for participating in three rounds of tests. Intervention group: A total of 1000 older adults who have fall history in the past twelve months will be recruited for participating in three rounds of tests.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: No limitations on the publications
• Access Criteria: No limitations on the publications

Locations

HK (1)