Developing a Daily-use Fall Risk Assessment Device in Clinical Setting

NCT06767163 | Not Yet Recruiting

• 1 other identifier: UW 24-540
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives Objective 1: Compare the fall risk assessment results between balance sensors, traditional tests, and clinical diagnoses. Objective 2: Improve the feasibility of using sensors to assess fall risk among older patients in the hospital. The investigators select Hong Kong as the region for the experiment. Specifically, the community clinics and daytime hospitals are the actual onsite locations for experimenting. The specific venues of these locations need an electrical power supply and a flat ground for conducting the device test. Patients will be recruited for the development and testing of a device for fall risk assessment, study participants will be involved in balancing assessments, and questionnaire surveys, their medical records will be accessed. And during these tests and questionnaire surveys, the investigators will take photos, videos, and or audio recordings.

Conditions

Falls; Balance Assessment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Precision assessment of falling risk prediction

  A primary outcome is the precision assessment of falling risk prediction both from device and clinical diagnose. The specific measurement variables for this primary outcome are the classification results of high/low falling risk based on the results (a composite result) 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 (eg. the history of the emergency, surgery, and diagnosed disease in the past three years), as well as the diagnosis results of the fall risk by clinical professionals. These results can be shown through the sensitivity and specificity analysis of the device evaluation.

  six months

Secondary Outcomes (1)

• Feasibility of fall risk assessment by using balance sensor in clinical settings

  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: iBalance

Interventions

iBalance DEVICE

Participants will engage in the device test, clinical assessment tests. The whole test will last twelve months, and the outcome will be assessed pre- and post-implementation for comparison and validation. The intervention results are used to compared with traditional tests and clinical diagnosis, to identify whether the sensor provides a higher accuracy in predicting fall risk, and to explore the feasibility of the sensor in clinical scenarios.

Intervention Group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 years and above;
• Understand Cantonese or Mandarin or English;
• Clinical patients in the clinics.

You may not qualify if:

• Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
• Inability to stand for 30 seconds without any assistance.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority Hong Kong West Cluster: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, 999777, Hong Kong

Location

Central Study Contacts

Vivian W. Q. Lou, Ph.D.

CONTACT

852-2831-5334; wlou@hku.hk

Iris Choi, MSW

CONTACT

852-5623-3496; irischoi1@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department; Chair Professor of Robotics and Automation; Director of Advanced Technologies Institute, The University of Hong Kong

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

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

Locations

HK (1)