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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Falls; Balance Assessment
• Intervention / Treatment: Device: iBalance

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivian W. Q. Lou, Ph.D.; Phone Number: 852-2831-5334; Email: wlou@hku.hk
• Study Contact Backup: Name: Iris Choi, MSW; Phone Number: 852-5623-3496; Email: irischoi1@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999777
    • The University of Hong Kong
    • Contact: Iris Choi, MSW; Phone Number: 852-56623-3496; Email: irischoi1@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of fall risk assessment by using balance sensor in clinical settings	The secondary outcome is the specific fall risk results given by the device and the participant's body data measurement, demographic information, and survey data about user experience and adoption. Additionally, the ideas from clinical professionals on the better application of the device in hospitals will also be regarded as the secondary outcome of this study.	six months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority Hong Kong West Cluster

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Older adults; Fall prevention; Sensor; Balance ability assessement systems
• Other Study ID Numbers: UW 24-540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected in this study will be published and submitted to academic journals to share with other researchers.
• IPD Sharing Time Frame: No limitations on the publications
• IPD Sharing Access Criteria: No limitations on the publications
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No