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

NCT ID: NCT06767163

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-02-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iBalance

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Authority Hong Kong West Cluster

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Xi Ning

Head of Department; Chair Professor of Robotics and Automation; Director of Advanced Technologies Institute, The University of Hong Kong

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Countries

Hong Kong

Central Contacts

Vivian W. Q. Lou, Ph.D.

Role: CONTACT

wlou@hku.hk

852-2831-5334

Iris Choi, MSW

Role: CONTACT

irischoi1@connect.hku.hk

852-5623-3496

Facility Contacts

Iris Choi, MSW

Role: primary

irischoi1@connect.hku.hk

852-56623-3496

Other Identifiers

UW 24-540

Identifier Type: -

Identifier Source: org_study_id