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NCT Number: NCT06767163

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

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.

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Key information

Conditions

Falls Balance Assessment

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Precision assessment of falling risk prediction

    Time frame: six months

    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.

Secondary outcomes

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

    Time frame: six months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Iris Choi, MSW

CONTACT

[email protected]

852-5623-3496

Vivian W. Q. Lou, Ph.D.

CONTACT

[email protected]

852-2831-5334

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hospital Authority Hong Kong West Cluster

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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