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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06767163
Enrollment
20
Registered
2025-01-09
Start date
2025-02-01
Completion date
2026-02-01
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Assessment, Falls

Keywords

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

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.

Interventions

DEVICEiBalance

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.

Sponsors

Hospital Authority Hong Kong West Cluster
CollaboratorUNKNOWN
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Precision assessment of falling risk predictionsix monthsA 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

MeasureTime frameDescription
Feasibility of fall risk assessment by using balance sensor in clinical settingssix monthsThe 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.

Countries

Hong Kong

Contacts

Primary ContactVivian W. Q. Lou, Ph.D.
wlou@hku.hk852-2831-5334
Backup ContactIris Choi, MSW
irischoi1@connect.hku.hk852-5623-3496

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026