FallsNCT06767163
Developing a Daily-use Fall Risk Assessment Device in Clinical Setting
A study testing iBalance in people with Falls and Balance Assessment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls, Balance Assessment
- What is being tested?
- iBalance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults aged 60 years and above;
- Understand Cantonese or Mandarin or English;
- Clinical patients in the clinics.
Who cannot join
- Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
- Inability to stand for 30 seconds without any assistance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The University of Hong Kong
Hong Kong, Hong Kong, 999777
Iris Choi, MSW, 852-56623-3496, irischoi1@connect.hku.hk
About this study
Official title: 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.
- Conditions
- Falls, Balance Assessment
- Being tested
- iBalance
- Keywords
- Fall prevention, Older adults, Balance ability assessement systems, Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iBalanceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iBalance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority Hong Kong West Cluster
- Responsible party
- Principal investigator, Prof. Xi Ning, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767163
- Sponsor's protocol ID
- UW 24-540
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be published and submitted to academic journals to share with other researchers.
Publications
Liu H, Cai L, Ma X, Chen J, Lam CLK, Yuen JKY, Chan CP, Sze HH, Wang HL, Xi N, Lou VW. Evaluation of a Frustrated Total Internal Reflection (FTIR) based balance sensor for objective fall risk assessment in older adults: a study protocol. BMC Geriatr. 2026 Mar 2;26(1):466. doi: 10.1186/s12877-026-07253-9.
PubMed 41772485
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Applications of Daily-use Fall Risk Assessment Device to Prevent Elderly People from Falling
- ClinicalTrials.gov ID
- NCT06767163
- Acronym / sponsor ID
- UW 24-540
- Conditions
- Falls, Balance Assessment
- Keywords
- Fall prevention, Older adults, Balance ability assessement systems, Sensor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority Hong Kong West Cluster
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: iBalanceOlder 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older adults aged 60 years and above;
- Understand Cantonese or Mandarin or English;
- Clinical patients in the clinics.
Key exclusion criteria (2 listed)
- Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
- Inability to stand for 30 seconds without any assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iBalanceParticipants 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. | Device | Intervention Group |
Primary outcome
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.
1 secondary outcome
Feasibility of fall risk assessment by using balance sensor in clinical settings
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 41772485Liu H, Cai L, Ma X, Chen J, Lam CLK, Yuen JKY, Chan CP, Sze HH, Wang HL, Xi N, Lou VW. Evaluation of a Frustrated Total Internal Reflection (FTIR) based balance sensor for objective fall risk assessment in older adults: a study protocol. BMC Geriatr. 2026 Mar 2;26(1):466. doi: 10.1186/s12877-026-07253-9.
- Individual participant dataSharing planned: Yes. Data collected in this study will be published and submitted to academic journals to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iBalance in people with Falls and Balance Assessment, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian W. Q. Lou, Ph.D. (852-2831-5334, wlou@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision assessment of falling risk prediction (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.