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FallITF-BalanceNCT05693480

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

A study testing Balance sensor in people with Fall and Balanced, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research attempts to develop an artificial intelligence (AI) enabled device for measuring the dynamic balance ability of older people with a sensor using an optical principle called Frustrated Total Internal Reflection. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Fall, Balanced
What is being tested?
Balance sensor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
1 siteHong Kong
Study dates
1 Jul 2022to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60
  • Ability to communicate with experiment operators (in Chinese or English)
  • Ability to provide informed consent to participate after being given information about the experiment and other information that the participant must know to participate
  • Age ≥ 60
  • Ability to communicate with experiment operators (in Chinese or English)
  • Ability to provide informed consent to participate after being given information about the experiment and other information that the participant must know to participate

Who cannot join

  • Do not fall in the past twelve months
  • Inability to give written informed consent (e.g., illiterate or with cognitive impairment)
  • Inability to stand still without any assistance for 30 seconds

Trial locations and contacts

1 site in 1 country.

Vivian W. Q. Lou contact

2831-5334/3917-4835

wlou@hku.hk

Hong Kong1 site, 1 recruiting
  • Name: The University of Hong Kong

    Hong Kong, 999777

    Xiaobo Ke, 3917-0060, xiaoboke@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

This research attempts to develop an artificial intelligence (AI) enabled device for measuring the dynamic balance ability of older people with a sensor using an optical principle called Frustrated Total Internal Reflection. The AI-based algorithm embedded in the device performs the data analysis for balance ability assessment and falling risk prediction. As a critical part of the research, a large-scale user study is needed to test the validity of the device regarding the dynamic balance ability assessment and the accuracy of the falling risk prediction provided by the device. Also, we plan to study the factors influencing user engagement in this device through the questionnaire-based survey and interview.

Read the detailed description

Falling is a significant threat to the health and independent living quality of the elderly. The loss of balance leads to falls. Balance is a very complex neuromuscular reflex function that may be affected by the general condition of the body and one or more impairments in the sensory, nervous, cardiovascular, and musculoskeletal systems. Currently, no test or tool can directly measure balancing capability in the clinical setting. Most clinicians use proxy-based methods to estimate the likelihood of falling, such as the Timed Up and Go Test which has low diagnostic accuracy. Other commonly used observational fall assessment tools (e.g., Berg Balance Scale and Performance-Oriented Mobility Assessment) require long administration time, suffering ceiling effects and subjective judgment. The computerized dynamic posturography devices are used in specialized fall assessment and rehabilitation centers. However, these devices are not routinely used in clinical or home settings due to high user costs and special training requirements.

To overcome the abovementioned limitations of extant approaches for measuring dynamic balance ability and predicting the risk of falling. This research attempts to develop an artificial intelligence (AI) enabled device for measuring the dynamic balance ability of older people with a sensor using an optical principle called Frustrated Total Internal Reflection (FTIR). The AI-based algorithm embedded in the device performs the data analysis for balance ability assessment and falling risk prediction.

As a critical part of the research, a large-scale user study is needed to test the validity of the device regarding the dynamic balance ability assessment compared with the common clinical assessment tools used by doctors and other healthcare professionals. In addition, this large-scale user study will also investigate the accuracy of the falling risk prediction provided by the device. Also, the investigators plan to study the factors influencing user engagement in this device through the questionnaire-based survey.

The targeted direct user group of this device is people aged 60 years old or above who live in Hong Kong. The whole study will last six months, and the outcome will be assessed pre-and post-implementation for comparison and validation. The major testing criteria include the device specifications for validity and reliability, user experiences and adoption, prediction model accuracy.

First Round: The participant will be invited to take three tests: A device test, a time up and go test, and a Berg balance test. The device test involves five simple tasks that require participants to complete while using the balance sensor to assess the balance ability. In addition, participants will be required to complete physical data measurements to collect the weight, height, blood pressure, muscle mass, body mass index (BMI), and other physical data. Besides, participants will be required to complete questionnaires.

Second Round (after 90 days): Participants will be invited to participate in the device test: The device test involves five simple tasks that request participants to finish when using the device to assess participants' balance ability. Besides, after the tests, participants are invited to fill out a questionnaire.

Third Round (after 180 days): Participants will be invited to participate in the device test: The device test involves five simple tasks that request participants to finish when using the device to assess the balance ability. Besides, after the tests, participants are invited to fill out a questionnaire.

Investigators will conduct three types of analysis to suit the project needs. First, the investigators will use Descriptive Statistics to summarize demographic information, test results of baseline test and device test, as well as the participant responses to the surveys. Also, the investigators will transform any skewed variables and correct their skewness by means of log transformation before inferential analysis. To assess normality, the investigators will perform the Shapiro-Wilk test of normality as well as the normal Q-Q Plot. Second, the investigators will apply Bivariate Correlation Analysis (Pearson, Two-tailed) to verify the validity of the balance ability assessment of the device. Third, the investigators will apply the Discriminant Analysis (i.e., sensitivity and specificity analysis) to verify the precision of the falling risk prediction provided by the device.

The principal investigator will be responsible for the safekeeping of the personal data of participants during and after the experiment. These data will be used for academic and clinical research only. Moreover, the data with the identifiable information will be kept for up to 5 years after the first publication. Anonymous data will be kept for up to 10 years after the first publication arising from this project. All information obtained will be used for research purposes only. All the data will be stored in an encrypted workstation and on password-protected online cloud storage.

Conditions
Fall, Balanced
Being tested
Balance sensor
Keywords
Fall prevention, Older adults, Balance ability assessement systems, Technology acceptance, Sensor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balance sensorDevice

    Participants will engage in the device test, clinical assessment tests, and related user experience surveys to uncover problems in the effectiveness, efficiency, and acceptance of the device prototype. The whole test will last six months, and the outcome will be assessed pre- and post-implementation for comparison and validation. The major testing criteria include the validity and reliability of the device, user experiences, and the accuracy of the device's fall prediction.

Study groups in NCT05693480
Study groupRoleWhat they receive
Intervention GroupExperimentalOlder 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: Balance sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Precision assessment of falling risk prediction

    A primary outcome is the precision assessment of falling risk prediction. The specific measurement variables for this primary outcome are the classification results of high/low falling risk based on the scoring results (a composite result, namely Falling Probability (FP)) 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 (say, the falls history within past six months). The FP ranges from zero to one, in which the higher score indicates a higher possibility of fall. The analysis metric for this primary outcome is sensitivity and specificity performance analysis of the device assessment.

    Measured: Six Months

Secondary outcomes (2)
  1. Validity of the balance ability measurement made by the device

    The secondary outcome is the validity of the balance ability measurement made by the device. The specific measurement variables for this secondary outcome are the balance ability score measured by the baseline tests and the balance ability score measured by the device test. The analysis metric for this secondary outcome is the correlation coefficient and the significant level of the correlation between the balance ability score of the device test and the balance ability score of baseline tests.

    Measured: Six Months

  2. User Experience

    The survey data about user experience and adoption would also be a secondary measurement. We will conduct structural equation modeling to identify an effective model explaining user adoption. This model could guide us in improving our device development.

    Measured: Six Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Reference group: A total of 300 older adults who do not have any fall history in the past twelve months will be recruited for participating in three rounds of tests. Intervention group: A total of 1000 older adults who have fall history in the past twelve months will be recruited for participating in three rounds of tests.
Masking
None (open label)
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05693480
Sponsor's protocol ID
ITB/FBL/4018/21/P
Acronym
ITF-Balance
Status last verified
Feb 2023
First submitted
11 Jan 2023
Last updated
8 Feb 2023
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.

Questions about this trial

What is this clinical trial studying?

A study testing Balance sensor in people with Fall and Balanced, 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vivian W. Q. Lou (2831-5334/3917-4835, 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?
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 8 Feb 2023.

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