Developing a Daily-use Fall Risk Assessment Device in Clinical Setting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Older adults aged 60 years and above;
Understand Cantonese or Mandarin or English;
Clinical patients in the clinics.
Disqualifiers
Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
Inability to stand for 30 seconds without any assistance.
Trial design
Design model
Single group
Treatments tested in this trial
iBalance
DeviceParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
six monthsSecondary 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.
Time frame
six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Hospital Authority Hong Kong West Cluster
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: