Accidental FallsNCT03808831
Fall Detection and Prevention System for the Elderly
A study testing Fall detection and prevention system in people with Accidental Falls, run by Fooyin University at 1 site in Taiwan.
Trial summary
There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Fall detection and prevention system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jan 2019to 31 Dec 2019
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Able to walk independently for at least 5 m with or without the use of stick, quad stick or AFO
- With a history or fear of falls
- Able to follow the commands
Who cannot join
- With a severe cardiovascular, respiratory, musculoskeletal or neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.
The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.
Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.
Read the detailed description
Fall prevention is the most important issue for the elderly. Due to the low cost and convenience of wearable devices, numerous techniques have been developed to detect falls in clinical environment. However, such effects with large populations have not been established for the elderly. Another, existing systems mainly focus on detecting a fall with little emphasis on fall prediction and prevention. There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.
The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.
Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.
- Conditions
- Accidental Falls
- Being tested
- Fall detection and prevention system, Sham fall detection and prevention system
- Keywords
- Fall detection, Fall prevention, Accelerometer, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall detection and prevention systemDevice
The fall detection and prevention system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events.
Sham fall detection and prevention systemDevice
The sham system with record but no alert function
| Study group | Role | What they receive |
|---|---|---|
| Experimental groups | Experimental | Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. Receives: Device: Fall detection and prevention system |
| Sham group | Sham comparator | In the sham group, subjects wear a sham system with record but no alert function. Receives: Device: Sham fall detection and prevention system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in numbers of falls
An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
Measured: Change from baseline numbers of falls at 6 weeks
Changes in numbers of falls
An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
Measured: Change from baseline numbers of falls at 6 months
Changes in numbers of near-falls
A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
Measured: Change from baseline numbers of near-falls at 6 weeks
Changes in numbers of near-falls
A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
Measured: Change from baseline numbers of near-falls at 6 months
Changes in scores of Fall Efficacy Scale - International
Higher scores represent greater the fear of falling (ranging from 16 to 64)
Measured: Change from baseline scores at 6 weeks
Secondary outcomes (7)
Changes in center of pressures (cm)
The point where the total sum of a pressure field acts on a body, causing a force to act through that point
Measured: Change from baseline postural sway at 6 weeks
Changes in time (second) to perform timed up and go test
Longer time represents a worse outcome
Measured: Change from baseline time at 6 weeks
Changes in scores of Berg Balance Scale
Higher values represent a better outcome (ranging from 0 to 56)
Measured: Change from baseline scores at 6 weeks
Changes of walking speed (cm/s)
The speed at which participants choose to walk
Measured: Change from baseline speed at 6 weeks
Changes in scores of Functional Gait Assessment
Higher values represent a better outcome (ranging from 0 to 30)
Measured: Change from baseline scores at 6 weeks
Changes in scores of Physical Activity Scale for the Elderly
Higher scores represent a greater physical activity (ranging from 0 to 793)
Measured: Change from baseline scores at 6 weeks
Changes is scores of Short-Form-12 Health Survey
Score > 50 indicate better physical or mental health than the mean
Measured: Change from baseline scores at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start20 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Hsuan Chen, Fooyin University
- Investigators
- I-Hsuan Chen, PhD, Principal investigator, Department of Physical therapy, Fooyin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808831
- Sponsor's protocol ID
- VGHKS18-CT6-13
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
- ClinicalTrials.gov ID
- NCT03808831
- Acronym / sponsor ID
- VGHKS18-CT6-13
- Conditions
- Accidental Falls
- Keywords
- Fall detection, Fall prevention, Accelerometer, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2019 (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.
There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.
The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.
Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.
Detailed description
Fall prevention is the most important issue for the elderly. Due to the low cost and convenience of wearable devices, numerous techniques have been developed to detect falls in clinical environment. However, such effects with large populations have not been established for the elderly. Another, existing systems mainly focus on detecting a fall with little emphasis on fall prediction and prevention. There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.
The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.
Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental groups | Experimental | Device: Fall detection and prevention systemSubjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. |
| Sham group | Sham comparator | Device: Sham fall detection and prevention systemIn the sham group, subjects wear a sham system with record but no alert function. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Able to walk independently for at least 5 m with or without the use of stick, quad stick or AFO
- With a history or fear of falls
- Able to follow the commands
Key exclusion criteria (1 listed)
- With a severe cardiovascular, respiratory, musculoskeletal or neurological disorder
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 |
|---|---|---|
| Fall detection and prevention systemThe fall detection and prevention system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. | Device | Experimental groups |
| Sham fall detection and prevention systemThe sham system with record but no alert function | Device | Sham group |
Primary outcome
Changes in numbers of falls
Time frame: Change from baseline numbers of falls at 6 weeks
An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
Changes in numbers of falls
Time frame: Change from baseline numbers of falls at 6 months
An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
Changes in numbers of near-falls
Time frame: Change from baseline numbers of near-falls at 6 weeks
A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
Changes in numbers of near-falls
Time frame: Change from baseline numbers of near-falls at 6 months
A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
Changes in scores of Fall Efficacy Scale - International
Time frame: Change from baseline scores at 6 weeks
Higher scores represent greater the fear of falling (ranging from 16 to 64)
7 secondary outcomes
Changes in center of pressures (cm)
Time frame: Change from baseline postural sway at 6 weeks
Changes in time (second) to perform timed up and go test
Time frame: Change from baseline time at 6 weeks
Changes in scores of Berg Balance Scale
Time frame: Change from baseline scores at 6 weeks
Changes of walking speed (cm/s)
Time frame: Change from baseline speed at 6 weeks
Changes in scores of Functional Gait Assessment
Time frame: Change from baseline scores at 6 weeks
Changes in scores of Physical Activity Scale for the Elderly
Time frame: Change from baseline scores at 6 weeks
Changes is scores of Short-Form-12 Health Survey
Time frame: Change from baseline scores at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
I-Hsuan Chen, PhD principal investigator
Department of Physical therapy, Fooyin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall detection and prevention system in people with Accidental Falls, run by Fooyin University at 1 site in Taiwan.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in numbers of falls (time frame: Change from baseline numbers of falls at 6 weeks). The study lists 5 primary outcomes in all. 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 17 Mar 2025.