GaitNCT04723927
Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data
An observational study of Gait, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aimed to develop a fall prediction model for older adults by measuring the multi-faceted biosignal data to classify the walking patterns and by identifying causal relationships with the variables that affect the fall. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait
- What is being tested?
- Older adults
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2021to 31 Aug 2022
- Phase
- Observational
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community seniors aged 65 to 84 years
Who may be able to join
- Community seniors aged 65 to 84 years
- A person who has no history of central nervous system disease
Who cannot join
- Older adults who are unable to walk independently due to vision loss, fractures, etc.
- An elderly person who had musculoskeletal history that could cause problems in the function of the lower extremities, such as fractures, within three months before recruitment;
- In case it is difficult to understand the task due to severe cognitive impairment (Korean simplified mental health examination, K-MMSE score 10 or less)
- In the event of a serious mental illness, such as schizophrenia or bipolar disorder;
- In case of severe dizziness and difficulty in pedestrian inspection
- Persons not eligible for examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Fall Prediction Model for Older Adults by Analysis of Walking Patterns Based on Multi-faceted Biosignal Data
This study aimed to develop a fall prediction model for older adults by measuring the multi-faceted biosignal data to classify the walking patterns and by identifying causal relationships with the variables that affect the fall.
Read the detailed description
This study aimed to develop a fall prediction model by measuring the multi-paceted biosignal data for the elderly's physical function and walking to classify the walking patterns of the elderly, and by identifying causal relationships and influences with the variables that affect the fall.
- Conditions
- Gait
- Being tested
- Older adults
- Keywords
- Fall prediction model, Gait Pattern, Muscle activity, Brain activity, Cardiopulmonary metabolic cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Older adultsOther
The data for motor function and gait pattern analysis was obtained.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | The data for motor function and gait pattern analysis was obtained. Receives: Other: Older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.
All participants perform overground walking to assess the change of kinematic, kinetic and muscle activation using a motion analysis and surface EMG
Measured: 1 hour
Secondary outcomes (10)
Change on metabolic energy expenditure
All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes.
It assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
Measured: 15 minutes
Change on muscle activity
All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes
Measured: 30 minutes
Change on brain activity
All subjects underwent measurements of brain activity by measuring fNIRS during treadmill walking at a comfortable speed and high speed for 5 minutes
Measured: 30 minutes
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility in older people.
Measured: 5 minutes
Four Square Step Test (FSST)
The Four Square Step Test (FSST) is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward.
Measured: 5 minutes
The Timed Up and Go test (TUG)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 5 minutes
10 meter walk test (10MWT)
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
Measured: 5 minutes
Modified Bathel index (MBI)
The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.
Measured: 5 minutes
6 minutes walking test (6MWT)
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: 6 minutes
Fall Efficacy Scale (FES)
The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Feb 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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 GaitStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
- Investigators
- Yun-Hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723927
- Sponsor's protocol ID
- 2020-09-172
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung E, Lee SH, Lee HJ, Kim YH. Comparative study of young-old and old-old people using functional evaluation, gait characteristics, and cardiopulmonary metabolic energy consumption. BMC Geriatr. 2023 Jun 29;23(1):400. doi: 10.1186/s12877-023-04088-6.
PubMed 37386363
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Fall Prediction Model for Older Adults by Analysis of Walking Patterns Based on Multi-faceted Biosignal Data
- ClinicalTrials.gov ID
- NCT04723927
- Acronym / sponsor ID
- 2020-09-172
- Conditions
- Gait
- Keywords
- Fall prediction model, Gait Pattern, Muscle activity, Brain activity, Cardiopulmonary metabolic cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Jan 2021 (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.
This study aimed to develop a fall prediction model for older adults by measuring the multi-faceted biosignal data to classify the walking patterns and by identifying causal relationships with the variables that affect the fall.
Detailed description
This study aimed to develop a fall prediction model by measuring the multi-paceted biosignal data for the elderly's physical function and walking to classify the walking patterns of the elderly, and by identifying causal relationships and influences with the variables that affect the fall.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | Other: Older adultsThe data for motor function and gait pattern analysis was obtained. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community seniors aged 65 to 84 years
Key inclusion criteria (2 listed)
- Community seniors aged 65 to 84 years
- A person who has no history of central nervous system disease
Key exclusion criteria (6 listed)
- Older adults who are unable to walk independently due to vision loss, fractures, etc.
- An elderly person who had musculoskeletal history that could cause problems in the function of the lower extremities, such as fractures, within three months before recruitment;
- In case it is difficult to understand the task due to severe cognitive impairment (Korean simplified mental health examination, K-MMSE score 10 or less)
- In the event of a serious mental illness, such as schizophrenia or bipolar disorder;
- In case of severe dizziness and difficulty in pedestrian inspection
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 |
|---|---|---|
| Older adultsThe data for motor function and gait pattern analysis was obtained. | Other | Older adults |
Primary outcome
Gait analysis
Time frame: 1 hour
Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system. All participants perform overground walking to assess the change of kinematic, kinetic and muscle activation using a motion analysis and surface EMG
10 secondary outcomes
Change on metabolic energy expenditure
Time frame: 15 minutes
Change on muscle activity
Time frame: 30 minutes
Change on brain activity
Time frame: 30 minutes
Short Physical Performance Battery (SPPB)
Time frame: 5 minutes
Four Square Step Test (FSST)
Time frame: 5 minutes
The Timed Up and Go test (TUG)
Time frame: 5 minutes
10 meter walk test (10MWT)
Time frame: 5 minutes
Modified Bathel index (MBI)
Time frame: 5 minutes
6 minutes walking test (6MWT)
Time frame: 6 minutes
Fall Efficacy Scale (FES)
Time frame: 5 minutes
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 1 Mar 2023.
- Derived from this study: PubMed 37386363Chung E, Lee SH, Lee HJ, Kim YH. Comparative study of young-old and old-old people using functional evaluation, gait characteristics, and cardiopulmonary metabolic energy consumption. BMC Geriatr. 2023 Jun 29;23(1):400. doi: 10.1186/s12877-023-04088-6.
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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.
Yun-Hee Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 6 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 1 Mar 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 South Korea. 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?
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?
Gait analysis (time frame: 1 hour). 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 NCT04723927, 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 1 Mar 2023.