- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723927
Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data
Development of Fall Prediction Model for Older Adults by Analysis of Walking Patterns Based on Multi-faceted Biosignal Data
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Community seniors aged 65 to 84 years
- A person who has no history of central nervous system disease
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Older adults
The data for motor function and gait pattern analysis was obtained.
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The data for motor function and gait pattern analysis was obtained.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait analysis
Time Frame: 1 hour
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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 |
1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on metabolic energy expenditure
Time Frame: 15 minutes
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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). |
15 minutes
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Change on muscle activity
Time Frame: 30 minutes
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All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes
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30 minutes
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Change on brain activity
Time Frame: 30 minutes
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All subjects underwent measurements of brain activity by measuring fNIRS during treadmill walking at a comfortable speed and high speed for 5 minutes
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30 minutes
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Short Physical Performance Battery (SPPB)
Time Frame: 5 minutes
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The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility in older people.
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5 minutes
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Four Square Step Test (FSST)
Time Frame: 5 minutes
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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.
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5 minutes
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The Timed Up and Go test (TUG)
Time Frame: 5 minutes
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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.
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5 minutes
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10 meter walk test (10MWT)
Time Frame: 5 minutes
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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."
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5 minutes
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Modified Bathel index (MBI)
Time Frame: 5 minutes
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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.
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5 minutes
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6 minutes walking test (6MWT)
Time Frame: 6 minutes
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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.
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6 minutes
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Fall Efficacy Scale (FES)
Time Frame: 5 minutes
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The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident.
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5 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-09-172
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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