Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data

Gait Clinical Trial

Official title:

Development of Fall Prediction Model for Older Adults by Analysis of Walking Patterns Based on Multi-faceted Biosignal Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723927
• Other study ID #: 2020-09-172
• Status: Completed
• Start date: February 25, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait

Intervention

Other:
• Older adults
The data for motor function and gait pattern analysis was obtained.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour
Secondary	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).	15 minutes
Secondary	Change on muscle activity	All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes	30 minutes
Secondary	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	30 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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."	5 minutes
Secondary	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.	5 minutes
Secondary	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.	6 minutes
Secondary	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.	5 minutes