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

Completed

• Conditions: Gait
• Interventions: Other: Older adults

• Registration Number: NCT04723927
• Lead Sponsor: Samsung Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Study Start: 2021-02-25
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older adults	Older adults	The data for motor function and gait pattern analysis was obtained.

Primary Outcome Measures

Name	Time	Method
Gait analysis	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

Secondary Outcome Measures

Name	Time	Method
10 meter walk test (10MWT)	5 minutes	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."
Change on metabolic energy expenditure	15 minutes	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).
Change on muscle activity	30 minutes	All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes
Short Physical Performance Battery (SPPB)	5 minutes	The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility in older people.
6 minutes walking test (6MWT)	6 minutes	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.
Fall Efficacy Scale (FES)	5 minutes	The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident.
The Timed Up and Go test (TUG)	5 minutes	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.
Change on brain activity	30 minutes	All subjects underwent measurements of brain activity by measuring fNIRS during treadmill walking at a comfortable speed and high speed for 5 minutes
Four Square Step Test (FSST)	5 minutes	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.
Modified Bathel index (MBI)	5 minutes	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of