NCT04723927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

January 22, 2021

Last Update Submit

February 27, 2023

Conditions

Gait

Keywords

Fall prediction modelGait PatternMuscle activityBrain activityCardiopulmonary metabolic cost

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change on metabolic energy expenditure

    15 minutes

  • Change on muscle activity

    30 minutes

  • Change on brain activity

    30 minutes

  • Short Physical Performance Battery (SPPB)

    5 minutes

  • Four Square Step Test (FSST)

    5 minutes

  • +5 more secondary outcomes

Study Arms (1)

Older adults

The data for motor function and gait pattern analysis was obtained.

Other: Older adults

Interventions

Older adultsOTHER

The data for motor function and gait pattern analysis was obtained.

Older adults

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community seniors aged 65 to 84 years

You may qualify if:

  • Community seniors aged 65 to 84 years
  • A person who has no history of central nervous system disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37386363DERIVED

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

February 25, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

KR(1)