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Completed

NCT Number: NCT04723927

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

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Key information

Conditions

Gait

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Older adults

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change on metabolic energy expenditure

    Time frame: 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).

  2. Change on muscle activity

    Time frame: 30 minutes

    All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes

  3. Change on brain activity

    Time frame: 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

  4. Short Physical Performance Battery (SPPB)

    Time frame: 5 minutes

    The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility in older people.

  5. Four Square Step Test (FSST)

    Time frame: 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.

  6. The Timed Up and Go test (TUG)

    Time frame: 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.

  7. 10 meter walk test (10MWT)

    Time frame: 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."

  8. Modified Bathel index (MBI)

    Time frame: 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.

  9. 6 minutes walking test (6MWT)

    Time frame: 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.

  10. Fall Efficacy Scale (FES)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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