Fall Prevention in Elderly: Mechanisms and Strategies (STABLE)

January 8, 2024 updated by: Pengxu Wei, National Research Center for Rehabilitation Technical Aids

STrategies and mechAnisms of Community-Based falL Prevention in Elderly

In communities with over 100,000 residents, to investigate the incidence and mechanisms of fall in elderly, and strategies of fall prevention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100176
        • Recruiting
        • National Research Center for Rehabilitation Technical Aids
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100176
        • Not yet recruiting
        • National Research Center for Rehabilitation Technical Aids
        • Contact:
        • Principal Investigator:
          • PX Wei, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • community dwelling adults without medical conditions to impair walking ability

Exclusion Criteria:

  • cognitively or physically unable to cooperate with the examiner to finish the test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Elderly without fall history
Elderly people in the community who have no fall history
Behavioral: Exercise
Elderly people with or without fall history receive exercise to improve balance. Exercise interevention will be given 6 months in 2020. Outcomes (incidence of fall and biological tests) between two arms will be compared.
Other: Elderly with fall history
Elderly people in the community who have fall history
Behavioral: Exercise
Elderly people with or without fall history receive exercise to improve balance. Exercise interevention will be given 6 months in 2020. Outcomes (incidence of fall and biological tests) between two arms will be compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of fall
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months (reported once per year)
Incidence of fall each year
From date of recruitment until the end of the study, assessed up to 42 months (reported once per year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematics test
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months
During balance tests, assessing kinematics by using inertia sensors.
From date of recruitment until the end of the study, assessed up to 42 months
Kinetics test
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months
During balance tests, assessing kinetics by using sEMG (high-density surface EMG).
From date of recruitment until the end of the study, assessed up to 42 months
EEG test
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months
During balance tests, assessing brain mechanisms by using electroencephalogram (EEG).
From date of recruitment until the end of the study, assessed up to 42 months
fNIRS test
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months
During balance tests, assessing brain mechanisms by using functional near-infrared spectroscopy (fNIRS).
From date of recruitment until the end of the study, assessed up to 42 months
MRI assessments
Time Frame: From date of recruitment until the end of the study, assessed up to 42 months
Using functional magnetic resonance imaging to assess brain mechanisms during foot movements.
From date of recruitment until the end of the study, assessed up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Rehabilitation Technical Aids

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2018YFC2001401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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