Fall Prevention in Elderly: Mechanisms and Strategies

Elderly Clinical Trial

— STABLE  

Official title:

STrategies and mechAnisms of Community-Based falL Prevention in Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981471
• Other study ID #: 2018YFC2001401
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: National Research Center for Rehabilitation Technical Aids
• Contact: HL Su, Dr
• Phone: 86-10-58122882
• Email: suhonglun[@]nrcrta.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

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.

Locations

Country	Name	City	State
China	National Research Center for Rehabilitation Technical Aids	Beijing	Beijing
China	National Research Center for Rehabilitation Technical Aids	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center for Rehabilitation Technical Aids	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fall	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	Kinematics test	During balance tests, assessing kinematics by using inertia sensors.	From date of recruitment until the end of the study, assessed up to 42 months
Secondary	Kinetics test	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
Secondary	EEG test	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
Secondary	fNIRS test	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
Secondary	MRI assessments	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