Fall Detection and Prevention System for the Elderly

Accidental Falls Clinical Trial

Official title:

Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808831
• Other study ID #: VGHKS18-CT6-13
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Fooyin University
• Contact: I-Hsuan Chen, PhD
• Phone: +886-929130306
• Email: Y0894[@]fy.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.

The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.

Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.

Description:

Fall prevention is the most important issue for the elderly. Due to the low cost and convenience of wearable devices, numerous techniques have been developed to detect falls in clinical environment. However, such effects with large populations have not been established for the elderly. Another, existing systems mainly focus on detecting a fall with little emphasis on fall prediction and prevention. There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly.

The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up.

Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 65 years

• Able to walk independently for at least 5 m with or without the use of stick, quad stick or AFO

• With a history or fear of falls

• Able to follow the commands

Exclusion Criteria:

• With a severe cardiovascular, respiratory, musculoskeletal or neurological disorder

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Device:
• Fall detection and prevention system
The fall detection and prevention system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events.
• Sham fall detection and prevention system
The sham system with record but no alert function

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Fooyin University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in numbers of falls	An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level	Change from baseline numbers of falls at 6 weeks
Primary	Changes in numbers of falls	An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level	Change from baseline numbers of falls at 6 months
Primary	Changes in numbers of near-falls	A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated	Change from baseline numbers of near-falls at 6 weeks
Primary	Changes in numbers of near-falls	A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated	Change from baseline numbers of near-falls at 6 months
Primary	Changes in scores of Fall Efficacy Scale - International	Higher scores represent greater the fear of falling (ranging from 16 to 64)	Change from baseline scores at 6 weeks
Secondary	Changes in center of pressures (cm)	The point where the total sum of a pressure field acts on a body, causing a force to act through that point	Change from baseline postural sway at 6 weeks
Secondary	Changes in time (second) to perform timed up and go test	Longer time represents a worse outcome	Change from baseline time at 6 weeks
Secondary	Changes in scores of Berg Balance Scale	Higher values represent a better outcome (ranging from 0 to 56)	Change from baseline scores at 6 weeks
Secondary	Changes of walking speed (cm/s)	The speed at which participants choose to walk	Change from baseline speed at 6 weeks
Secondary	Changes in scores of Functional Gait Assessment	Higher values represent a better outcome (ranging from 0 to 30)	Change from baseline scores at 6 weeks
Secondary	Changes in scores of Physical Activity Scale for the Elderly	Higher scores represent a greater physical activity (ranging from 0 to 793)	Change from baseline scores at 6 weeks
Secondary	Changes is scores of Short-Form-12 Health Survey	Score > 50 indicate better physical or mental health than the mean	Change from baseline scores at 6 weeks