Fall Detection and Prevention System for the Elderly

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

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.

Study Overview

• Status: Unknown
• Conditions: Accidental Falls
• Intervention / Treatment: Device: Fall detection and prevention system; Device: Sham fall detection and prevention system

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I-Hsuan Chen, PhD; Phone Number: +886-929130306; Email: Y0894@fy.edu.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Veterans General Hospital
    • Contact: I-Hsuan Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental groups; 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.	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 Comparator: Sham group; In the sham group, subjects wear a sham system with record but no alert function.	Device: Sham fall detection and prevention system; The sham system with record but no alert function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in time (second) to perform timed up and go test	Longer time represents a worse outcome	Change from baseline time at 6 weeks
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
Changes of walking speed (cm/s)	The speed at which participants choose to walk	Change from baseline speed at 6 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Fooyin University
• Investigators: Principal Investigator: I-Hsuan Chen, PhD, Department of Physical therapy, Fooyin University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Fall prevention; Accelerometer; Fall detection
• Other Study ID Numbers: VGHKS18-CT6-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No