Fall Detection and Prevention System for the Elderly

NCT03808831 | Completed

• 1 other identifier: VGHKS18-CT6-13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Accidental Falls

Keywords

Fall detection; Fall prevention; Accelerometer; Elderly

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Changes in center of pressures (cm)

  Change from baseline postural sway at 6 weeks

• Changes in time (second) to perform timed up and go test

  Change from baseline time at 6 weeks

• Changes in scores of Berg Balance Scale

  Change from baseline scores at 6 weeks

• Changes of walking speed (cm/s)

  Change from baseline speed at 6 weeks

• Changes in scores of Functional Gait Assessment

  Change from baseline scores at 6 weeks

Study Arms (2)

Experimental groups

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

In the sham group, subjects wear a sham system with record but no alert function.

Device: Sham fall detection and prevention system

Interventions

Fall detection and prevention system DEVICE

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.

Experimental groups

Sham fall detection and prevention system DEVICE

The sham system with record but no alert function

Sham group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Study Officials

• I-Hsuan Chen, PhD

  Department of Physical therapy, Fooyin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: January 20, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)