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Fall Detection and Prevention System for the Elderly

Not Applicable
Completed
Conditions
Accidental Falls
Interventions
Device: Fall detection and prevention system
Device: Sham fall detection and prevention system
Registration Number
NCT03808831
Lead Sponsor
Fooyin University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupsFall detection and prevention systemSubjects 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.
Sham groupSham fall detection and prevention systemIn the sham group, subjects wear a sham system with record but no alert function.
Primary Outcome Measures
NameTimeMethod
Changes in scores of Fall Efficacy Scale - InternationalChange from baseline scores at 6 weeks

Higher scores represent greater the fear of falling (ranging from 16 to 64)

Changes in numbers of fallsChange from baseline numbers of falls at 6 months

An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level

Changes in numbers of near-fallsChange from baseline numbers of near-falls at 6 months

A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated

Secondary Outcome Measures
NameTimeMethod
Changes is scores of Short-Form-12 Health SurveyChange from baseline scores at 6 weeks

Score \> 50 indicate better physical or mental health than the mean

Changes of walking speed (cm/s)Change from baseline speed at 6 weeks

The speed at which participants choose to walk

Changes in scores of Physical Activity Scale for the ElderlyChange from baseline scores at 6 weeks

Higher scores represent a greater physical activity (ranging from 0 to 793)

Changes in center of pressures (cm)Change from baseline postural sway at 6 weeks

The point where the total sum of a pressure field acts on a body, causing a force to act through that point

Changes in scores of Functional Gait AssessmentChange from baseline scores at 6 weeks

Higher values represent a better outcome (ranging from 0 to 30)

Changes in time (second) to perform timed up and go testChange from baseline time at 6 weeks

Longer time represents a worse outcome

Changes in scores of Berg Balance ScaleChange from baseline scores at 6 weeks

Higher values represent a better outcome (ranging from 0 to 56)

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital

🇨🇳

Kaohsiung, Taiwan

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