Fall Detection and Prevention System for the Elderly

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Accidental Falls

Intervention / Treatment
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* Device: Fall detection and prevention system
* Device: Sham fall detection and prevention system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall detection, Fall prevention, Accelerometer, Elderly