Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
NCT Number: NCT03808831
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.
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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Kaohsiung City, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The sham system with record but no alert function
Time frame: Change from baseline numbers of falls at 6 weeks
An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
Time frame: Change 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
Time frame: Change from baseline numbers of near-falls at 6 weeks
A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
Time frame: Change 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
Time frame: Change from baseline scores at 6 weeks
Higher scores represent greater the fear of falling (ranging from 16 to 64)
Time frame: 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
Time frame: Change from baseline time at 6 weeks
Longer time represents a worse outcome
Time frame: Change from baseline scores at 6 weeks
Higher values represent a better outcome (ranging from 0 to 56)
Time frame: Change from baseline speed at 6 weeks
The speed at which participants choose to walk
Time frame: Change from baseline scores at 6 weeks
Higher values represent a better outcome (ranging from 0 to 30)
Time frame: Change from baseline scores at 6 weeks
Higher scores represent a greater physical activity (ranging from 0 to 793)
Time frame: Change from baseline scores at 6 weeks
Score > 50 indicate better physical or mental health than the mean
Fooyin University
Other
Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
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