Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in scores of Fall Efficacy Scale - International
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •With a severe cardiovascular, respiratory, musculoskeletal or neurological disorder
结局指标
主要结局
Changes in scores of Fall Efficacy Scale - International
时间窗: Change from baseline scores at 6 weeks
Higher scores represent greater the fear of falling (ranging from 16 to 64)
Changes in numbers of falls
时间窗: 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
Changes in numbers of near-falls
时间窗: 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
次要结局
- Changes is scores of Short-Form-12 Health Survey(Change from baseline scores at 6 weeks)
- Changes of walking speed (cm/s)(Change from baseline speed at 6 weeks)
- Changes in scores of Physical Activity Scale for the Elderly(Change from baseline scores at 6 weeks)
- Changes in center of pressures (cm)(Change from baseline postural sway at 6 weeks)
- Changes in scores of Functional Gait Assessment(Change from baseline scores 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)
研究者
I-Hsuan Chen
Assistant professor
Fooyin University