Clinical trial NCT03808831: Fall Detection and Prevention System for the Elderly
Official title: Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Fall detection
Fall prevention
Accelerometer
Elderly
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in numbers of falls
timeFrame: Change from baseline numbers of falls at 6 weeks
measure: Changes in numbers of falls
timeFrame: Change from baseline numbers of falls at 6 months
measure: Changes in numbers of near-falls
timeFrame: Change from baseline numbers of near-falls at 6 weeks
measure: Changes in numbers of near-falls
timeFrame: Change from baseline numbers of near-falls at 6 months
measure: Changes in scores of Fall Efficacy Scale - International
timeFrame: Change from baseline scores at 6 weeks
Secondary outcomes:
measure: Changes in center of pressures (cm)
timeFrame: Change from baseline postural sway at 6 weeks
measure: Changes in time (second) to perform timed up and go test
timeFrame: Change from baseline time at 6 weeks
measure: Changes in scores of Berg Balance Scale
timeFrame: Change from baseline scores at 6 weeks
measure: Changes of walking speed (cm/s)
timeFrame: Change from baseline speed at 6 weeks
measure: Changes in scores of Functional Gait Assessment
timeFrame: Change from baseline scores at 6 weeks
measure: Changes in scores of Physical Activity Scale for the Elderly
timeFrame: Change from baseline scores at 6 weeks
measure: Changes is scores of Short-Form-12 Health Survey
timeFrame: Change from baseline scores at 6 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Physical therapy, Fooyin University
name: I-Hsuan Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: