Fall Detection and Prevention System for the Elderly

Sponsor
Fooyin University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03808831
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fall detection and prevention system
  • Device: Sham fall detection and prevention system
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly
Actual Study Start Date :
Jan 20, 2019
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental groups

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
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.

Sham Comparator: Sham group

In the sham group, subjects wear a sham system with record but no alert function.

Device: Sham fall detection and prevention system
The sham system with record but no alert function

Outcome Measures

Primary Outcome Measures

  1. Changes in numbers of falls [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

  2. Changes in numbers of falls [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

  3. Changes in numbers of near-falls [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

  4. Changes in numbers of near-falls [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

  5. Changes in scores of Fall Efficacy Scale - International [Change from baseline scores at 6 weeks]

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

Secondary Outcome Measures

  1. 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

  2. Changes in time (second) to perform timed up and go test [Change from baseline time at 6 weeks]

    Longer time represents a worse outcome

  3. Changes in scores of Berg Balance Scale [Change from baseline scores at 6 weeks]

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

  4. Changes of walking speed (cm/s) [Change from baseline speed at 6 weeks]

    The speed at which participants choose to walk

  5. Changes in scores of Functional Gait Assessment [Change from baseline scores at 6 weeks]

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

  6. Changes in scores of Physical Activity Scale for the Elderly [Change from baseline scores at 6 weeks]

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

  7. Changes is scores of Short-Form-12 Health Survey [Change from baseline scores at 6 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Veterans General Hospital Kaohsiung Taiwan

Sponsors and Collaborators

  • Fooyin University

Investigators

  • Principal Investigator: I-Hsuan Chen, PhD, Department of Physical therapy, Fooyin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
I-Hsuan Chen, Assistant professor, Fooyin University
ClinicalTrials.gov Identifier:
NCT03808831
Other Study ID Numbers:
  • VGHKS18-CT6-13
First Posted:
Jan 18, 2019
Last Update Posted:
Feb 18, 2019
Last Verified:
Feb 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by I-Hsuan Chen, Assistant professor, Fooyin University

Study Results

No Results Posted as of Feb 18, 2019