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Completed

NCT Number: NCT03808831

Fall Detection and Prevention System for the Elderly

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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Key information

Conditions

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fall detection and prevention system

Device

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 fall detection and prevention system

Device

The sham system with record but no alert function

Primary outcomes

  1. Changes in numbers of falls

    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

  2. Changes in numbers of falls

    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

  3. Changes in numbers of near-falls

    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

  4. Changes in numbers of near-falls

    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

  5. Changes in scores of Fall Efficacy Scale - International

    Time frame: Change from baseline scores at 6 weeks

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

Secondary outcomes

  1. Changes in center of pressures (cm)

    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

  2. Changes in time (second) to perform timed up and go test

    Time frame: Change from baseline time at 6 weeks

    Longer time represents a worse outcome

  3. Changes in scores of Berg Balance Scale

    Time frame: 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)

    Time frame: Change from baseline speed at 6 weeks

    The speed at which participants choose to walk

  5. Changes in scores of Functional Gait Assessment

    Time frame: 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

    Time frame: 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

    Time frame: Change from baseline scores at 6 weeks

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

Sponsors and collaborators

Lead sponsor

Fooyin University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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