<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808831</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS18-CT6-13</org_study_id>
    <nct_id>NCT03808831</nct_id>
  </id_info>
  <brief_title>Fall Detection and Prevention System for the Elderly</brief_title>
  <official_title>Clinical Application of a Fall Detection and Prevention System for Reducing Falls in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fooyin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fooyin University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an urgent need for developing monitoring systems that can detect near-falls and&#xD;
      alert persons who suffer from subsequently falls. Therefore, investigators propose a project&#xD;
      to study the clinical application of a fall detection and prevention system for reducing&#xD;
      falls in the elderly.&#xD;
&#xD;
      The main objectives of the project are to develop the fall detection and prevention system&#xD;
      and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will&#xD;
      be recruited and randomly allocated into either the experimental or sham groups (n=40 for&#xD;
      each group). Subjects in the experimental group will wear the fall detection and prevention&#xD;
      system on the lower back. The system records near-fall and fall events; meanwhile, it alarms&#xD;
      subjects while detecting near-fall events and alarms caregivers while detecting fall events.&#xD;
      In the sham group, subjects wear a sham system with record but no alert function. Both groups&#xD;
      will receive the same treadmill walking training for 30 minutes per session, 3 sessions per&#xD;
      week for 6 weeks. The outcome measures including falls, balance function, gait ability,&#xD;
      physical activity, and quality of life will be assessed before intervention, after&#xD;
      intervention, and at 6-months follow-up.&#xD;
&#xD;
      Fall-induced physiological and psychological consequences limit daily activities and reduce&#xD;
      quality of life in the elderly. The proposed study innovates a system that not only detects&#xD;
      but also alarms users to prevent falls. Moreover, quantitative measurement of such fall&#xD;
      detection and prevention system will be investigated for the elderly in this project. This&#xD;
      study provides practical and efficacy solutions to prevent falls for home and community&#xD;
      settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fall prevention is the most important issue for the elderly. Due to the low cost and&#xD;
      convenience of wearable devices, numerous techniques have been developed to detect falls in&#xD;
      clinical environment. However, such effects with large populations have not been established&#xD;
      for the elderly. Another, existing systems mainly focus on detecting a fall with little&#xD;
      emphasis on fall prediction and prevention. There is an urgent need for developing monitoring&#xD;
      systems that can detect near-falls and alert persons who suffer from subsequently falls.&#xD;
      Therefore, investigators propose a project to study the clinical application of a fall&#xD;
      detection and prevention system for reducing falls in the elderly.&#xD;
&#xD;
      The main objectives of the project are to develop the fall detection and prevention system&#xD;
      and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will&#xD;
      be recruited and randomly allocated into either the experimental or sham groups (n=40 for&#xD;
      each group). Subjects in the experimental group will wear the fall detection and prevention&#xD;
      system on the lower back. The system records near-fall and fall events; meanwhile, it alarms&#xD;
      subjects while detecting near-fall events and alarms caregivers while detecting fall events.&#xD;
      In the sham group, subjects wear a sham system with record but no alert function. Both groups&#xD;
      will receive the same treadmill walking training for 30 minutes per session, 3 sessions per&#xD;
      week for 6 weeks. The outcome measures including falls, balance function, gait ability,&#xD;
      physical activity, and quality of life will be assessed before intervention, after&#xD;
      intervention, and at 6-months follow-up.&#xD;
&#xD;
      Fall-induced physiological and psychological consequences limit daily activities and reduce&#xD;
      quality of life in the elderly. The proposed study innovates a system that not only detects&#xD;
      but also alarms users to prevent falls. Moreover, quantitative measurement of such fall&#xD;
      detection and prevention system will be investigated for the elderly in this project. This&#xD;
      study provides practical and efficacy solutions to prevent falls for home and community&#xD;
      settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in numbers of falls</measure>
    <time_frame>Change from baseline numbers of falls at 6 weeks</time_frame>
    <description>An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in numbers of falls</measure>
    <time_frame>Change from baseline numbers of falls at 6 months</time_frame>
    <description>An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in numbers of near-falls</measure>
    <time_frame>Change from baseline numbers of near-falls at 6 weeks</time_frame>
    <description>A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in numbers of near-falls</measure>
    <time_frame>Change from baseline numbers of near-falls at 6 months</time_frame>
    <description>A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in scores of Fall Efficacy Scale - International</measure>
    <time_frame>Change from baseline scores at 6 weeks</time_frame>
    <description>Higher scores represent greater the fear of falling (ranging from 16 to 64)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in center of pressures (cm)</measure>
    <time_frame>Change from baseline postural sway at 6 weeks</time_frame>
    <description>The point where the total sum of a pressure field acts on a body, causing a force to act through that point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in time (second) to perform timed up and go test</measure>
    <time_frame>Change from baseline time at 6 weeks</time_frame>
    <description>Longer time represents a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in scores of Berg Balance Scale</measure>
    <time_frame>Change from baseline scores at 6 weeks</time_frame>
    <description>Higher values represent a better outcome (ranging from 0 to 56)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of walking speed (cm/s)</measure>
    <time_frame>Change from baseline speed at 6 weeks</time_frame>
    <description>The speed at which participants choose to walk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in scores of Functional Gait Assessment</measure>
    <time_frame>Change from baseline scores at 6 weeks</time_frame>
    <description>Higher values represent a better outcome (ranging from 0 to 30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in scores of Physical Activity Scale for the Elderly</measure>
    <time_frame>Change from baseline scores at 6 weeks</time_frame>
    <description>Higher scores represent a greater physical activity (ranging from 0 to 793)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes is scores of Short-Form-12 Health Survey</measure>
    <time_frame>Change from baseline scores at 6 weeks</time_frame>
    <description>Score &gt; 50 indicate better physical or mental health than the mean</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>Experimental groups</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In the sham group, subjects wear a sham system with record but no alert function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fall detection and prevention system</intervention_name>
    <description>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.</description>
    <arm_group_label>Experimental groups</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham fall detection and prevention system</intervention_name>
    <description>The sham system with record but no alert function</description>
    <arm_group_label>Sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 65 years&#xD;
&#xD;
          -  Able to walk independently for at least 5 m with or without the use of stick, quad&#xD;
             stick or AFO&#xD;
&#xD;
          -  With a history or fear of falls&#xD;
&#xD;
          -  Able to follow the commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With a severe cardiovascular, respiratory, musculoskeletal or neurological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Hsuan Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical therapy, Fooyin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>I-Hsuan Chen, PhD</last_name>
    <phone>+886-929130306</phone>
    <email>Y0894@fy.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Hsuan Chen</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fooyin University</investigator_affiliation>
    <investigator_full_name>I-Hsuan Chen</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Fall detection</keyword>
  <keyword>Fall prevention</keyword>
  <keyword>Accelerometer</keyword>
  <keyword>Elderly</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808831
org study id: VGHKS18-CT6-13
nct id: NCT03808831
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes in numbers of falls
time frame: Change from baseline numbers of falls at 6 weeks
description: An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
measure: Changes in numbers of falls
time frame: Change from baseline numbers of falls at 6 months
description: An event which results in a participant coming to rest inadvertently on the ground or floor or other lower level
measure: Changes in numbers of near-falls
time frame: Change from baseline numbers of near-falls at 6 weeks
description: A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
measure: Changes in numbers of near-falls
time frame: Change from baseline numbers of near-falls at 6 months
description: A stumble event or loss of balance that would result in a fall if sufficient recovery mechanisms were not activated
measure: Changes in scores of Fall Efficacy Scale - International
time frame: Change from baseline scores at 6 weeks
description: Higher scores represent greater the fear of falling (ranging from 16 to 64)
measure: Changes in center of pressures (cm)
time frame: Change from baseline postural sway at 6 weeks
description: The point where the total sum of a pressure field acts on a body, causing a force to act through that point
measure: Changes in time (second) to perform timed up and go test
time frame: Change from baseline time at 6 weeks
description: Longer time represents a worse outcome
measure: Changes in scores of Berg Balance Scale
time frame: Change from baseline scores at 6 weeks
description: Higher values represent a better outcome (ranging from 0 to 56)
measure: Changes of walking speed (cm/s)
time frame: Change from baseline speed at 6 weeks
description: The speed at which participants choose to walk
measure: Changes in scores of Functional Gait Assessment
time frame: Change from baseline scores at 6 weeks
description: Higher values represent a better outcome (ranging from 0 to 30)
measure: Changes in scores of Physical Activity Scale for the Elderly
time frame: Change from baseline scores at 6 weeks
description: Higher scores represent a greater physical activity (ranging from 0 to 793)
measure: Changes is scores of Short-Form-12 Health Survey
time frame: Change from baseline scores at 6 weeks
description: Score > 50 indicate better physical or mental health than the mean
arm group label: Experimental groups
arm group type: Experimental
description: 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.
arm group label: Sham group
arm group type: Sham Comparator
description: In the sham group, subjects wear a sham system with record but no alert function.
intervention type: Device
intervention name: Fall detection and prevention system
description: 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.
arm group label: Experimental groups
intervention type: Device
intervention name: Sham fall detection and prevention system
description: The sham system with record but no alert function
arm group label: Sham group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: I-Hsuan Chen, PhD
role: Principal Investigator
affiliation: Department of Physical therapy, Fooyin University
last name: I-Hsuan Chen, PhD
phone: +886-929130306
email: Y0894@fy.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Fooyin University
investigator full name: I-Hsuan Chen
investigator title: Assistant professor