<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/NCT02995486</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-15-0442</org_study_id>
    <nct_id>NCT02995486</nct_id>
  </id_info>
  <brief_title>Effects of a Falls Prevention Program Following Hospital Discharge</brief_title>
  <official_title>Effects of a Falls Prevention Program Following Hospital Discharge From a Neuroscience Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baptist Health South Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida International University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, control trial will be conducted to evaluate the effects of a post-discharge&#xD;
      falls prevention program in patients with neurological diseases and disorders. The objective&#xD;
      of this study is to evaluate if implementing a falls prevention program is effective in&#xD;
      reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance&#xD;
      in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center&#xD;
      will be randomized on the day of discharge to receive an exercise falls prevention program,&#xD;
      delivered by Baptist Health physical therapists, or an educational pamphlet on falls&#xD;
      prevention. Baseline and follow up assessments for gait, balance, and strength will be&#xD;
      completed at regular intervals to examine effects of the exercise program. In addition,&#xD;
      participants will be surveyed to find out about recent falls and hospitalizations. This is a&#xD;
      minimal risk study such that the assessments involve conditions in which subjects likely&#xD;
      encounter on a daily basis. The risks of the exercise intervention also are no more than one&#xD;
      might expect from a community exercise program. Potential benefits include reduced&#xD;
      hospitalizations and/or emergency visits related to falls in the intervention group,&#xD;
      increased activity levels and improved falls efficacy in the intervention group, and&#xD;
      increased system capacity at Baptist Health to deliver a falls prevention program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the consent form, eligible participants will complete a health-related&#xD;
      questionnaire and undergo a gait, balance and strength testing at the time of discharge and&#xD;
      then be randomly referred to an intervention (n=30) or to a control group (n=30).&#xD;
      Participants will be recruited until the target sample (n=60) is reached. Randomization will&#xD;
      be by coin flip.&#xD;
&#xD;
      Measures (intervention and control groups): The evaluation involves non-invasive assessments&#xD;
      of physical functioning conducted by physical therapists including balance, gait, and lower&#xD;
      limb strength testing. Both groups will be tested by physical therapists at baseline 3, and 6&#xD;
      months post-discharge. A 12-month follow-up call will be made to all participants to ask&#xD;
      about falls and physical activity. The physical therapists that conduct the testing will be&#xD;
      different from the physical therapists that deliver the intervention (Otago Exercise&#xD;
      Program). All tests will be completed in 60-90 minute sessions at Baptist Outpatient&#xD;
      Rehabilitation Center. The participants will complete a questionnaire including information&#xD;
      on health and falls history, falls self-efficacy (Falls Efficacy Scale), hospitalizations,&#xD;
      doctors' visits, and emergency department visits. The participants will also complete a&#xD;
      physical assessment including gait analysis using an instrumented mat (GaitRite) to collect&#xD;
      data on the temporo-spatial parameters of gait during preferred gait speed and gait during&#xD;
      street crossing simulation with regular time: 7 seconds. Street crossing regular time&#xD;
      allowance was calculated based on the pre-programmed pedestrian street signals, which give&#xD;
      pedestrians 20 seconds to cross a four-lane street. The GaitRite is a thin mat with pressure&#xD;
      sensors; an integrated software and web-cam that measures and calculates the gait&#xD;
      temporo-spatial parameters. The videos are used only as a visual reference to inspect the&#xD;
      task for quality control during data collection and review and will not be used in the&#xD;
      analysis or in any other way. The physical assessment will also include the BalanceMaster&#xD;
      (Natus Medical, Inc.), a fixed force plate to measure the vertical forces exerted through the&#xD;
      feet to measure center of gravity position and postural control, Tinneti Balance Assessment,&#xD;
      lower limb strength testing using the 30-second chair stand test, and the Timed Up and Go&#xD;
      (TUG) assessment for mobility testing.&#xD;
&#xD;
      Procedures (intervention and control groups): The participants will complete the gait,&#xD;
      balance and chair-rise tests in random order. They will be asked a priori to wear non-slip&#xD;
      socks provided by the research team. During the preferred gait speed condition, the&#xD;
      participants will be instructed to walk on the GAITRite® at their preferred speed as they&#xD;
      usually do during their daily activities. During the simulated street crossing condition, the&#xD;
      participants will be instructed to cross the street when the pedestrian lights turn green and&#xD;
      complete the crossing within the time allowed as displayed by the pedestrian lights on the&#xD;
      video. The video includes audio of traffic noise for a more realistic road crossing&#xD;
      environment, and it displays an intersection situation in which the subject will be&#xD;
      positioned at the intersection, on the sidewalk looking at the oncoming motor vehicle traffic&#xD;
      from both directions. A pedestrian light with countdown will also be displayed on the screen.&#xD;
      Thus, a functional dual-task paradigm will be used including visual cues and the participants&#xD;
      will have to interpret those cues and adjust their gait accordingly. A familiarization trial&#xD;
      will be completed, followed by three recording trials under each condition. The order of gait&#xD;
      conditions will be randomized for each participant. Participants are free to stop&#xD;
      participating at anytime without needing to provide a reason.&#xD;
&#xD;
      Exercise Intervention (intervention group only): The intervention is a comprehensive program&#xD;
      addressing aging-related functional decline, fear of falling and inactivity. It targets&#xD;
      adults with a history of falls or at-risk for falls. Following the assessments, the&#xD;
      participants will be assigned to a control group who will receive the standard educational&#xD;
      information on falls prevention, or to an individualized exercise program prescribed and&#xD;
      delivered by physical therapists (Otago Exercise Program for Falls Prevention). The program&#xD;
      is an easy-to-implement and affordable exercise program for individuals with high risk for&#xD;
      falls. The program design model is person-centered and customized to the individual needs. It&#xD;
      includes a set of leg muscle strengthening and balance retraining exercises, and a walking&#xD;
      plan. Subjects will go to Baptist Outpatient Rehabilitation Center before discharge for the&#xD;
      baseline assessment and exercise prescription, then biweekly during the first 2 months (4&#xD;
      times) for exercise progressions and follow ups, once at month 3 for the first re-assessment,&#xD;
      then again at 6 months for a booster session and second re-assessment. At 12 months a phone&#xD;
      call follow up will be done to ask about falls and physical activity. The assessments and&#xD;
      sessions will be covered by the Baptist Health Neuroscience Center and Rehabilitation&#xD;
      Services. As part of the program, the participants will do 30 minutes of exercise three times&#xD;
      per week, and walk continuously or not for 30 minutes at least two times per week for six&#xD;
      months. Participants record (physical activity log) the days they exercise and walk and&#xD;
      provide the information to the physical therapists during subsequent visits and/or calls.&#xD;
&#xD;
      Physical therapists will prescribe the exercises based on a large selection available on the&#xD;
      program manual. The participants receive an illustration with explanations of the exercises&#xD;
      they need to do. They receive a booklet with exercise instructions and ankle cuff weights.&#xD;
      The physical therapists will do exercise progressions by increasing intensity and/or&#xD;
      difficulty during the subsequent client visits to Baptist Outpatient Rehabilitation Center.&#xD;
      The program also includes monthly telephone calls from study staff to maintain motivation,&#xD;
      collect information on any falls, and answer questions between visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported subsequent falls</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of re-hospitalizations</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait velocity in cm/s from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength in N using a Jamar</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tinneti Balance Assessment scores</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale scores</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Velocity of center of pressure osculation on the balance master</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dorsiflexion strength in N using a hand held dynamometer</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step length in cm from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cadence in steps/minute from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step time in seconds from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swing time in seconds from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stance time in seconds from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double-support time in seconds from a GaitRite instrumented mat</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Accidental Fall</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care with only an educational pamphlet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post-discharge exercise group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Otago Exercise Program for falls prevention after discharge due to fall-related injuries.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Discharged from the hospital after being treated for a fall-related injury;&#xD;
&#xD;
          -  Able to engage in an exercise program for falls prevention (sufficient physical and&#xD;
             cognitive health);&#xD;
&#xD;
          -  Competent to provide consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wheelchair bound;&#xD;
&#xD;
          -  Has contraindications for engaging in an exercise program based on the patient&#xD;
             records;&#xD;
&#xD;
          -  Does not pass the Mini Cog test (brief cognitive screening tool)&#xD;
&#xD;
          -  Does not have reliable transportation for follow-up visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edgar R Vieira</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02995486
org study id: IRB-15-0442
nct id: NCT02995486
lead sponsor: 
collaborator: 
has dmc: No
A randomized, control trial will be conducted to evaluate the effects of a post-discharge
      falls prevention program in patients with neurological diseases and disorders. The objective
      of this study is to evaluate if implementing a falls prevention program is effective in
      reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance
      in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center
      will be randomized on the day of discharge to receive an exercise falls prevention program,
      delivered by Baptist Health physical therapists, or an educational pamphlet on falls
      prevention. Baseline and follow up assessments for gait, balance, and strength will be
      completed at regular intervals to examine effects of the exercise program. In addition,
      participants will be surveyed to find out about recent falls and hospitalizations. This is a
      minimal risk study such that the assessments involve conditions in which subjects likely
      encounter on a daily basis. The risks of the exercise intervention also are no more than one
      might expect from a community exercise program. Potential benefits include reduced
      hospitalizations and/or emergency visits related to falls in the intervention group,
      increased activity levels and improved falls efficacy in the intervention group, and
      increased system capacity at Baptist Health to deliver a falls prevention program.
After signing the consent form, eligible participants will complete a health-related
      questionnaire and undergo a gait, balance and strength testing at the time of discharge and
      then be randomly referred to an intervention (n=30) or to a control group (n=30).
      Participants will be recruited until the target sample (n=60) is reached. Randomization will
      be by coin flip.

      Measures (intervention and control groups): The evaluation involves non-invasive assessments
      of physical functioning conducted by physical therapists including balance, gait, and lower
      limb strength testing. Both groups will be tested by physical therapists at baseline 3, and 6
      months post-discharge. A 12-month follow-up call will be made to all participants to ask
      about falls and physical activity. The physical therapists that conduct the testing will be
      different from the physical therapists that deliver the intervention (Otago Exercise
      Program). All tests will be completed in 60-90 minute sessions at Baptist Outpatient
      Rehabilitation Center. The participants will complete a questionnaire including information
      on health and falls history, falls self-efficacy (Falls Efficacy Scale), hospitalizations,
      doctors' visits, and emergency department visits. The participants will also complete a
      physical assessment including gait analysis using an instrumented mat (GaitRite) to collect
      data on the temporo-spatial parameters of gait during preferred gait speed and gait during
      street crossing simulation with regular time: 7 seconds. Street crossing regular time
      allowance was calculated based on the pre-programmed pedestrian street signals, which give
      pedestrians 20 seconds to cross a four-lane street. The GaitRite is a thin mat with pressure
      sensors; an integrated software and web-cam that measures and calculates the gait
      temporo-spatial parameters. The videos are used only as a visual reference to inspect the
      task for quality control during data collection and review and will not be used in the
      analysis or in any other way. The physical assessment will also include the BalanceMaster
      (Natus Medical, Inc.), a fixed force plate to measure the vertical forces exerted through the
      feet to measure center of gravity position and postural control, Tinneti Balance Assessment,
      lower limb strength testing using the 30-second chair stand test, and the Timed Up and Go
      (TUG) assessment for mobility testing.

      Procedures (intervention and control groups): The participants will complete the gait,
      balance and chair-rise tests in random order. They will be asked a priori to wear non-slip
      socks provided by the research team. During the preferred gait speed condition, the
      participants will be instructed to walk on the GAITRite® at their preferred speed as they
      usually do during their daily activities. During the simulated street crossing condition, the
      participants will be instructed to cross the street when the pedestrian lights turn green and
      complete the crossing within the time allowed as displayed by the pedestrian lights on the
      video. The video includes audio of traffic noise for a more realistic road crossing
      environment, and it displays an intersection situation in which the subject will be
      positioned at the intersection, on the sidewalk looking at the oncoming motor vehicle traffic
      from both directions. A pedestrian light with countdown will also be displayed on the screen.
      Thus, a functional dual-task paradigm will be used including visual cues and the participants
      will have to interpret those cues and adjust their gait accordingly. A familiarization trial
      will be completed, followed by three recording trials under each condition. The order of gait
      conditions will be randomized for each participant. Participants are free to stop
      participating at anytime without needing to provide a reason.

      Exercise Intervention (intervention group only): The intervention is a comprehensive program
      addressing aging-related functional decline, fear of falling and inactivity. It targets
      adults with a history of falls or at-risk for falls. Following the assessments, the
      participants will be assigned to a control group who will receive the standard educational
      information on falls prevention, or to an individualized exercise program prescribed and
      delivered by physical therapists (Otago Exercise Program for Falls Prevention). The program
      is an easy-to-implement and affordable exercise program for individuals with high risk for
      falls. The program design model is person-centered and customized to the individual needs. It
      includes a set of leg muscle strengthening and balance retraining exercises, and a walking
      plan. Subjects will go to Baptist Outpatient Rehabilitation Center before discharge for the
      baseline assessment and exercise prescription, then biweekly during the first 2 months (4
      times) for exercise progressions and follow ups, once at month 3 for the first re-assessment,
      then again at 6 months for a booster session and second re-assessment. At 12 months a phone
      call follow up will be done to ask about falls and physical activity. The assessments and
      sessions will be covered by the Baptist Health Neuroscience Center and Rehabilitation
      Services. As part of the program, the participants will do 30 minutes of exercise three times
      per week, and walk continuously or not for 30 minutes at least two times per week for six
      months. Participants record (physical activity log) the days they exercise and walk and
      provide the information to the physical therapists during subsequent visits and/or calls.

      Physical therapists will prescribe the exercises based on a large selection available on the
      program manual. The participants receive an illustration with explanations of the exercises
      they need to do. They receive a booklet with exercise instructions and ankle cuff weights.
      The physical therapists will do exercise progressions by increasing intensity and/or
      difficulty during the subsequent client visits to Baptist Outpatient Rehabilitation Center.
      The program also includes monthly telephone calls from study staff to maintain motivation,
      collect information on any falls, and answer questions between visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Self-reported subsequent falls
time frame: 12 months
measure: Number of re-hospitalizations
time frame: 12 months
measure: Gait velocity in cm/s from a GaitRite instrumented mat
time frame: 12 months
measure: Grip strength in N using a Jamar
time frame: 12 months
measure: Tinneti Balance Assessment scores
time frame: 12 months
measure: Falls Efficacy Scale scores
time frame: 12 months
measure: Velocity of center of pressure osculation on the balance master
time frame: 12 months
measure: Dorsiflexion strength in N using a hand held dynamometer
time frame: 12 months
measure: Step length in cm from a GaitRite instrumented mat
time frame: 12 months
measure: Cadence in steps/minute from a GaitRite instrumented mat
time frame: 12 months
measure: Step time in seconds from a GaitRite instrumented mat
time frame: 12 months
measure: Swing time in seconds from a GaitRite instrumented mat
time frame: 12 months
measure: Stance time in seconds from a GaitRite instrumented mat
time frame: 12 months
measure: Double-support time in seconds from a GaitRite instrumented mat
time frame: 12 months
arm group label: Control
arm group type: No Intervention
description: Standard care with only an educational pamphlet.
arm group label: Intervention
arm group type: Experimental
description: Post-discharge exercise group
intervention type: Other
intervention name: Exercise
description: Otago Exercise Program for falls prevention after discharge due to fall-related injuries.
arm group label: Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Edgar R Vieira
role: Principal Investigator
affiliation: Florida International University
facility: 
country: United States
responsible party type: Sponsor