<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/NCT01690611</url>
  </required_header>
  <id_info>
    <org_study_id>366151-1</org_study_id>
    <nct_id>NCT01690611</nct_id>
  </id_info>
  <brief_title>Visual Feedback to Improve Balance During Walking</brief_title>
  <official_title>Sensory Treadmill to Improve of Balance During Walking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to determine if real time visual feedback of body movements&#xD;
      improves balance control more than walking on a treadmill alone. Individuals participating in&#xD;
      this research study will be tested using a battery of clinical strength and balance&#xD;
      assessments twice before a 4 week training period and once after the training period. The 4&#xD;
      week training period will consist of 12 sessions walking on a treadmill. The experimental&#xD;
      group will see real time visual feedback regarding their body movements, and the control&#xD;
      group will not receive this visual feedback. Following the 4 week training each participant&#xD;
      will again be tested using the battery of clinical strength and balance assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in BESTest Score, A clinical assessment of balance</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
    <description>Balance Evaluation System Test (BESTest)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Berg Balance Test Score</measure>
    <time_frame>Test will be given at 0, 4, and 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Activity Specific Balance Confidence Score</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
    <description>Questionnaire rating balance confidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in 6 Minute Walk Test</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Comfortable Walking Speed</measure>
    <time_frame>Measured daily, up to 12 days</time_frame>
    <description>This value is determined for each training session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Muscle Strength</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
    <description>Strength of major muscles in the legs and trunk will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Overground Walking Speed</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Center of Mass variability</measure>
    <time_frame>Tested daily, up to 12 days</time_frame>
    <description>This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Power spectral density</measure>
    <time_frame>Tested daily, up to 12 days</time_frame>
    <description>This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Single/Dual Tasking ability</measure>
    <time_frame>Tested at 0, 4, and 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Other Fall</condition>
  <condition>Patient Falls</condition>
  <arm_group>
    <arm_group_label>Walking &amp; Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals in this arm will walk on a treadmill while viewing real time visual feedback regarding their body motions and use the visual feedback to correct their body motions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking &amp; No Visual Feedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals in this arm will walk on a treadmill without viewing real time visual feedback regarding their body motion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treadmill Walking</intervention_name>
    <description>Individuals will walk at a &quot;comfortable speed&quot; on a treadmill without holding on to the hand rails.</description>
    <arm_group_label>Walking &amp; No Visual Feedback</arm_group_label>
    <arm_group_label>Walking &amp; Visual Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visual Feedback</intervention_name>
    <description>Real time feedback regarding body motion while walking.</description>
    <arm_group_label>Walking &amp; Visual Feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fall Prone Older Adults (history of falls or loss of balance)&#xD;
&#xD;
          -  ability to walk on the treadmill hands-free without assistance&#xD;
&#xD;
          -  Mini-Mental Status Exam &gt; 23&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current enrollment in physical rehabilitation of any kind&#xD;
&#xD;
          -  Medically unstable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Jeka, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Collington Episcopal Life Care Community</name>
      <address>
        <city>Mitchellville</city>
        <state>Maryland</state>
        <zip>20721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pearson Hall, Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>April 19, 2016</last_update_submitted>
  <last_update_submitted_qc>April 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Temple University</investigator_affiliation>
    <investigator_full_name>John Jeka</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Balance Training</keyword>
  <keyword>Walking</keyword>
  <keyword>Falls</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/NCT01690611
org study id: 366151-1
nct id: NCT01690611
lead sponsor: 
collaborator: 
has dmc: No
The goal of this research is to determine if real time visual feedback of body movements
      improves balance control more than walking on a treadmill alone. Individuals participating in
      this research study will be tested using a battery of clinical strength and balance
      assessments twice before a 4 week training period and once after the training period. The 4
      week training period will consist of 12 sessions walking on a treadmill. The experimental
      group will see real time visual feedback regarding their body movements, and the control
      group will not receive this visual feedback. Following the 4 week training each participant
      will again be tested using the battery of clinical strength and balance assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Baseline in BESTest Score, A clinical assessment of balance
time frame: Tested at 0, 4, and 8 weeks
description: Balance Evaluation System Test (BESTest)
measure: Change from Baseline in Berg Balance Test Score
time frame: Test will be given at 0, 4, and 8 weeks
measure: Change from Baseline in Activity Specific Balance Confidence Score
time frame: Tested at 0, 4, and 8 weeks
description: Questionnaire rating balance confidence
measure: Change from Baseline in 6 Minute Walk Test
time frame: Tested at 0, 4, and 8 weeks
measure: Change from Baseline in Comfortable Walking Speed
time frame: Measured daily, up to 12 days
description: This value is determined for each training session
measure: Change from Baseline in Muscle Strength
time frame: Tested at 0, 4, and 8 weeks
description: Strength of major muscles in the legs and trunk will be measured
measure: Change from Baseline in Overground Walking Speed
time frame: Tested at 0, 4, and 8 weeks
measure: Change from Baseline in Center of Mass variability
time frame: Tested daily, up to 12 days
description: This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.
measure: Change from Baseline in Power spectral density
time frame: Tested daily, up to 12 days
description: This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.
measure: Change from Baseline in Single/Dual Tasking ability
time frame: Tested at 0, 4, and 8 weeks
arm group label: Walking & Visual Feedback
arm group type: Experimental
description: Individuals in this arm will walk on a treadmill while viewing real time visual feedback regarding their body motions and use the visual feedback to correct their body motions.
arm group label: Walking & No Visual Feedback
arm group type: Active Comparator
description: Individuals in this arm will walk on a treadmill without viewing real time visual feedback regarding their body motion.
intervention type: Procedure
intervention name: Treadmill Walking
description: Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.
arm group label: Walking & No Visual Feedback
arm group label: Walking & Visual Feedback
intervention type: Other
intervention name: Visual Feedback
description: Real time feedback regarding body motion while walking.
arm group label: Walking & Visual Feedback
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: John Jeka, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Temple University
investigator full name: John Jeka
investigator title: Professor