<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/NCT02207933</url>
  </required_header>
  <id_info>
    <org_study_id>4-2013-0270</org_study_id>
    <nct_id>NCT02207933</nct_id>
  </id_info>
  <brief_title>Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of anteroposterior weight shifting training with visual biofeedback&#xD;
      on step length asymmetry. Reduced speed and asymmetry of stepping is a specific&#xD;
      characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step&#xD;
      length of the unaffected limb compared to the affected limb. Causes of this phenomenon are&#xD;
      difficulty in weight bearing at the affected limb, weak propulsive force of the affected&#xD;
      limb, and decreased strength of hip extensors. To correct these factors. we have developed an&#xD;
      anteroposterior weight shifting training system with visual feedback and studied its effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of step Length Asymmetric Ratio</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 12 weeks</time_frame>
    <description>paretic step length/non paretic step length</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of Step Length Asymmetric Index</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 12 weeks</time_frame>
    <description>paretic step length-non paretic step length/0.5[paretic step length +non paretic step length</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiplegic Gait</condition>
  <arm_group>
    <arm_group_label>AP shifting group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>gait training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AP shifting training</intervention_name>
    <description>AP shifting training in addition to gait training 3 times a week for 6 weeks</description>
    <arm_group_label>AP shifting group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gait training</intervention_name>
    <description>Gait training only for 3 times a week for 6 weeks.</description>
    <arm_group_label>gait training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Independent standing&#xD;
&#xD;
          2. Ability to walk 10m without manual assistance&#xD;
&#xD;
          3. Asymmetric ratio of step length &gt; 1.1&#xD;
&#xD;
          4. No severe perceptual, cognitive or cardiovascular impairments that could affect&#xD;
             walking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Quadriplegia or double hemiplegia&#xD;
&#xD;
          2. Orthopedic or neurologic conditions in addition to the stroke&#xD;
&#xD;
          3. Had more than 1 cerebrovascular accident&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deog Young Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anterioposterior</keyword>
  <keyword>weight</keyword>
  <keyword>shifting</keyword>
  <keyword>training</keyword>
  <keyword>patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02207933
org study id: 4-2013-0270
nct id: NCT02207933
lead sponsor: 
has dmc: No
To investigate the effect of anteroposterior weight shifting training with visual biofeedback
      on step length asymmetry. Reduced speed and asymmetry of stepping is a specific
      characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step
      length of the unaffected limb compared to the affected limb. Causes of this phenomenon are
      difficulty in weight bearing at the affected limb, weak propulsive force of the affected
      limb, and decreased strength of hip extensors. To correct these factors. we have developed an
      anteroposterior weight shifting training system with visual feedback and studied its effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: change of step Length Asymmetric Ratio
time frame: baseline, 3 weeks, 6 weeks, 12 weeks
description: paretic step length/non paretic step length
measure: change of Step Length Asymmetric Index
time frame: baseline, 3 weeks, 6 weeks, 12 weeks
description: paretic step length-non paretic step length/0.5[paretic step length +non paretic step length
arm group label: AP shifting group
arm group type: Experimental
arm group label: gait training group
arm group type: Active Comparator
intervention type: Procedure
intervention name: AP shifting training
description: AP shifting training in addition to gait training 3 times a week for 6 weeks
arm group label: AP shifting group
intervention type: Procedure
intervention name: Gait training
description: Gait training only for 3 times a week for 6 weeks.
arm group label: gait training group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Deog Young Kim, MD, PhD
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gait Disorders, Neurologic