<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/NCT04441541</url>
  </required_header>
  <id_info>
    <org_study_id>YM109073F</org_study_id>
    <nct_id>NCT04441541</nct_id>
  </id_info>
  <brief_title>Treadmill With Biofeedback on Gait Symmetry After Stroke</brief_title>
  <official_title>The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming 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>
      This study aims to investigate the immediate, accumulated, and maintainable effects of&#xD;
      treadmill with biofeedback on gait symmetry in individuals with chronic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spatial and temporal gait symmetry</measure>
    <time_frame>Change from baseline at the first day, 4 weeks, and 8 weeks</time_frame>
    <description>Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Change from baseline at the first day, 4 weeks, and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Test</measure>
    <time_frame>Change from baseline at the first day, 4 weeks, and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and Go test</measure>
    <time_frame>Change from baseline at the first day, 4 weeks, and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>Change from baseline at the first day, 4 weeks, and 8 weeks</time_frame>
    <description>quality of life</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Stroke Syndrome</condition>
  <arm_group>
    <arm_group_label>Treadmill with auditory feedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill with visual feedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill with auditory and visual feedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill with auditory feedback</intervention_name>
    <description>Participants will receive training 3 times per week for 4 weeks (12 sessions).</description>
    <arm_group_label>Treadmill with auditory feedback group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill with visual feedback</intervention_name>
    <description>Participants will receive training 3 times per week for 4 weeks (12 sessions).</description>
    <arm_group_label>Treadmill with visual feedback group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill with auditory and visual feedback</intervention_name>
    <description>Participants will receive training 3 times per week for 4 weeks (12 sessions).</description>
    <arm_group_label>Treadmill with auditory and visual feedback group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill training</intervention_name>
    <description>Participants will receive training 3 times per week for 4 weeks (12 sessions).</description>
    <arm_group_label>Treadmill training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single stroke experience&#xD;
&#xD;
          -  Chronic stroke phase: stroke duration ≥ 6 months&#xD;
&#xD;
          -  Independent gait: Functional Ambulation Category (FAC) ≥ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive problem (MMSE &lt; 24)&#xD;
&#xD;
          -  Visual or audio deficiency that might affect training&#xD;
&#xD;
          -  Severe heart insufficiency or uncontrolled arterial hypertension&#xD;
&#xD;
          -  Orthopedic disorders that affecting their gait&#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_contact>
    <last_name>Yang Yea-Ru, PhD</last_name>
    <phone>2826-7279</phone>
    <email>yryang@ym.edu.tw</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Yea-Ru Yang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gait training</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Treadmill</keyword>
  <keyword>Gait symmetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04441541
org study id: YM109073F
nct id: NCT04441541
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the immediate, accumulated, and maintainable effects of
      treadmill with biofeedback on gait symmetry in individuals with chronic stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Spatial and temporal gait symmetry
time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
description: Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)
measure: Walking speed
time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: 6 Minute Walk Test
time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: Timed up and Go test
time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
measure: Stroke Impact Scale
time frame: Change from baseline at the first day, 4 weeks, and 8 weeks
description: quality of life
arm group label: Treadmill with auditory feedback group
arm group type: Experimental
arm group label: Treadmill with visual feedback group
arm group type: Experimental
arm group label: Treadmill with auditory and visual feedback group
arm group type: Experimental
arm group label: Treadmill training group
arm group type: Active Comparator
intervention type: Other
intervention name: Treadmill with auditory feedback
description: Participants will receive training 3 times per week for 4 weeks (12 sessions).
arm group label: Treadmill with auditory feedback group
intervention type: Other
intervention name: Treadmill with visual feedback
description: Participants will receive training 3 times per week for 4 weeks (12 sessions).
arm group label: Treadmill with visual feedback group
intervention type: Other
intervention name: Treadmill with auditory and visual feedback
description: Participants will receive training 3 times per week for 4 weeks (12 sessions).
arm group label: Treadmill with auditory and visual feedback group
intervention type: Other
intervention name: Treadmill training
description: Participants will receive training 3 times per week for 4 weeks (12 sessions).
arm group label: Treadmill training group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yang Yea-Ru, PhD
phone: 2826-7279
email: yryang@ym.edu.tw
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Yea-Ru Yang
investigator title: Professor
mesh term: Stroke