<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/NCT04438343</url>
  </required_header>
  <id_info>
    <org_study_id>YM109070F</org_study_id>
    <nct_id>NCT04438343</nct_id>
  </id_info>
  <brief_title>Impairment-Specific and Augmented Intervention on Turning</brief_title>
  <official_title>Effects of Impairment-Specific and Augmented Intervention on Turning Performance 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>
      The objective of this study is to investigate the effects of the impairment-specific and&#xD;
      augmented intervention based balance and strength training on turning performance in&#xD;
      individuals with chronic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Turning performance</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
    <description>Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
    <description>Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
    <description>Using handheld dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Straight walking performance</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
    <description>Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale International (Chinese)</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS) Taiwan version</measure>
    <time_frame>Change from baseline at 4 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Impairment-specific and augmented intervention</intervention_name>
    <description>Balance and lower extremities strength training</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physical therapy</intervention_name>
    <description>Trunk and upper extremity training</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≧ 6 months post first-ever stroke with unilateral motor deficits&#xD;
&#xD;
          -  ≧20 years of age&#xD;
&#xD;
          -  The ability to walk independently for at least 7 m with or without using walking aids&#xD;
&#xD;
          -  Score ≧ 24 of 30 on the Mini-Mental State Examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or&#xD;
             superimposed sepsis)&#xD;
&#xD;
          -  History of other diseases known to interfere with participation in the study (e.g.,&#xD;
             heart failure, hemineglect, or diabetic neuropathy)&#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>Yea-Ru Yang</last_name>
    <phone>+886228267279</phone>
    <email>yryang@nycu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yea-Ru Yang</name>
      <address>
        <city>Taipei</city>
        <state>Beitou</state>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yea-Ru Yang</last_name>
      <phone>+886228267279</phone>
      <email>yryang@nycu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Yea-Ru Yang, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</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>
  <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/NCT04438343
org study id: YM109070F
nct id: NCT04438343
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the effects of the impairment-specific and
      augmented intervention based balance and strength training on turning performance in
      individuals with chronic stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Turning performance
time frame: Change from baseline at 4 week
description: Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
measure: Balance
time frame: Change from baseline at 4 week
description: Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
measure: Strength
time frame: Change from baseline at 4 week
description: Using handheld dynamometer
measure: Straight walking performance
time frame: Change from baseline at 4 week
description: Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length
measure: Timed up and go test
time frame: Change from baseline at 4 week
measure: Falls Efficacy Scale International (Chinese)
time frame: Change from baseline at 4 week
measure: Stroke Impact Scale (SIS) Taiwan version
time frame: Change from baseline at 4 week
arm group label: experimental group
arm group type: Experimental
arm group label: control group
arm group type: Active Comparator
intervention type: Other
intervention name: Impairment-specific and augmented intervention
description: Balance and lower extremities strength training
arm group label: experimental group
intervention type: Other
intervention name: Conventional physical therapy
description: Trunk and upper extremity training
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yea-Ru Yang
phone: +886228267279
email: yryang@nycu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Yea-Ru Yang
investigator title: Professor
mesh term: Stroke