<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/NCT04494906</url>
  </required_header>
  <id_info>
    <org_study_id>YM109104F</org_study_id>
    <nct_id>NCT04494906</nct_id>
  </id_info>
  <brief_title>Interactive Stepping Exercise on Balance and Cognitive Function</brief_title>
  <official_title>Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson's Disease</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 interactive stepping exercise on&#xD;
      balance and cognitive function in individuals with PD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 19, 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>Romberg test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate static balance ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sharpened Romberg test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate static balance ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>One-leg stance test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate static balance ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate functional walking ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini-Balance Evaluation Systems Test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate balance ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment Chinese version</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate global cognitive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Digit span test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate executive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroop color and word test Chinese version</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate executive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail-making test Chinese version</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate executive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial span test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate visuospatial ability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10-meter walk test</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate walking ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Questionnaire 39</measure>
    <time_frame>Change from baseline at 8 weeks and 12 weeks</time_frame>
    <description>To evaluate the quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Interactive stepping exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Square stepping exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interactive stepping exercise</intervention_name>
    <description>An exercise intervention based on the principle of square stepping exercise</description>
    <arm_group_label>Interactive stepping exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Square stepping exercise</intervention_name>
    <description>Square stepping exercise</description>
    <arm_group_label>Square stepping exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic PD&#xD;
&#xD;
          -  Hoehn &amp; Yahr stage between 1 to 3&#xD;
&#xD;
          -  Age between 50 to 85&#xD;
&#xD;
          -  Stable pharmacologic treatment for the last 2 weeks&#xD;
&#xD;
          -  Ability to walk 10 meters unassisted or with assistive devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other neurological disorders diagnosis than PD&#xD;
&#xD;
          -  Receiving any neurological surgeries&#xD;
&#xD;
          -  Any musculoskeletal disorder or cardiopulmonary disease that may influence&#xD;
             participation in the study&#xD;
&#xD;
          -  The Mini-Mental State Examination (MMSE) &lt; 24 scores&#xD;
&#xD;
          -  Participated in other exercise intervention of study in the past 3 months&#xD;
&#xD;
          -  Colorblindness or color vision deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yea-Ru Yang, PhD</last_name>
    <phone>+886-2-28267279</phone>
    <email>yryang@ym.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yea-Ru Yang, PhD</last_name>
      <phone>886-2-28267279</phone>
      <email>yryang@ym.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 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>Interactive stepping exercise</keyword>
  <keyword>Square stepping exercise</keyword>
  <keyword>Parkinson's disease</keyword>
  <keyword>Balance ability</keyword>
  <keyword>Cognitive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT04494906
org study id: YM109104F
nct id: NCT04494906
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the effects of interactive stepping exercise on
      balance and cognitive function in individuals with PD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Romberg test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate static balance ability
measure: Sharpened Romberg test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate static balance ability
measure: One-leg stance test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate static balance ability
measure: Timed up and go test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate functional walking ability
measure: Mini-Balance Evaluation Systems Test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate balance ability
measure: Montreal Cognitive Assessment Chinese version
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate global cognitive function
measure: Digit span test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate executive function
measure: Stroop color and word test Chinese version
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate executive function
measure: Trail-making test Chinese version
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate executive function
measure: Spatial span test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate visuospatial ability
measure: 10-meter walk test
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate walking ability
measure: Parkinson's Disease Questionnaire 39
time frame: Change from baseline at 8 weeks and 12 weeks
description: To evaluate the quality of life
arm group label: Interactive stepping exercise group
arm group type: Experimental
description: Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).
arm group label: Square stepping exercise group
arm group type: Active Comparator
description: Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).
intervention type: Other
intervention name: Interactive stepping exercise
description: An exercise intervention based on the principle of square stepping exercise
arm group label: Interactive stepping exercise group
intervention type: Other
intervention name: Square stepping exercise
description: Square stepping exercise
arm group label: Square stepping exercise group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yea-Ru Yang, PhD
phone: +886-2-28267279
email: yryang@ym.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Yea-Ru Yang
investigator title: Professor
mesh term: Parkinson Disease