xml: <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/NCT06000904</url>
    </required_header>
    <id_info>
      <org_study_id>NYCU112118AF</org_study_id>
      <nct_id>NCT06000904</nct_id>
    </id_info>
    <brief_title>Strategy of Turning Performance in Individuals With Stroke</brief_title>
    <official_title>Evaluation and Improving Strategy of Turning Performance in Individuals With 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>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-blind randomized controlled trial study. Thirty individuals with chronic&#xD;
        stroke will be recruited and randomly assigned to the experimental and control groups.&#xD;
        Subjects in the experimental group will receive exergame-based balance training, while&#xD;
        subjects in the control group will receive upper limb and trunk training. Both groups will&#xD;
        undergo a four-week intervention consisting of three sessions per week, each lasting 60&#xD;
        minutes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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 velocity (degrees/second)</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of steps taken during turning</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Turning step length (cm)</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Stance phase duration (%) during turning</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Swing phase duration (%) during turning</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Berg Balance Scale</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
      <description>The Berg Balance Scale is employed to evaluate the functional balance ability of the subjects. This tool comprises 14 individual tests, each scored on a scale from 0 to 4, resulting in a total score of 56. A higher score indicates better balance ability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Limits of stability test</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
      <description>The limits of stability test is used to evaluate the dynamic balance ability of participants. Overall percentage is defined as the amount of direction control accuracy the individual has when performing the test. A higher percentage reflects better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified clinical test of sensory interaction in balance</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
      <description>This test is designed to assess sensory integration ability basing on the conditions of eyes open or closed and stable or unstable ground. The test is conducted in four contexts: context 1 involves standing with eyes open on a firm surface; context 2 involves standing with eyes open on a foam cushion; context 3 involves standing with eyes closed on a firm surface; and context 4 involves standing with eyes closed on a foam cushion. The overall sway index will be recorded for each condition of each trial, which will be summed the average of each condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Walking velocity (cm/sec) in straight walk</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Step length (cm) in straight walk</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cadence (steps/minute) in straight walk</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stance phase duration (%) in straight walk</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Swing phase duration (%) in straight walk</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time Up and Go test</measure>
      <time_frame>Change from baseline at 4 weeks</time_frame>
      <description>The Timed Up &amp; Go (TUG) test is employed to evaluate the activity functionality of participants. The average time taken for completion will be recorded for analysis.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Exergame-based balance training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Upper limb and trunk training group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exergame-based balance training</intervention_name>
      <description>For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute balance exercise, and 15-minute ground walking as a cool-down.</description>
      <arm_group_label>Exergame-based balance training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Upper limb and trunk training</intervention_name>
      <description>For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute upper-limb and trunk exercise, and 15-minute ground walking as a cool-down.</description>
      <arm_group_label>Upper limb and trunk training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged ≥18 years&#xD;
  &#xD;
            -  single incident of stroke&#xD;
  &#xD;
            -  stroke duration of at least 6 months&#xD;
  &#xD;
            -  lower limb Brunnstrom motor recovery stage between level three and five&#xD;
  &#xD;
            -  Functional Ambulation Categories scale ≥3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with cognitive impairmen (the Mini-Mental State Examination with a score&#xD;
               below 24)&#xD;
  &#xD;
            -  visual or auditory impairments&#xD;
  &#xD;
            -  communication disorders&#xD;
  &#xD;
            -  other neurological diseases affecting motor performance, or any orthopedic conditions&#xD;
               that could influence walking ability&#xD;
  &#xD;
            -  contraindications to physical activity, such as angina or uncontrolled hypertension&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University</name>
        <address>
          <city>Taipei</city>
          <zip>112</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Turning performance</keyword>
    <keyword>Balance performance</keyword>
    <keyword>Exergame</keyword>
    <keyword>Balance training</keyword>
    <keyword>Stroke</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000904
  org study id: NYCU112118AF
  nct id: NCT06000904
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-blind randomized controlled trial study. Thirty individuals with chronic
        stroke will be recruited and randomly assigned to the experimental and control groups.
        Subjects in the experimental group will receive exergame-based balance training, while
        subjects in the control group will receive upper limb and trunk training. Both groups will
        undergo a four-week intervention consisting of three sessions per week, each lasting 60
        minutes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Turning velocity (degrees/second)
  time frame: Change from baseline at 4 weeks
  measure: Number of steps taken during turning
  time frame: Change from baseline at 4 weeks
  measure: Turning step length (cm)
  time frame: Change from baseline at 4 weeks
  measure: Stance phase duration (%) during turning
  time frame: Change from baseline at 4 weeks
  measure: Swing phase duration (%) during turning
  time frame: Change from baseline at 4 weeks
  measure: Berg Balance Scale
  time frame: Change from baseline at 4 weeks
  description: The Berg Balance Scale is employed to evaluate the functional balance ability of the subjects. This tool comprises 14 individual tests, each scored on a scale from 0 to 4, resulting in a total score of 56. A higher score indicates better balance ability.
  measure: Limits of stability test
  time frame: Change from baseline at 4 weeks
  description: The limits of stability test is used to evaluate the dynamic balance ability of participants. Overall percentage is defined as the amount of direction control accuracy the individual has when performing the test. A higher percentage reflects better performance.
  measure: Modified clinical test of sensory interaction in balance
  time frame: Change from baseline at 4 weeks
  description: This test is designed to assess sensory integration ability basing on the conditions of eyes open or closed and stable or unstable ground. The test is conducted in four contexts: context 1 involves standing with eyes open on a firm surface; context 2 involves standing with eyes open on a foam cushion; context 3 involves standing with eyes closed on a firm surface; and context 4 involves standing with eyes closed on a foam cushion. The overall sway index will be recorded for each condition of each trial, which will be summed the average of each condition.
  measure: Walking velocity (cm/sec) in straight walk
  time frame: Change from baseline at 4 weeks
  measure: Step length (cm) in straight walk
  time frame: Change from baseline at 4 weeks
  measure: Cadence (steps/minute) in straight walk
  time frame: Change from baseline at 4 weeks
  measure: Stance phase duration (%) in straight walk
  time frame: Change from baseline at 4 weeks
  measure: Swing phase duration (%) in straight walk
  time frame: Change from baseline at 4 weeks
  measure: Time Up and Go test
  time frame: Change from baseline at 4 weeks
  description: The Timed Up & Go (TUG) test is employed to evaluate the activity functionality of participants. The average time taken for completion will be recorded for analysis.
  arm group label: Exergame-based balance training group
  arm group type: Experimental
  arm group label: Upper limb and trunk training group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Exergame-based balance training
  description: For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute balance exercise, and 15-minute ground walking as a cool-down.
  arm group label: Exergame-based balance training group
  intervention type: Other
  intervention name: Upper limb and trunk training
  description: For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute upper-limb and trunk exercise, and 15-minute ground walking as a cool-down.
  arm group label: Upper limb and trunk training group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  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
  sharing ipd: Undecided