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/NCT06011018</url>
    </required_header>
    <id_info>
      <org_study_id>KMUHIRB-F(II)-20220175</org_study_id>
      <nct_id>NCT06011018</nct_id>
    </id_info>
    <brief_title>Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke</brief_title>
    <official_title>Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</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 study aims to compare the effects of mirror therapy combined with either neuromuscular&#xD;
        electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function&#xD;
        recovery. The study also explores the relationship between patients' cortical excitability&#xD;
        and motor function improvement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 25, 2022</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</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>
      <intervention_model_description>Participants were randomly assigned treatment groups:&#xD;
  Mirror Therapy&#xD;
  Mirror Therapy + Electrical Stimulation&#xD;
  Mirror Therapy + Binaural Beat</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fugl-Meyer assessment, lower extremity</measure>
      <time_frame>10minutes</time_frame>
      <description>The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Modified ashworth scale</measure>
      <time_frame>5minutes</time_frame>
      <description>The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed up and go test</measure>
      <time_frame>5minutes</time_frame>
      <description>The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The postural assessment scale for stroke patients</measure>
      <time_frame>10 minutes</time_frame>
      <description>Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barthel index</measure>
      <time_frame>5minutes</time_frame>
      <description>The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Electroencephalography</measure>
      <time_frame>20minutes</time_frame>
      <description>Electroencephalography is used obtain power data of total μ (8-12Hz), lower μ (8-10Hz), and upper μ (10-12Hz).&#xD;
  μ suppression→ a negative value (&lt;0) indicates inhibition of μ waves, indicating activation in the motor cortex(Bae et al., 2012).</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Stroke</condition>
    <condition>Healthy Adults</condition>
    <arm_group>
      <arm_group_label>Mirror therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Mirror Therapy + Electrical Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Mirror Therapy + Binaural Beat</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mirror Therapy</intervention_name>
      <description>Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises.&#xD;
  Duration: 5 seconds, Rest: 5 seconds</description>
      <arm_group_label>Mirror therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mirror Therapy + Electrical Stimulation</intervention_name>
      <description>Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.</description>
      <arm_group_label>Mirror Therapy + Electrical Stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mirror Therapy + Binaural Beat</intervention_name>
      <description>Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation</description>
      <arm_group_label>Mirror Therapy + Binaural Beat</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. First occurrence of stroke≧ 6 months&#xD;
  &#xD;
            2. Mini-mental state examination≧24&#xD;
  &#xD;
            3. Modified Ashworth's scale of ankle muscle ≦3&#xD;
  &#xD;
            4. Sit independently≧30 mins&#xD;
  &#xD;
            5. Brunnstrom stage ≧3&#xD;
  &#xD;
            6. Aged between 20 and 80 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Speech impairment&#xD;
  &#xD;
            2. Hearing impairment&#xD;
  &#xD;
            3. Visual impairment&#xD;
  &#xD;
            4. Other orthopedic diseases or nerve damage&#xD;
  &#xD;
            5. Complete sensory impairment&#xD;
  &#xD;
            6. Pacemaker or metal implants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>LIN JAU HONG, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Kaohsiung Medical University,department of Physical Therapy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>LIN JAU HONG, Ph.D.</last_name>
      <phone>0929393300</phone>
      <email>jhlin@kmu.edu.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>LIN YEN YU, Master's degree</last_name>
      <phone>0988392631</phone>
      <email>yenyu.lin88@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kaohsiung Medical University, Department of Physical Therapy</name>
        <address>
          <city>Kaohsiung</city>
          <zip>807</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>LIN JAU HONG, Ph.D.</last_name>
        <phone>0929393300</phone>
        <email>jhlin@kmu.edu.tw</email>
      </contact>
      <contact_backup>
        <last_name>LIN YEN YU, Master's</last_name>
        <phone>0988392631</phone>
        <email>yenyu.lin88@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data</ipd_description>
    </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/NCT06011018
  org study id: KMUHIRB-F(II)-20220175
  nct id: NCT06011018
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare the effects of mirror therapy combined with either neuromuscular
        electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function
        recovery. The study also explores the relationship between patients' cortical excitability
        and motor function improvement.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants were randomly assigned treatment groups:
  Mirror Therapy
  Mirror Therapy + Electrical Stimulation
  Mirror Therapy + Binaural Beat
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Fugl-Meyer assessment, lower extremity
  time frame: 10minutes
  description: The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.
  measure: Modified ashworth scale
  time frame: 5minutes
  description: The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress.
  measure: Timed up and go test
  time frame: 5minutes
  description: The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility.
  measure: The postural assessment scale for stroke patients
  time frame: 10 minutes
  description: Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.
  measure: Barthel index
  time frame: 5minutes
  description: The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence.
  measure: Electroencephalography
  time frame: 20minutes
  description: Electroencephalography is used obtain power data of total μ (8-12Hz), lower μ (8-10Hz), and upper μ (10-12Hz).
  μ suppression→ a negative value (<0) indicates inhibition of μ waves, indicating activation in the motor cortex(Bae et al., 2012).
  arm group label: Mirror therapy
  arm group type: Experimental
  arm group label: Mirror Therapy + Electrical Stimulation
  arm group type: Experimental
  arm group label: Mirror Therapy + Binaural Beat
  arm group type: Experimental
  intervention type: Other
  intervention name: Mirror Therapy
  description: Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises.
  Duration: 5 seconds, Rest: 5 seconds
  arm group label: Mirror therapy
  intervention type: Other
  intervention name: Mirror Therapy + Electrical Stimulation
  description: Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.
  arm group label: Mirror Therapy + Electrical Stimulation
  intervention type: Other
  intervention name: Mirror Therapy + Binaural Beat
  description: Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation
  arm group label: Mirror Therapy + Binaural Beat
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: LIN JAU HONG, Ph.D.
  role: Study Chair
  affiliation: Kaohsiung Medical University,department of Physical Therapy
  last name: LIN JAU HONG, Ph.D.
  phone: 0929393300
  email: jhlin@kmu.edu.tw
  last name: LIN YEN YU, Master's degree
  phone: 0988392631
  email: yenyu.lin88@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No
  ipd description: During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data