<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/NCT03246139</url>
  </required_header>
  <id_info>
    <org_study_id>201602056A3</org_study_id>
    <secondary_id>N201705016</secondary_id>
    <nct_id>NCT03246139</nct_id>
  </id_info>
  <brief_title>Action Observation, Imagery and Execution for Stroke Rehabilitation</brief_title>
  <official_title>Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung 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>
      The specific study aims will be:&#xD;
&#xD;
        1. To investigate the short- and long-term treatment effects of action observation,&#xD;
           imagery, and execution therapy (AOIE) compared with an action observation therapy (AO)&#xD;
           group and a control treatment group as controls on different aspects of outcomes in&#xD;
           patients with stroke.&#xD;
&#xD;
        2. To examine the neural mechanisms and changes in cortical neural activity after the&#xD;
           interventions in stroke patients.&#xD;
&#xD;
        3. To examine the correlations between AOIE-induced brain activation changes and the&#xD;
           clinical efficacy of AOIE.&#xD;
&#xD;
        4. To identify who are the possible good responders to the therapy based on baseline motor&#xD;
           function and motor imagery ability of the participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a 3-year randomized controlled trial to (1) investigate the short-&#xD;
      and long-term treatment efficacy of AOIE, action observation alone, versus control treatment&#xD;
      on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and&#xD;
      activation changes after the 3 interventions by using an advanced brain imaging technique,&#xD;
      magnetoencephalography (MEG), (3) determine the correlations between neural activation&#xD;
      changes and clinical outcomes, and (4) identify who are the good responders to the AOIE&#xD;
      therapy. An estimated total of 96 patients with subacute stroke will be recruited in this&#xD;
      study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3&#xD;
      weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline,&#xD;
      immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be&#xD;
      conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The&#xD;
      investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging&#xD;
      evaluation because of the specific eligibility criteria and high costs of MEG. The patients&#xD;
      can still participate in the study, receiving rehabilitation therapy and clinical&#xD;
      evaluations, even if the participants will not be included in the MEG study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>Change scores of Modified Rankin Scale</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The Modified Rankin Scale is used to assess the degree of stroke disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Fugl-Meyer Assessment</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores of Box and Block Test</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The CAHAI measures the upper-limb motor function after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Movement Imagery Questionnaire, revised second version</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The MIQ-RS will be applied to assess patient's ability of motor imagery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Functional Independence Measure</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of physical intensity measured by activity monitors</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of energy expenditure measured by activity monitors</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Stroke Impact Scale (SIS) Version 3.0</measure>
    <time_frame>baseline, 3 weeks , 3 months</time_frame>
    <description>The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetoencephalography (MEG)</measure>
    <time_frame>baseline, 3 weeks</time_frame>
    <description>Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Action observation, imagery &amp; execution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Action observation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action observation, imagery &amp; execution</intervention_name>
    <description>The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.</description>
    <arm_group_label>Action observation, imagery &amp; execution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action observation</intervention_name>
    <description>The participants will be asked to observe videos and then practice what the participants observed.</description>
    <arm_group_label>Action observation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control treatment</intervention_name>
    <description>The participants will receive UE training without watching videos or imagining movements/tasks.</description>
    <arm_group_label>Control treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as having a unilateral stroke;&#xD;
&#xD;
          -  1 to 12 months after stroke onset&#xD;
&#xD;
          -  from 20 to 80 years of age&#xD;
&#xD;
          -  a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60&#xD;
&#xD;
          -  able to follow the study instructions&#xD;
&#xD;
          -  capable of participating in therapy and assessment sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with global or receptive aphasia,&#xD;
&#xD;
          -  severe neglect&#xD;
&#xD;
          -  major medical problems, or comorbidities that influenced UE usage or caused severe&#xD;
             pain&#xD;
&#xD;
        Additionally, if patients have no metal implants, no head traumas or neurosurgical&#xD;
        operations, and can perform MEG motor tasks, the participants can additionally participate&#xD;
        in the MEG assessment.&#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_official>
    <last_name>Yu-Wei Hsieh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei medical university hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Shuang Ho Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taoyuan Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare</name>
      <address>
        <city>Taoyuan City</city>
        <zip>3351</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>neurorehabilitation</keyword>
  <keyword>mirror neuron system</keyword>
  <keyword>action observation</keyword>
  <keyword>motor imagery</keyword>
  <keyword>MEG</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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246139
org study id: 201602056A3
secondary id: N201705016
nct id: NCT03246139
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The specific study aims will be:

        1. To investigate the short- and long-term treatment effects of action observation,
           imagery, and execution therapy (AOIE) compared with an action observation therapy (AO)
           group and a control treatment group as controls on different aspects of outcomes in
           patients with stroke.

        2. To examine the neural mechanisms and changes in cortical neural activity after the
           interventions in stroke patients.

        3. To examine the correlations between AOIE-induced brain activation changes and the
           clinical efficacy of AOIE.

        4. To identify who are the possible good responders to the therapy based on baseline motor
           function and motor imagery ability of the participants.
The investigators propose a 3-year randomized controlled trial to (1) investigate the short-
      and long-term treatment efficacy of AOIE, action observation alone, versus control treatment
      on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and
      activation changes after the 3 interventions by using an advanced brain imaging technique,
      magnetoencephalography (MEG), (3) determine the correlations between neural activation
      changes and clinical outcomes, and (4) identify who are the good responders to the AOIE
      therapy. An estimated total of 96 patients with subacute stroke will be recruited in this
      study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3
      weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline,
      immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be
      conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The
      investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging
      evaluation because of the specific eligibility criteria and high costs of MEG. The patients
      can still participate in the study, receiving rehabilitation therapy and clinical
      evaluations, even if the participants will not be included in the MEG study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change scores of Modified Rankin Scale
time frame: baseline, 3 weeks , 3 months
description: The Modified Rankin Scale is used to assess the degree of stroke disability.
measure: Change scores of Fugl-Meyer Assessment
time frame: baseline, 3 weeks , 3 months
description: Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
measure: Change scores of Box and Block Test
time frame: baseline, 3 weeks , 3 months
description: The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
measure: Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
time frame: baseline, 3 weeks , 3 months
description: The CAHAI measures the upper-limb motor function after stroke.
measure: Change scores of Movement Imagery Questionnaire, revised second version
time frame: baseline, 3 weeks , 3 months
description: The MIQ-RS will be applied to assess patient's ability of motor imagery.
measure: Change scores of Functional Independence Measure
time frame: baseline, 3 weeks , 3 months
description: The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
measure: Change scores of physical intensity measured by activity monitors
time frame: baseline, 3 weeks , 3 months
description: The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.
measure: Change scores of energy expenditure measured by activity monitors
time frame: baseline, 3 weeks , 3 months
description: The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.
measure: Change scores of Stroke Impact Scale (SIS) Version 3.0
time frame: baseline, 3 weeks , 3 months
description: The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.
measure: Magnetoencephalography (MEG)
time frame: baseline, 3 weeks
description: Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).
arm group label: Action observation, imagery & execution
arm group type: Experimental
arm group label: Action observation
arm group type: Active Comparator
arm group label: Control treatment
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Action observation, imagery & execution
description: The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
arm group label: Action observation, imagery & execution
intervention type: Behavioral
intervention name: Action observation
description: The participants will be asked to observe videos and then practice what the participants observed.
arm group label: Action observation
intervention type: Behavioral
intervention name: Control treatment
description: The participants will receive UE training without watching videos or imagining movements/tasks.
arm group label: Control treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu-Wei Hsieh, PhD
role: Principal Investigator
affiliation: Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No