<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/NCT01662960</url>
  </required_header>
  <id_info>
    <org_study_id>HN 4404</org_study_id>
    <secondary_id>NIH R01 HD068565</secondary_id>
    <nct_id>NCT01662960</nct_id>
  </id_info>
  <brief_title>Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke</brief_title>
  <official_title>Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine whether an existing treatment for problems that&#xD;
      participants have with making movements after a stroke can be performed at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will compare two forms of home-based treatment for post-stroke problems making&#xD;
      movements with the arms and hands. After initial pre-treatment assessments, participants will&#xD;
      complete 4 weeks of treatment, with assessments after each week of treatment and 3 months&#xD;
      after the completion of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2012</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 2017</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Upper Extremity Fugl-Meyer</measure>
    <time_frame>Immediately after 1 month of treatment</time_frame>
    <description>This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>1 month</time_frame>
    <description>The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rivermead Assessment of Somatosensory Performance</measure>
    <time_frame>1 month</time_frame>
    <description>This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virtual-reality Assessment of Navigation</measure>
    <time_frame>1 month</time_frame>
    <description>This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>1 month</time_frame>
    <description>This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test</measure>
    <time_frame>1 months</time_frame>
    <description>The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Hemiparesis</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Mirror therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Divider therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mirror therapy</intervention_name>
    <description>A home-based therapy involving mirrored visual feedback</description>
    <arm_group_label>Mirror therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Divider therapy</intervention_name>
    <description>A home-based therapy involving removed visual feedback.</description>
    <arm_group_label>Divider therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 months or more post-stroke&#xD;
&#xD;
          -  upper extremity Fugl-Meyer score between 10 and 50&#xD;
&#xD;
          -  no longer participating in upper-extremity physical or occupational therapy&#xD;
&#xD;
          -  sufficient comprehension ability to understand instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous head trauma, psychiatric illness or chronic exposure to medications that&#xD;
             might be expected to have lasting consequences for the central nervous system (e.g.,&#xD;
             haloperidol, dopaminergics)&#xD;
&#xD;
          -  dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Jax, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein Healthcare Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Einstein Medical Center Elkins Park</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>February 12, 2019</results_first_submitted>
  <results_first_submitted_qc>February 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 13, 2019</results_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Steve Jax</investigator_full_name>
    <investigator_title>Institute Scientist</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>hemiparesis</keyword>
  <keyword>arm movement</keyword>
  <keyword>sensory functioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT01662960/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mirror Therapy: High Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="P2">
          <title>Mirror Therapy: Low Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
        <group group_id="P3">
          <title>Divider Therapy: High Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="P4">
          <title>Divider Therapy: Low Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>End of 4 Week Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mirror Therapy: High Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="B2">
          <title>Mirror Therapy: Low Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
        <group group_id="B3">
          <title>Divider Therapy: High Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="B4">
          <title>Divider Therapy: Low Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="12.3"/>
                    <measurement group_id="B2" value="53.7" spread="14.9"/>
                    <measurement group_id="B3" value="55.9" spread="9.7"/>
                    <measurement group_id="B4" value="57.5" spread="12.7"/>
                    <measurement group_id="B5" value="57.3" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Upper Extremity Fugl-Meyer</title>
          <description>This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.1" spread="6.1"/>
                    <measurement group_id="B2" value="17.5" spread="4.2"/>
                    <measurement group_id="B3" value="39.9" spread="7.8"/>
                    <measurement group_id="B4" value="18.8" spread="6.1"/>
                    <measurement group_id="B5" value="28.1" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Action Research Arm Test</title>
          <description>The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.1" spread="9.9"/>
                    <measurement group_id="B2" value="5.8" spread="4.4"/>
                    <measurement group_id="B3" value="36.3" spread="13.3"/>
                    <measurement group_id="B4" value="6.7" spread="4.4"/>
                    <measurement group_id="B5" value="20.3" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rivermead Assessment of Somatosensory Performance</title>
          <description>This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.</description>
          <units>Proportion of items correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.72" spread="0.17"/>
                    <measurement group_id="B2" value="0.53" spread="0.19"/>
                    <measurement group_id="B3" value="0.79" spread="0.20"/>
                    <measurement group_id="B4" value="0.56" spread="0.21"/>
                    <measurement group_id="B5" value="0.63" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke Impact Scale</title>
          <description>This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="215.9" spread="26.4"/>
                    <measurement group_id="B2" value="219.9" spread="35.0"/>
                    <measurement group_id="B3" value="226.3" spread="15.3"/>
                    <measurement group_id="B4" value="215.7" spread="28.7"/>
                    <measurement group_id="B5" value="218.4" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wolf Motor Function Test</title>
          <description>The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.8" spread="9.5"/>
                    <measurement group_id="B2" value="22.7" spread="5.7"/>
                    <measurement group_id="B3" value="50.8" spread="14.4"/>
                    <measurement group_id="B4" value="25.1" spread="7.2"/>
                    <measurement group_id="B5" value="35.8" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Virtual-reality Assessment of Navigation</title>
          <description>This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.</description>
          <units>proportion difference</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".047" spread=".051"/>
                    <measurement group_id="B2" value=".056" spread=".059"/>
                    <measurement group_id="B3" value=".022" spread=".036"/>
                    <measurement group_id="B4" value=".063" spread=".086"/>
                    <measurement group_id="B5" value=".050" spread=".062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Upper Extremity Fugl-Meyer</title>
        <description>This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.</description>
        <time_frame>Immediately after 1 month of treatment</time_frame>
        <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Upper Extremity Fugl-Meyer</title>
          <description>This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.</description>
          <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" spread="9.4"/>
                    <measurement group_id="O2" value="21.4" spread="5.7"/>
                    <measurement group_id="O3" value="42.8" spread="8.7"/>
                    <measurement group_id="O4" value="21.5" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Test for the superiority of Mirror therapy over Divider therapy.</non_inferiority_desc>
            <p_value>.443</p_value>
            <p_value_desc>ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>2.2</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Action Research Arm Test</title>
        <description>The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.</description>
        <time_frame>1 month</time_frame>
        <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Action Research Arm Test</title>
          <description>The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.</description>
          <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" spread="11.8"/>
                    <measurement group_id="O2" value="7.1" spread="5.0"/>
                    <measurement group_id="O3" value="39.1" spread="13.6"/>
                    <measurement group_id="O4" value="7.7" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Test for the superiority of Mirror therapy over Divider therapy.</non_inferiority_desc>
            <p_value>.80</p_value>
            <p_value_desc>ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>0.4</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rivermead Assessment of Somatosensory Performance</title>
        <description>This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.</description>
        <time_frame>1 month</time_frame>
        <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Rivermead Assessment of Somatosensory Performance</title>
          <description>This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.</description>
          <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
          <units>Proportion of items correct.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.18"/>
                    <measurement group_id="O2" value="0.52" spread="0.19"/>
                    <measurement group_id="O3" value="0.79" spread="0.18"/>
                    <measurement group_id="O4" value="0.60" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Test for the superiority of Mirror therapy over Divider therapy.</non_inferiority_desc>
            <p_value>.93</p_value>
            <p_value_desc>ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-.002</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Virtual-reality Assessment of Navigation</title>
        <description>This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.</description>
        <time_frame>1 month</time_frame>
        <population>No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Virtual-reality Assessment of Navigation</title>
          <description>This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.</description>
          <population>No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stroke Impact Scale</title>
        <description>This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.</description>
        <time_frame>1 month</time_frame>
        <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Impact Scale</title>
          <description>This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.</description>
          <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="221.0" spread="32.5"/>
                    <measurement group_id="O2" value="231.6" spread="43.7"/>
                    <measurement group_id="O3" value="237.8" spread="25.7"/>
                    <measurement group_id="O4" value="217.0" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Test for the superiority of Mirror therapy over Divider therapy.</non_inferiority_desc>
            <p_value>.28</p_value>
            <p_value_desc>ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>10.7</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wolf Motor Function Test</title>
        <description>The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.</description>
        <time_frame>1 months</time_frame>
        <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Therapy: High Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O2">
            <title>Mirror Therapy: Low Functioning</title>
            <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
          <group group_id="O3">
            <title>Divider Therapy: High Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
          </group>
          <group group_id="O4">
            <title>Divider Therapy: Low Functioning</title>
            <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
          </group>
        </group_list>
        <measure>
          <title>Wolf Motor Function Test</title>
          <description>The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.</description>
          <population>All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" spread="10.0"/>
                    <measurement group_id="O2" value="22.3" spread="6.0"/>
                    <measurement group_id="O3" value="50.4" spread="13.8"/>
                    <measurement group_id="O4" value="24.7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Test for the superiority of Mirror therapy over Divider therapy.</non_inferiority_desc>
            <p_value>.86</p_value>
            <p_value_desc>ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-.36</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline screening until 3-month post-treatment follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mirror Therapy: High Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="E2">
          <title>Mirror Therapy: Low Functioning</title>
          <description>4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
        <group group_id="E3">
          <title>Divider Therapy: High Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.</description>
        </group>
        <group group_id="E4">
          <title>Divider Therapy: Low Functioning</title>
          <description>4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.&#xD;
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Steven Jax</name_or_title>
      <organization>Albert Einstein Healthcare Network</organization>
      <phone>215-870-0196</phone>
      <email>stevenandrewjax@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662960
org study id: HN 4404
secondary id: NIH R01 HD068565
nct id: NCT01662960
lead sponsor: 
has dmc: No
The purpose of the study is to determine whether an existing treatment for problems that
      participants have with making movements after a stroke can be performed at home.
This study will compare two forms of home-based treatment for post-stroke problems making
      movements with the arms and hands. After initial pre-treatment assessments, participants will
      complete 4 weeks of treatment, with assessments after each week of treatment and 3 months
      after the completion of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Upper Extremity Fugl-Meyer
time frame: Immediately after 1 month of treatment
description: This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
measure: Action Research Arm Test
time frame: 1 month
description: The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.
measure: Rivermead Assessment of Somatosensory Performance
time frame: 1 month
description: This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.
measure: Virtual-reality Assessment of Navigation
time frame: 1 month
description: This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.
measure: Stroke Impact Scale
time frame: 1 month
description: This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.
measure: Wolf Motor Function Test
time frame: 1 months
description: The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.
arm group label: Mirror therapy
arm group type: Experimental
description: 4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
arm group label: Divider therapy
arm group type: Active Comparator
description: 4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
intervention type: Behavioral
intervention name: Mirror therapy
description: A home-based therapy involving mirrored visual feedback
arm group label: Mirror therapy
intervention type: Behavioral
intervention name: Divider therapy
description: A home-based therapy involving removed visual feedback.
arm group label: Divider therapy
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Steven Jax, Ph. D.
role: Principal Investigator
affiliation: Albert Einstein Healthcare Network
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Steve Jax
investigator title: Institute Scientist
mesh term: Stroke
mesh term: Paresis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 