<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/NCT02249832</url>
  </required_header>
  <id_info>
    <org_study_id>13-310</org_study_id>
    <nct_id>NCT02249832</nct_id>
  </id_info>
  <brief_title>The General Use of Robots in Stroke Recovery: the Anklebot</brief_title>
  <official_title>The General Use of Robots in Stroke Recovery: the Anklebot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if isolated robot-assisted training of the ankle&#xD;
      joint improves chronic hemiparetic gait in patients after stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by average admission gait speed on the 10 Meter Walk Test at comfortable pace, according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) gait functioning.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.</measure>
    <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
    <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.</measure>
    <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
    <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.</measure>
    <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
    <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>seated robot-assisted ankle therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>seated robot-assisted ankle therapy</intervention_name>
    <description>The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.</description>
    <arm_group_label>seated robot-assisted ankle therapy</arm_group_label>
    <other_name>Massachusetts Insititute of Technology (MIT) Anklebot</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  First single focal unilateral lesion with diagnosis verified by brain imaging, which&#xD;
             occurred at least 6 months prior&#xD;
&#xD;
          -  Cognitive function sufficient enough to understand experiments and follow instructions&#xD;
&#xD;
          -  Some amount of independent ambulation (with orthoses or walker)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Botox treatment within 6-weeks of enrollment;&#xD;
&#xD;
          -  Fixed contraction deformity in the affected limb;&#xD;
&#xD;
          -  Complete and total flaccid paralysis of all lower extremity motor function;&#xD;
&#xD;
          -  Unable to ambulate except with the aid of another person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Feinstein Institutes for Medical Research</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Transitions of Long Island Outpatient Rehabilitation</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Khanna I, Roy A, Rodgers MM, Krebs HI, Macko RM, Forrester LW. Effects of unilateral robotic limb loading on gait characteristics in subjects with chronic stroke. J Neuroeng Rehabil. 2010 May 21;7:23. doi: 10.1186/1743-0003-7-23.</citation>
    <PMID>20492698</PMID>
  </reference>
  <reference>
    <citation>Roy A, Krebs HI, Bever CT, Forrester LW, Macko RF, Hogan N. Measurement of passive ankle stiffness in subjects with chronic hemiparesis using a novel ankle robot. J Neurophysiol. 2011 May;105(5):2132-49. doi: 10.1152/jn.01014.2010. Epub 2011 Feb 23.</citation>
    <PMID>21346215</PMID>
  </reference>
  <reference>
    <citation>Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.</citation>
    <PMID>21115945</PMID>
  </reference>
  <reference>
    <citation>Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.</citation>
    <PMID>24515923</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>September 25, 2019</results_first_submitted>
  <results_first_submitted_qc>November 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2019</results_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Bruce Volpe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>CVA</keyword>
  <keyword>cerebrovascular accident</keyword>
  <keyword>cerebral stroke</keyword>
  <keyword>robotic therapy</keyword>
  <keyword>anklebot</keyword>
  <keyword>physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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>May 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT02249832/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT02249832/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All participants received eighteen sessions of seated anklebot training. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Seated Robotic Ankle Therapy</title>
          <description>Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Seated Robotic Ankle Therapy</title>
          <description>Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.</title>
        <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
        <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
        <population>Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Gait Speed Group</title>
            <description>The low gait speed group included all subjects with a mean gait speed of &lt;0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Gait Speed Group</title>
            <description>The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
          <group group_id="O3">
            <title>High Gait Speed Group</title>
            <description>The high gait speed group included all subjects with a mean gait speed of &gt;0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.</title>
          <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
          <population>Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.</population>
          <units>m/sec</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean gait speed at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.02"/>
                    <measurement group_id="O2" value="0.53" spread="0.03"/>
                    <measurement group_id="O3" value="1.02" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean gait speed at discharge (week 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.02"/>
                    <measurement group_id="O2" value="0.62" spread="0.04"/>
                    <measurement group_id="O3" value="1.18" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean gait speed at 3month FU (overall week 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.02"/>
                    <measurement group_id="O2" value="0.66" spread="0.04"/>
                    <measurement group_id="O3" value="1.29" spread="0.10"/>
                  </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_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A significance level of 0.05 was used (two-sided).</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.</title>
        <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
        <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
        <population>Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Gait Speed Group</title>
            <description>The low gait speed group included all subjects with a mean gait speed of &lt;0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Gait Speed Group</title>
            <description>The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.</description>
          </group>
          <group group_id="O3">
            <title>High Gait Speed Group</title>
            <description>The high gait speed group included all subjects with a mean gait speed of &gt;0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.</title>
          <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
          <population>Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.</population>
          <units>m/sec</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mean gait speed at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.02"/>
                    <measurement group_id="O2" value="0.67" spread="0.06"/>
                    <measurement group_id="O3" value="1.30" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean gait speed at discharge (week 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.03"/>
                    <measurement group_id="O2" value="0.79" spread="0.06"/>
                    <measurement group_id="O3" value="1.41" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean gait speed at 3 month FU (overall week 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="0.03"/>
                    <measurement group_id="O2" value="0.84" spread="0.10"/>
                    <measurement group_id="O3" value="1.79" spread="0.26"/>
                  </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_list>
            <groups_desc>A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A significance level of 0.05 was used (two-sided).</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.</title>
        <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
        <time_frame>baseline, discharge (week 6), 3 month FU (overall week 18)</time_frame>
        <population>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance levels.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Gait Speed Group</title>
            <description>The low gait speed group included all subjects with a mean gait speed of &lt;0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Gait Speed Group</title>
            <description>The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
          <group group_id="O3">
            <title>High Gait Speed Group</title>
            <description>The high gait speed group included all subjects with a mean gait speed of &gt;0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.</title>
          <description>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).</description>
          <population>Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance levels.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mean distance at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.46" spread="5.76"/>
                    <measurement group_id="O2" value="152.92" spread="9.53"/>
                    <measurement group_id="O3" value="280.43" spread="19.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean distance at discharge (week 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.33" spread="5.38"/>
                    <measurement group_id="O2" value="180.11" spread="11.64"/>
                    <measurement group_id="O3" value="319.79" spread="22.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean distance at 3 month FU (overall week18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.07" spread="5.62"/>
                    <measurement group_id="O2" value="183.34" spread="14.33"/>
                    <measurement group_id="O3" value="314.43" spread="21.46"/>
                  </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_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).</non_inferiority_desc>
            <p_value>0.001</p_value>
            <p_value_desc>A significance level of 0.05 was used (two-sided).</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).</time_frame>
      <desc>Safety population included all participants who enrolled in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Seated Robotic Ankle Therapy</title>
          <description>All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (&lt;0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (&gt;0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>worsening baseline ankle pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>neuropathic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </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>Bruce T. Volpe, MD</name_or_title>
      <organization>Feinstein Institutes for Medical Research</organization>
      <phone>(516) 562-3384</phone>
      <email>bvolpe1@northwell.edu</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/NCT02249832
org study id: 13-310
nct id: NCT02249832
lead sponsor: 
has dmc: No
The purpose of this study is to determine if isolated robot-assisted training of the ankle
      joint improves chronic hemiparetic gait in patients after stroke.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by average admission gait speed on the 10 Meter Walk Test at comfortable pace, according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) gait functioning.
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
time frame: baseline, discharge (week 6), 3 month FU (overall week 18)
description: Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
measure: Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.
time frame: baseline, discharge (week 6), 3 month FU (overall week 18)
description: Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
measure: Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.
time frame: baseline, discharge (week 6), 3 month FU (overall week 18)
description: Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
arm group label: seated robot-assisted ankle therapy
arm group type: Experimental
description: All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning.
intervention type: Device
intervention name: seated robot-assisted ankle therapy
description: The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.
arm group label: seated robot-assisted ankle therapy
other name: Massachusetts Insititute of Technology (MIT) Anklebot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
citation: Khanna I, Roy A, Rodgers MM, Krebs HI, Macko RM, Forrester LW. Effects of unilateral robotic limb loading on gait characteristics in subjects with chronic stroke. J Neuroeng Rehabil. 2010 May 21;7:23. doi: 10.1186/1743-0003-7-23.
PMID: 20492698
citation: Roy A, Krebs HI, Bever CT, Forrester LW, Macko RF, Hogan N. Measurement of passive ankle stiffness in subjects with chronic hemiparesis using a novel ankle robot. J Neurophysiol. 2011 May;105(5):2132-49. doi: 10.1152/jn.01014.2010. Epub 2011 Feb 23.
PMID: 21346215
citation: Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.
PMID: 21115945
citation: Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.
PMID: 24515923
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Bruce Volpe
investigator title: Principal Investigator
mesh term: Stroke
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 