<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/NCT03828214</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03828214</nct_id>
  </id_info>
  <brief_title>Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton</brief_title>
  <official_title>Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>College of St. Scholastica, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Honda R and D Americas, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>College of St. Scholastica, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground&#xD;
      reaction forces and spatiotemporal characteristics during walking in persons post stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall&#xD;
      short of achieving desirable walking outcomes for most people who experience stroke. Robotic&#xD;
      methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R &amp;&#xD;
      D Americas Inc., are being explored as a means of improving the recovery of walking post&#xD;
      stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is&#xD;
      important to understand their effect on kinematic and muscle responses during walking.&#xD;
      Kinematic and muscle responses at the hip during walking with the HWA were recently&#xD;
      described.&#xD;
&#xD;
      The purpose of this study is to quantify the effect of walking with the HWA on body segments&#xD;
      remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive&#xD;
      measures used will include: walking kinematics (measurement of joint angles using cameras),&#xD;
      muscle activity (Electromyography), ground reaction forces (detected by a force plate in the&#xD;
      floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected&#xD;
      under three conditions: 1) walking at self-selected pace (control), 2) walking at&#xD;
      self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension),&#xD;
      3) walking immediately following HWA use (aftereffect).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 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>Within-subject design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait Kinematics</measure>
    <time_frame>Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.</time_frame>
    <description>Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lower Limb Electromyography (EMG)</measure>
    <time_frame>Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.</time_frame>
    <description>Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ground Reaction Force at Terminal Stance</measure>
    <time_frame>Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.</time_frame>
    <description>2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stair Climbing Ascend/Descend Test</measure>
    <time_frame>Stairs will be measured at a single time point (in one 2-hour session) for each participant</time_frame>
    <description>A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic exoskeleton for walking assist</intervention_name>
    <description>Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&amp;D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥12 weeks but &lt;1 year post stroke at time of study participation&#xD;
&#xD;
          -  Age: 18-85 years&#xD;
&#xD;
          -  Ability to walk a minimum of 10 meters with standby assistance with or without&#xD;
             orthosis or assistive device (Functional Ambulation categories 3, 4 or 5)&#xD;
&#xD;
          -  Able to follow three step commands&#xD;
&#xD;
          -  Express the ability to understand study tasks and purpose&#xD;
&#xD;
          -  Able and willing to provide written informed consent&#xD;
&#xD;
          -  Living in the community with the ability to travel to maurices Community Clinic for&#xD;
             testing&#xD;
&#xD;
          -  Willingness to wear the StepWatch pedometer for a period of 3 days in their home&#xD;
&#xD;
          -  (If applicable) ≥ 90 days post major orthopedic surgery (such as a joint replacement)&#xD;
&#xD;
          -  (If applicable) ≥ 6 months post cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious cardiac conditions (hospitalized for myocardial infarction or heart surgery&#xD;
             within 3 months, congestive heart failure, unstable cardiac arrhythmias, hypertrophic&#xD;
             cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities&#xD;
             of daily living)&#xD;
&#xD;
          -  Severe arthritis or orthopedic conditions that limit lower extremity range of motion&#xD;
             (&gt; 10° or &lt; 90° knee flexion, lacking &gt; 25° hip extension, &gt;15° from neutral plantar&#xD;
             flexion.)&#xD;
&#xD;
          -  Preexisting neurologic disorders such as Dementia, Multiple Sclerosis, Amyotrophic&#xD;
             Lateral Sclerosis, Parkinson's Disease or Ataxia.&#xD;
&#xD;
          -  History of lower limb amputation, non-healing ulcers, legal blindness or severe visual&#xD;
             impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra L Borstad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of St. Scholastica</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of St. Scholastica-Health Science Center</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>August 4, 2021</results_first_submitted>
  <results_first_submitted_qc>February 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2023</results_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>College of St. Scholastica, Inc.</investigator_affiliation>
    <investigator_full_name>Alexandra Borstad</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>exoskeleton</keyword>
  <keyword>gait</keyword>
  <keyword>kinematics</keyword>
  <keyword>EMG</keyword>
  <keyword>stair climbing</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>October 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03828214/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Walking</title>
          <description>In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11">11 participants completed this study, however, for some outcome variables, only data from 9 or 10 participants was available for analysis due to technical challenges during data collection.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Walking</title>
          <description>In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="12.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke affected side was left</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time post stroke</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fugl-meyer Assessment</title>
          <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.&#xD;
For this study the FM Lower extremity subset was used to characterize participants. Scores on this subset could range from 0-34 points. Higher scores indicate less lower extremity impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Montreal Cognitive Assessment (MoCA)</title>
          <description>The Montreal Cognitive Assessment (MoCA) is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment and Alzheimer's disease. The total possible score is 30 points. Greater than or equal to 26 is considered normal cognitive function for an adult.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.4" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Activities Specific Balance Confidence Scale</title>
          <description>The ABC Scale is a 16 item self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. For each item participants rate them selves from 0 (no confidence) to 100 (complete confidence). The total score is an average across the 16 items.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.9" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Steps per day</title>
          <description>Average steps from a 3 day sample quantified using StepWatch.</description>
          <units>steps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2783" spread="1512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Gait Kinematics</title>
        <description>Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally.</description>
        <time_frame>Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.</time_frame>
        <population>For one participant data was not available for the C3 condition</population>
        <group_list>
          <group group_id="O1">
            <title>Walking</title>
            <description>In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
          </group>
        </group_list>
        <measure>
          <title>Gait Kinematics</title>
          <description>Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally.</description>
          <population>For one participant data was not available for the C3 condition</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.8" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.3" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>C2, C3, C4 were compared to C1 the comparison condition.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.973</p_value>
            <p_value_desc>a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.4</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>9.2</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lower Limb Electromyography (EMG)</title>
        <description>Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.</description>
        <time_frame>Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.</time_frame>
        <population>There was a single group that participated in this within subject design study, here we compare the outcome parameter across the four conditions for this group.</population>
        <group_list>
          <group group_id="O1">
            <title>Walking</title>
            <description>In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
          </group>
        </group_list>
        <measure>
          <title>Lower Limb Electromyography (EMG)</title>
          <description>Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.</description>
          <population>There was a single group that participated in this within subject design study, here we compare the outcome parameter across the four conditions for this group.</population>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.115" spread="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.115" spread="0.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.101" spread="0.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.119" spread="0.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ground Reaction Force at Terminal Stance</title>
        <description>2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.</description>
        <time_frame>Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.</time_frame>
        <population>n=9 for grf data 1 participant No HWA condition secondary to device slipping, 1 participant no clean force plate hits due to short step length.</population>
        <group_list>
          <group group_id="O1">
            <title>Walking</title>
            <description>In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
          </group>
        </group_list>
        <measure>
          <title>Ground Reaction Force at Terminal Stance</title>
          <description>2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.</description>
          <population>n=9 for grf data 1 participant No HWA condition secondary to device slipping, 1 participant no clean force plate hits due to short step length.</population>
          <units>percentage of body weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stair Climbing Ascend/Descend Test</title>
        <description>A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)</description>
        <time_frame>Stairs will be measured at a single time point (in one 2-hour session) for each participant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking</title>
            <description>In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</description>
          </group>
        </group_list>
        <measure>
          <title>Stair Climbing Ascend/Descend Test</title>
          <description>A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ascend (control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.03" lower_limit="4.2" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>decend (control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.61" lower_limit="4" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ascend with HWA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.10" lower_limit="4" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>descend with HWA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.99" lower_limit="4.1" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected during the one day period of participation in the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Walking</title>
          <description>In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)</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="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </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="11"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Alexandra Borstad</name_or_title>
      <organization>College of St. Scholastica</organization>
      <phone>614-395-1708</phone>
      <email>aborstad@css.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/NCT03828214
org study id: 001
nct id: NCT03828214
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground
      reaction forces and spatiotemporal characteristics during walking in persons post stroke.
Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall
      short of achieving desirable walking outcomes for most people who experience stroke. Robotic
      methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R &
      D Americas Inc., are being explored as a means of improving the recovery of walking post
      stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is
      important to understand their effect on kinematic and muscle responses during walking.
      Kinematic and muscle responses at the hip during walking with the HWA were recently
      described.

      The purpose of this study is to quantify the effect of walking with the HWA on body segments
      remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive
      measures used will include: walking kinematics (measurement of joint angles using cameras),
      muscle activity (Electromyography), ground reaction forces (detected by a force plate in the
      floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected
      under three conditions: 1) walking at self-selected pace (control), 2) walking at
      self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension),
      3) walking immediately following HWA use (aftereffect).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Within-subject design
primary purpose: Basic Science
masking: None (Open Label)
measure: Gait Kinematics
time frame: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.
description: Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally.
measure: Lower Limb Electromyography (EMG)
time frame: Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.
description: Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.
measure: Ground Reaction Force at Terminal Stance
time frame: Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.
description: 2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.
measure: Stair Climbing Ascend/Descend Test
time frame: Stairs will be measured at a single time point (in one 2-hour session) for each participant
description: A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)
intervention type: Device
intervention name: Robotic exoskeleton for walking assist
description: Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Alexandra L Borstad, PhD
role: Principal Investigator
affiliation: College of St. Scholastica
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: College of St. Scholastica, Inc.
investigator full name: Alexandra Borstad
investigator title: Associate Professor
mesh term: Stroke
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 