<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/NCT03751371</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0397</org_study_id>
    <nct_id>NCT03751371</nct_id>
  </id_info>
  <brief_title>Robotic Walking Device to Improve Mobility in Parkinson's Disease</brief_title>
  <official_title>Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Honda Research and Development Americas, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase II randomized controlled trial proposes to examine the impact of long-term use of&#xD;
      a novel light-weight and wearable assistive robotic device, called the Honda Walking Assist&#xD;
      (HWA) device, to improve mobility in the home and community in individuals with mild to&#xD;
      moderate Parkinson's disease (PD). Specific aims of the project are to: 1) determine the&#xD;
      short-term impact of mechanical gait assistance on efficiency and ease of walking in&#xD;
      individuals with PD, and 2) determine the effect of long-term HWA device usage on the ease&#xD;
      and ability to walk unassisted in the home and community in individuals with PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Difficulties with walking in people with Parkinson's disease contribute to injurious falls&#xD;
      and decreased quality of life. The Honda Walking Assist (HWA) robotic device is designed to&#xD;
      assist individuals with gait impairments to take longer strides and walk faster. This study&#xD;
      will investigate the impact of HWA usage on mobility in the home and community in individuals&#xD;
      with PD. It will also examine feasibility and safety of HWA usage in the PD population.&#xD;
      Specific Aim 1: Determine the short-term impact of mechanical gait assistance on efficiency&#xD;
      and ease of walking in individuals with PD. With disease progression, individuals with PD&#xD;
      develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased&#xD;
      step-to-step variability, and freezing of gait), that interfere with their abilities to&#xD;
      perform daily living tasks and participate in work, home, and social activities and&#xD;
      predispose them to falls. The investigators hypothesize that wearing the HWA device will&#xD;
      improve gait efficiency, gait parameters, and perceived ease of walking in individuals with&#xD;
      PD compared to unassisted walking over a one session period. Specific Aim 2: Determine the&#xD;
      effect of long-term HWA device usage on the ease and ability to walk unassisted in the home&#xD;
      and community in individuals with PD. Angular sensors embedded in the HWA monitor the&#xD;
      cadence, angular velocity, and degree of hip extension and flexion of the device user. When&#xD;
      the user initiates walking, the HWA automatically adjusts leg movements to reach target walk&#xD;
      ratios (step length/cadence) by increasing the amount of hip flexion and/or extension using&#xD;
      power supplied by the device. Thus, the HWA applies continuous, step-by-step cueing to&#xD;
      individuals with PD to take bigger and more symmetrical steps, thereby producing a faster and&#xD;
      more efficient walking pattern. By wearing the HWA device over an extended period of time,&#xD;
      individuals with PD will repetitively practice walking with a more &quot;normal&quot; gait pattern,&#xD;
      possibly driving neuroplastic changes that will translate to improve unassisted walking. The&#xD;
      investigators hypothesize that an 8-week intervention of HWA device usage will improve gait&#xD;
      efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical&#xD;
      activity in the home and community in individuals with PD with and without the use of the&#xD;
      device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">September 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait Velocity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Walking speed in meters per second</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walk Test</measure>
    <time_frame>8 weeks</time_frame>
    <description>Distance walked in 6 minutes, reported in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stride Length</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stride length in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Support Time</measure>
    <time_frame>8 weeks</time_frame>
    <description>Double support time in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swing Time - Right Leg</measure>
    <time_frame>8 weeks</time_frame>
    <description>Swing time in seconds of right leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swing Time - Left Leg</measure>
    <time_frame>8 weeks</time_frame>
    <description>Swing time in seconds of left leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Support Time Coefficient of Variation</measure>
    <time_frame>8 weeks</time_frame>
    <description>The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swing Time Coefficient of Variation of Right Leg</measure>
    <time_frame>8 weeks</time_frame>
    <description>The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swing Time Coefficient of Variation of Left Leg</measure>
    <time_frame>8 weeks</time_frame>
    <description>The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stride Length Coefficient of Variation</measure>
    <time_frame>8 weeks</time_frame>
    <description>The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Perceived Ease of Walking</measure>
    <time_frame>8 weeks</time_frame>
    <description>Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors &quot;Not at all easy&quot; at 0 on the left end, moderately easy at 5, and &quot;Extremely easy&quot; at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy for Measuring Chronic Disease 6-Item Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freezing of Gait Questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Falls</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of participants who recorded falls in a log during the 8-week intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Walking Training with the HWA Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training with HWA device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Training with HWA device</intervention_name>
    <description>Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
    <arm_group_label>Walking Training with the HWA Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic Parkinson's disease&#xD;
&#xD;
          -  Age 50-80 years&#xD;
&#xD;
          -  Able to ambulate without assistance (Hoehn &amp; Yahr stages 1-3)&#xD;
&#xD;
          -  On stable doses of Parkinson's medications for at least 4 weeks prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other significant cardiac, neurological or orthopedic problems that affect&#xD;
             gait&#xD;
&#xD;
          -  Weight more than 220 pounds and height greater than 6'8&quot;&#xD;
&#xD;
          -  Electronic medical devices embedded in the body&#xD;
&#xD;
          -  Participating in any physical therapy&#xD;
&#xD;
          -  Inability to understand instructions required by the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Kloos</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deb Kegelmeyer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>March 4, 2023</results_first_submitted>
  <results_first_submitted_qc>May 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2023</results_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Anne Kloos</investigator_full_name>
    <investigator_title>Professor-Clinical</investigator_title>
  </responsible_party>
  <keyword>Parkinson</keyword>
  <keyword>Exoskeleton</keyword>
  <keyword>Honda</keyword>
  <keyword>Walking Assist</keyword>
  <keyword>Walking</keyword>
  <keyword>Gait</keyword>
  <keyword>Mobility</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03751371/Prot_SAP_ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Walking Training With the HWA Device</title>
          <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Walking Training With the HWA Device</title>
          <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="45"/>
          </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="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" lower_limit="65.21" upper_limit="78.56"/>
                    <measurement group_id="B2" value="72" lower_limit="65.51" upper_limit="77.03"/>
                    <measurement group_id="B3" value="72" lower_limit="66" upper_limit="78"/>
                  </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="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Gait Velocity</title>
        <description>Walking speed in meters per second</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing gait velocity data for one participant in the Training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Gait Velocity</title>
          <description>Walking speed in meters per second</description>
          <population>Missing gait velocity data for one participant in the Training group</population>
          <units>Meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="0.30"/>
                    <measurement group_id="O2" value="1.25" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6-Minute Walk Test</title>
        <description>Distance walked in 6 minutes, reported in meters</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>6-Minute Walk Test</title>
          <description>Distance walked in 6 minutes, reported in meters</description>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.93" spread="124.35"/>
                    <measurement group_id="O2" value="426.92" spread="125.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stride Length</title>
        <description>Stride length in centimeters</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Stride Length</title>
          <description>Stride length in centimeters</description>
          <population>Missing data for one person in the training group</population>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.96" spread="25.53"/>
                    <measurement group_id="O2" value="131.79" spread="30.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Support Time</title>
        <description>Double support time in seconds</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Support Time</title>
          <description>Double support time in seconds</description>
          <population>Missing data for one person in the training group</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.01" spread="5.56"/>
                    <measurement group_id="O2" value="16.77" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swing Time - Right Leg</title>
        <description>Swing time in seconds of right leg</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Swing Time - Right Leg</title>
          <description>Swing time in seconds of right leg</description>
          <population>Missing data for one person in the training group</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.28" spread="2.93"/>
                    <measurement group_id="O2" value="41.94" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swing Time - Left Leg</title>
        <description>Swing time in seconds of left leg</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Swing Time - Left Leg</title>
          <description>Swing time in seconds of left leg</description>
          <population>Missing data for one person in the training group</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.86" spread="3.06"/>
                    <measurement group_id="O2" value="41.47" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Support Time Coefficient of Variation</title>
        <description>The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Support Time Coefficient of Variation</title>
          <description>The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
          <population>Missing data for one person in the training group</population>
          <units>Coefficient of variation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.09"/>
                    <measurement group_id="O2" value="0.23" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swing Time Coefficient of Variation of Right Leg</title>
        <description>The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Swing Time Coefficient of Variation of Right Leg</title>
          <description>The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
          <population>Missing data for one person in the training group</population>
          <units>Coefficient of variation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.02"/>
                    <measurement group_id="O2" value="0.05" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swing Time Coefficient of Variation of Left Leg</title>
        <description>The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Swing Time Coefficient of Variation of Left Leg</title>
          <description>The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
          <population>Missing data for one person in the training group</population>
          <units>Coefficient of variation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.02"/>
                    <measurement group_id="O2" value="0.06" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stride Length Coefficient of Variation</title>
        <description>The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
        <time_frame>8 weeks</time_frame>
        <population>Missing data for one person in the training group</population>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Stride Length Coefficient of Variation</title>
          <description>The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.</description>
          <population>Missing data for one person in the training group</population>
          <units>Coefficient of variation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.04"/>
                    <measurement group_id="O2" value="0.08" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Perceived Ease of Walking</title>
        <description>Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors &quot;Not at all easy&quot; at 0 on the left end, moderately easy at 5, and &quot;Extremely easy&quot; at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Perceived Ease of Walking</title>
          <description>Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors &quot;Not at all easy&quot; at 0 on the left end, moderately easy at 5, and &quot;Extremely easy&quot; at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.05" spread="1.96"/>
                    <measurement group_id="O2" value="7.47" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Efficacy for Measuring Chronic Disease 6-Item Scale</title>
        <description>Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy for Measuring Chronic Disease 6-Item Scale</title>
          <description>Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.71" spread="1.50"/>
                    <measurement group_id="O2" value="8.00" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Freezing of Gait Questionnaire</title>
        <description>The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Freezing of Gait Questionnaire</title>
          <description>The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.00" spread="6.49"/>
                    <measurement group_id="O2" value="9.85" spread="5.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Falls</title>
        <description>Number of participants who recorded falls in a log during the 8-week intervention</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Walking Training With the HWA Device</title>
            <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Falls</title>
          <description>Number of participants who recorded falls in a log during the 8-week intervention</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Walking Training With the HWA Device</title>
          <description>Training with HWA device&#xD;
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual Care&#xD;
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Anne Kloos</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-688-5942</phone>
      <email>kloos.4@osu.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/NCT03751371
org study id: 2018H0397
nct id: NCT03751371
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
This Phase II randomized controlled trial proposes to examine the impact of long-term use of
      a novel light-weight and wearable assistive robotic device, called the Honda Walking Assist
      (HWA) device, to improve mobility in the home and community in individuals with mild to
      moderate Parkinson's disease (PD). Specific aims of the project are to: 1) determine the
      short-term impact of mechanical gait assistance on efficiency and ease of walking in
      individuals with PD, and 2) determine the effect of long-term HWA device usage on the ease
      and ability to walk unassisted in the home and community in individuals with PD.
Difficulties with walking in people with Parkinson's disease contribute to injurious falls
      and decreased quality of life. The Honda Walking Assist (HWA) robotic device is designed to
      assist individuals with gait impairments to take longer strides and walk faster. This study
      will investigate the impact of HWA usage on mobility in the home and community in individuals
      with PD. It will also examine feasibility and safety of HWA usage in the PD population.
      Specific Aim 1: Determine the short-term impact of mechanical gait assistance on efficiency
      and ease of walking in individuals with PD. With disease progression, individuals with PD
      develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased
      step-to-step variability, and freezing of gait), that interfere with their abilities to
      perform daily living tasks and participate in work, home, and social activities and
      predispose them to falls. The investigators hypothesize that wearing the HWA device will
      improve gait efficiency, gait parameters, and perceived ease of walking in individuals with
      PD compared to unassisted walking over a one session period. Specific Aim 2: Determine the
      effect of long-term HWA device usage on the ease and ability to walk unassisted in the home
      and community in individuals with PD. Angular sensors embedded in the HWA monitor the
      cadence, angular velocity, and degree of hip extension and flexion of the device user. When
      the user initiates walking, the HWA automatically adjusts leg movements to reach target walk
      ratios (step length/cadence) by increasing the amount of hip flexion and/or extension using
      power supplied by the device. Thus, the HWA applies continuous, step-by-step cueing to
      individuals with PD to take bigger and more symmetrical steps, thereby producing a faster and
      more efficient walking pattern. By wearing the HWA device over an extended period of time,
      individuals with PD will repetitively practice walking with a more "normal" gait pattern,
      possibly driving neuroplastic changes that will translate to improve unassisted walking. The
      investigators hypothesize that an 8-week intervention of HWA device usage will improve gait
      efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical
      activity in the home and community in individuals with PD with and without the use of the
      device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Gait Velocity
time frame: 8 weeks
description: Walking speed in meters per second
measure: 6-Minute Walk Test
time frame: 8 weeks
description: Distance walked in 6 minutes, reported in meters
measure: Stride Length
time frame: 8 weeks
description: Stride length in centimeters
measure: Double Support Time
time frame: 8 weeks
description: Double support time in seconds
measure: Swing Time - Right Leg
time frame: 8 weeks
description: Swing time in seconds of right leg
measure: Swing Time - Left Leg
time frame: 8 weeks
description: Swing time in seconds of left leg
measure: Double Support Time Coefficient of Variation
time frame: 8 weeks
description: The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
measure: Swing Time Coefficient of Variation of Right Leg
time frame: 8 weeks
description: The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
measure: Swing Time Coefficient of Variation of Left Leg
time frame: 8 weeks
description: The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
measure: Stride Length Coefficient of Variation
time frame: 8 weeks
description: The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
measure: Participants' Perceived Ease of Walking
time frame: 8 weeks
description: Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors "Not at all easy" at 0 on the left end, moderately easy at 5, and "Extremely easy" at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.
measure: Self-Efficacy for Measuring Chronic Disease 6-Item Scale
time frame: 8 weeks
description: Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.
measure: Freezing of Gait Questionnaire
time frame: 8 weeks
description: The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.
measure: Number of Participants With Falls
time frame: 8 weeks
description: Number of participants who recorded falls in a log during the 8-week intervention
arm group label: Walking Training with the HWA Device
arm group type: Experimental
description: Training with HWA device
arm group label: Usual Care
arm group type: Other
description: Usual Care
intervention type: Device
intervention name: Training with HWA device
description: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.
arm group label: Walking Training with the HWA Device
intervention type: Other
intervention name: Usual Care
description: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anne Kloos
role: Principal Investigator
affiliation: Ohio State University
last name: Deb Kegelmeyer
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Anne Kloos
investigator title: Professor-Clinical
mesh term: Parkinson Disease
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 