<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/NCT02968277</url>
  </required_header>
  <id_info>
    <org_study_id>STU00202634</org_study_id>
    <nct_id>NCT02968277</nct_id>
  </id_info>
  <brief_title>LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device</brief_title>
  <official_title>LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to evaluate if the LifeWalker Upright walker is improves&#xD;
      walking and reports of pain compared to a conventional rollator and predicate walker device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LifeWalker Upright is a walker that has been designed to address fall risk, slouching,&#xD;
      and user confidence and comfort. The LifeWalker has adjustable armrests and handles that&#xD;
      enable users to stand tall and look ahead, providing support and stability that is designed&#xD;
      differently than conventional walkers. The LifeWalker Upright's design allows the user to&#xD;
      walk within the walker. This allows people to walk inside the walker as opposed to behind the&#xD;
      walker.&#xD;
&#xD;
      The purpose of this project is to evaluate if the LifeWalker Upright walker is improves&#xD;
      walking and reports of pain compared to a conventional rollator and predicate walker device&#xD;
&#xD;
      Aim 1: Perform in-laboratory training on the Life Walker and testing to compare functional&#xD;
      gait outcomes with the Life Walker compared to a conventional rollator and predicate&#xD;
      assistive mobility device. We expect that participants will be able to walk longer and will&#xD;
      perform more efficiently on measures of gait function when using the Life Walker.&#xD;
&#xD;
      Aim 2: Perform in-laboratory testing to compare self-reported pain with the Life Walker&#xD;
      compared to a conventional rollator and predicate assistive mobility device. We expect that&#xD;
      participants will report less pain because they will have a more efficient and upright&#xD;
      posture when using Life Walker.&#xD;
&#xD;
      Aim 3: Perform in-laboratory testing to compare measures of quality of life with the Life&#xD;
      Walker compared to a conventional rollator and predicate mobility device. We expect that&#xD;
      participants will report better outcomes on quality of life measures because they will&#xD;
      experience better self-esteem due to better mobility when using Life Walker.&#xD;
&#xD;
      Participants will first complete a series of gait testing. Gait testing will include the six&#xD;
      minute walk test and the 10 meter walk test. In addition there will be hand and forearm load&#xD;
      and grip testing using load sensors. Participants will also be asked to be videotaped during&#xD;
      their training sessions. After all the testing is complete, participants will be asked to&#xD;
      complete a set of self-report questionnaires. During each device session, participant heart&#xD;
      rate, blood pressure and blood oxygenation will be measured. All of these procedures will be&#xD;
      repeated with each device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>No washout period between different arms</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minute Walk Test</measure>
    <time_frame>One testing session</time_frame>
    <description>The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10 Meter Walk Test</measure>
    <time_frame>One testing session</time_frame>
    <description>Time to walk 10 meters is measured to calculate gait speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Modified Falls Efficacy Scale (mFES) Score:</measure>
    <time_frame>Baseline score taken at first session</time_frame>
    <description>The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking &quot;how confident are you that you can do the following activities without falling.&quot; Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Pain Scale (VAS)</measure>
    <time_frame>Baseline score taken at first session</time_frame>
    <description>The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read &quot;No pain,&quot; and to the right the description will read &quot;worst pain imaginable.&quot; The individual is instructed to mark a point on the continuum which represents his/her pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Functional Rating Scale</measure>
    <time_frame>One testing session</time_frame>
    <description>Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from &quot;0&quot; (&quot;inability to perform the task&quot;) to &quot;10&quot; (&quot;no difficulty in performing the task.&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Rate of Perceived Exertion</measure>
    <time_frame>One testing session</time_frame>
    <description>The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forearm and Hand Grip</measure>
    <time_frame>One testing session</time_frame>
    <description>Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Started with Forearm Support Walker (LW Upright)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Rollator Walker (Control)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Predicate Device (PD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LifeWalker Upright</intervention_name>
    <description>LifeWalker (LW) upright walker</description>
    <arm_group_label>Predicate Device (PD)</arm_group_label>
    <arm_group_label>Standard Rollator Walker (Control)</arm_group_label>
    <arm_group_label>Started with Forearm Support Walker (LW Upright)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Predicate Device</intervention_name>
    <description>Individual's personal walker</description>
    <arm_group_label>Predicate Device (PD)</arm_group_label>
    <arm_group_label>Standard Rollator Walker (Control)</arm_group_label>
    <arm_group_label>Started with Forearm Support Walker (LW Upright)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Rollator</intervention_name>
    <description>A control rollator device</description>
    <arm_group_label>Predicate Device (PD)</arm_group_label>
    <arm_group_label>Standard Rollator Walker (Control)</arm_group_label>
    <arm_group_label>Started with Forearm Support Walker (LW Upright)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who use a walker due to back pain or adults (over 18) who use a walker for&#xD;
             ambulation.&#xD;
&#xD;
          -  Ages from 18 to 89 years old&#xD;
&#xD;
          -  Medically stable for therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient weight exceeds 300 lbs&#xD;
&#xD;
          -  Patient height is below 5'0&quot; or exceeds 6'3&quot;&#xD;
&#xD;
          -  Inactive, physically unfit to fit into the device.&#xD;
&#xD;
          -  Cognitive deficits or visual impairment that would impair their ability to give&#xD;
             informed consent or to follow simple instructions during the experiments.&#xD;
&#xD;
          -  Mini-Mental State Exam (MMSE) score below 17&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe&#xD;
             ischemia cardiac disease, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>May 22, 2019</results_first_submitted>
  <results_first_submitted_qc>August 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2019</results_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Arun Jayaraman, PT, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02968277/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Started With Forearm Support Walker (LW Upright)</title>
          <description>Data collection began with participants using the LifeWalker Upright walker then the other two walkers in a randomized order</description>
        </group>
        <group group_id="P2">
          <title>Started With Standard Rollator Walker</title>
          <description>Data collection began with participants using a conventional standard rollator (SR) walker then the other two walkers in a randomized order</description>
        </group>
        <group group_id="P3">
          <title>Started With Predicate Device (PD)</title>
          <description>Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Started With Forearm Support Walker (LW Upright)</title>
          <description>Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order</description>
        </group>
        <group group_id="B2">
          <title>Started With Standard Rollator Walker</title>
          <description>Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order</description>
        </group>
        <group group_id="B3">
          <title>Started With Predicate Device (PD)</title>
          <description>Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order</description>
        </group>
        <group group_id="B4">
          <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="10"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="30"/>
          </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="10"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="30"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="12"/>
                  </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="10"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.8" spread="8.2"/>
                    <measurement group_id="B2" value="61.9" spread="11.3"/>
                    <measurement group_id="B3" value="61.9" spread="8.4"/>
                    <measurement group_id="B4" value="62.9" spread="8.9"/>
                  </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="10"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </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 group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" 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="10"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use Walker for Ambulation</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="10"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>6 Minute Walk Test</title>
        <description>The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.</description>
        <time_frame>One testing session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Forearm Support Walker (LW Upright)</title>
            <description>Data collected while participants used the LifeWalker Upright walker.</description>
          </group>
          <group group_id="O2">
            <title>Standard Rollator Walker (Control)</title>
            <description>Data collected while participants used a conventional standard rollator (SR) walker.</description>
          </group>
          <group group_id="O3">
            <title>Predicate Device (PD)</title>
            <description>Data collected while participants used their own rollator walkers.</description>
          </group>
        </group_list>
        <measure>
          <title>6 Minute Walk Test</title>
          <description>The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245.2" spread="19.1"/>
                    <measurement group_id="O2" value="234.7" spread="18.8"/>
                    <measurement group_id="O3" value="233.9" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10 Meter Walk Test</title>
        <description>Time to walk 10 meters is measured to calculate gait speed.</description>
        <time_frame>One testing session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Forearm Support Walker (LW Upright)</title>
            <description>Data collected while participants used the LifeWalker Upright walker.</description>
          </group>
          <group group_id="O2">
            <title>Standard Rollator Walker (Control)</title>
            <description>Data collected while participants used a conventional standard rollator (SR) walker.</description>
          </group>
          <group group_id="O3">
            <title>Predicate Device (PD)</title>
            <description>Data collected while participants used their own rollator walkers.</description>
          </group>
        </group_list>
        <measure>
          <title>10 Meter Walk Test</title>
          <description>Time to walk 10 meters is measured to calculate gait speed.</description>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.06"/>
                    <measurement group_id="O2" value="1.04" spread="0.07"/>
                    <measurement group_id="O3" value="1.01" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Modified Falls Efficacy Scale (mFES) Score:</title>
        <description>The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking &quot;how confident are you that you can do the following activities without falling.&quot; Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.</description>
        <time_frame>Baseline score taken at first session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Started With Forearm Support Walker (LW Upright)</title>
            <description>Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order.</description>
          </group>
          <group group_id="O2">
            <title>Started With Standard Rollator Walker</title>
            <description>Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order.</description>
          </group>
          <group group_id="O3">
            <title>Started With Predicate Device (PD)</title>
            <description>Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Modified Falls Efficacy Scale (mFES) Score:</title>
          <description>The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking &quot;how confident are you that you can do the following activities without falling.&quot; Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.</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="10"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.20" spread="1.6"/>
                    <measurement group_id="O2" value="7.47" spread="0.94"/>
                    <measurement group_id="O3" value="6.19" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Pain Scale (VAS)</title>
        <description>The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read &quot;No pain,&quot; and to the right the description will read &quot;worst pain imaginable.&quot; The individual is instructed to mark a point on the continuum which represents his/her pain.</description>
        <time_frame>Baseline score taken at first session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Started With Forearm Support Walker (LW Upright)</title>
            <description>Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order.</description>
          </group>
          <group group_id="O2">
            <title>Started With Standard Rollator Walker</title>
            <description>Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order.</description>
          </group>
          <group group_id="O3">
            <title>Started With Predicate Device (PD)</title>
            <description>Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Pain Scale (VAS)</title>
          <description>The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read &quot;No pain,&quot; and to the right the description will read &quot;worst pain imaginable.&quot; The individual is instructed to mark a point on the continuum which represents his/her pain.</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="10"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.48" spread="2.4"/>
                    <measurement group_id="O2" value="3.86" spread="2.2"/>
                    <measurement group_id="O3" value="2.77" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>User Functional Rating Scale</title>
        <description>Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from &quot;0&quot; (&quot;inability to perform the task&quot;) to &quot;10&quot; (&quot;no difficulty in performing the task.&quot;).</description>
        <time_frame>One testing session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Forearm Support Walker (LW Upright)</title>
            <description>Data collected while participants used the LifeWalker Upright walker.</description>
          </group>
          <group group_id="O2">
            <title>Standard Rollator Walker (Control)</title>
            <description>Data collected while participants used a conventional standard rollator (SR) walker.</description>
          </group>
          <group group_id="O3">
            <title>Predicate Device (PD)</title>
            <description>Data collected while participants used their own rollator walkers.</description>
          </group>
        </group_list>
        <measure>
          <title>User Functional Rating Scale</title>
          <description>Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from &quot;0&quot; (&quot;inability to perform the task&quot;) to &quot;10&quot; (&quot;no difficulty in performing the task.&quot;).</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="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.17" spread="1.78"/>
                    <measurement group_id="O2" value="8.26" spread="2.07"/>
                    <measurement group_id="O3" value="8.58" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Borg Rate of Perceived Exertion</title>
        <description>The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.</description>
        <time_frame>One testing session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Forearm Support Walker (LW Upright)</title>
            <description>Data collected while participants used the LifeWalker Upright walker.</description>
          </group>
          <group group_id="O2">
            <title>Standard Rollator Walker (Control)</title>
            <description>Data collected while participants used a conventional standard rollator (SR) walker.</description>
          </group>
          <group group_id="O3">
            <title>Predicate Device (PD)</title>
            <description>Data collected while participants used their own rollator walkers.</description>
          </group>
        </group_list>
        <measure>
          <title>Borg Rate of Perceived Exertion</title>
          <description>The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="0.57"/>
                    <measurement group_id="O2" value="14.1" spread="0.64"/>
                    <measurement group_id="O3" value="14.1" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forearm and Hand Grip</title>
        <description>Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.</description>
        <time_frame>One testing session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Forearm Support Walker (LW Upright)</title>
            <description>Data collected while participants used the LifeWalker Upright walker.</description>
          </group>
          <group group_id="O2">
            <title>Standard Rollator Walker (Control)</title>
            <description>Data collected while participants used a conventional standard rollator (SR) walker.</description>
          </group>
          <group group_id="O3">
            <title>Predicate Device (PD)</title>
            <description>Data collected while participants used their own rollator walkers.</description>
          </group>
        </group_list>
        <measure>
          <title>Forearm and Hand Grip</title>
          <description>Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="0.9"/>
                    <measurement group_id="O2" value="5.8" spread="1.05"/>
                    <measurement group_id="O3" value="5.7" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored/assessed, during every data collection session, through study completion, an average of 2 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Forearm Support Walker (LW Upright)</title>
          <description>This arm reflects time during which participants were using the LifeWalker Upright walker</description>
        </group>
        <group group_id="E2">
          <title>Standard Rollator (Control)</title>
          <description>This arm reflects time during which participants were using a standard rollator walker</description>
        </group>
        <group group_id="E3">
          <title>Predicate Device (PD)</title>
          <description>This arm reflects time during which participants were using their own rollator walkers</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All assessments were done on level ground surfaces, all tests were done in controlled, clinical environment. Long term effects of using LifeWalker could not be determined in this study. The pathological demographic of the study sample was diverse.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes</name_or_title>
      <organization>Rehabilitation Institute of Chicago</organization>
      <phone>3122386875</phone>
      <email>ajayaraman@ricres.org</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/NCT02968277
org study id: STU00202634
nct id: NCT02968277
lead sponsor: 
has dmc: No
The purpose of this project is to evaluate if the LifeWalker Upright walker is improves
      walking and reports of pain compared to a conventional rollator and predicate walker device.
The LifeWalker Upright is a walker that has been designed to address fall risk, slouching,
      and user confidence and comfort. The LifeWalker has adjustable armrests and handles that
      enable users to stand tall and look ahead, providing support and stability that is designed
      differently than conventional walkers. The LifeWalker Upright's design allows the user to
      walk within the walker. This allows people to walk inside the walker as opposed to behind the
      walker.

      The purpose of this project is to evaluate if the LifeWalker Upright walker is improves
      walking and reports of pain compared to a conventional rollator and predicate walker device

      Aim 1: Perform in-laboratory training on the Life Walker and testing to compare functional
      gait outcomes with the Life Walker compared to a conventional rollator and predicate
      assistive mobility device. We expect that participants will be able to walk longer and will
      perform more efficiently on measures of gait function when using the Life Walker.

      Aim 2: Perform in-laboratory testing to compare self-reported pain with the Life Walker
      compared to a conventional rollator and predicate assistive mobility device. We expect that
      participants will report less pain because they will have a more efficient and upright
      posture when using Life Walker.

      Aim 3: Perform in-laboratory testing to compare measures of quality of life with the Life
      Walker compared to a conventional rollator and predicate mobility device. We expect that
      participants will report better outcomes on quality of life measures because they will
      experience better self-esteem due to better mobility when using Life Walker.

      Participants will first complete a series of gait testing. Gait testing will include the six
      minute walk test and the 10 meter walk test. In addition there will be hand and forearm load
      and grip testing using load sensors. Participants will also be asked to be videotaped during
      their training sessions. After all the testing is complete, participants will be asked to
      complete a set of self-report questionnaires. During each device session, participant heart
      rate, blood pressure and blood oxygenation will be measured. All of these procedures will be
      repeated with each device.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: No washout period between different arms
primary purpose: Supportive Care
masking: None (Open Label)
measure: 6 Minute Walk Test
time frame: One testing session
description: The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.
measure: 10 Meter Walk Test
time frame: One testing session
description: Time to walk 10 meters is measured to calculate gait speed.
measure: Baseline Modified Falls Efficacy Scale (mFES) Score:
time frame: Baseline score taken at first session
description: The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling." Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.
measure: Visual Analog Pain Scale (VAS)
time frame: Baseline score taken at first session
description: The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read "No pain," and to the right the description will read "worst pain imaginable." The individual is instructed to mark a point on the continuum which represents his/her pain.
measure: User Functional Rating Scale
time frame: One testing session
description: Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from "0" ("inability to perform the task") to "10" ("no difficulty in performing the task.").
measure: Borg Rate of Perceived Exertion
time frame: One testing session
description: The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.
measure: Forearm and Hand Grip
time frame: One testing session
description: Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.
arm group label: Started with Forearm Support Walker (LW Upright)
arm group type: Experimental
description: Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
arm group label: Standard Rollator Walker (Control)
arm group type: Experimental
description: Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
arm group label: Predicate Device (PD)
arm group type: Experimental
description: Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
intervention type: Device
intervention name: LifeWalker Upright
description: LifeWalker (LW) upright walker
arm group label: Predicate Device (PD)
arm group label: Standard Rollator Walker (Control)
arm group label: Started with Forearm Support Walker (LW Upright)
intervention type: Device
intervention name: Predicate Device
description: Individual's personal walker
arm group label: Predicate Device (PD)
arm group label: Standard Rollator Walker (Control)
arm group label: Started with Forearm Support Walker (LW Upright)
intervention type: Device
intervention name: Standard Rollator
description: A control rollator device
arm group label: Predicate Device (PD)
arm group label: Standard Rollator Walker (Control)
arm group label: Started with Forearm Support Walker (LW Upright)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Arun Jayaraman, PT, PhD
investigator title: Principal Investigator
mesh term: Back Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All assessments were done on level ground surfaces, all tests were done in controlled, clinical environment. Long term effects of using LifeWalker could not be determined in this study. The pathological demographic of the study sample was diverse.
point of contact: 