<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/NCT02185404</url>
  </required_header>
  <id_info>
    <org_study_id>Moterum-GEMS</org_study_id>
    <nct_id>NCT02185404</nct_id>
  </id_info>
  <brief_title>iStride(TM) Device Used for Stroke Rehabilitation</brief_title>
  <official_title>iStride(TM) Device Used for Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Moterum Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research is to test a passive shoe to correct gait in individuals with&#xD;
      asymmetric walking patterns. This will be done in a clinic. Individuals with central nervous&#xD;
      system damage, such as stroke, often have irregular walking patterns and have difficulty&#xD;
      walking correctly. Recent research has shown that using a split-belt treadmill can create&#xD;
      after-effects that temporarily correct the inefficient walking patterns. However, the&#xD;
      corrected walking pattern does not efficiently transfer from the treadmill to walking over&#xD;
      ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a&#xD;
      patient to practice walking in many different locations, such as their own home, which we&#xD;
      hypothesize will result in a more permanent transfer of learned gait patterns. To enable&#xD;
      long-term use, our proposed shoe design is passive and uses the wearer's natural forces&#xD;
      exerted while walking to generate the necessary motions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemiparesis and other impairments are a frequent and disabling consequence of stroke and can&#xD;
      lead to asymmetric and inefficient walking patterns. Training on a split-belt treadmill,&#xD;
      which has two separate treads driving each leg at a different speed, can correct gait&#xD;
      asymmetries post-stroke. However, the effects of split-belt treadmill training only partially&#xD;
      transfer to everyday walking over ground and extended training sessions are required to&#xD;
      achieve long-lasting effects. Our previous studies suggest that the iStride device that has&#xD;
      been developed in our laboratory can be used as an alternative gait training device for&#xD;
      people with stroke. The iStride device mimics the actions of the split-belt treadmill, but&#xD;
      can be used during over-ground walking and in one's own home, thus enabling long-term&#xD;
      training. The iStride device does not require any external power and is completely passive;&#xD;
      all necessary forces are redirected from the natural forces present during walking since it&#xD;
      utilizes the wearer's weight to generate its movements. While the movements of the iStride&#xD;
      device are similar to the split belt treadmill, and the iStride device generates a similar&#xD;
      aftereffect, the efficacy of this shoe in modifying the gait of an individual with stroke is&#xD;
      not yet verified.&#xD;
&#xD;
      In this study, we will test the efficacy of the iStride device on individuals with stroke in&#xD;
      the clinic. Efficacy will be evaluated based on the change in gait coordination and also&#xD;
      based on subjects' self-reported comfort on the device. We predict that the iStride device&#xD;
      will result in changes to interlimb coordination of gait that could be a safe and effective&#xD;
      device to be used in ones' home.&#xD;
&#xD;
      The asymmetric nature of hemiparetic gait can have a large impact on functional walking&#xD;
      ability. For example, swing phase asymmetry is a significant predictor of hemiparetic walking&#xD;
      performance because it strongly correlates with stages of motor recovery, walking speed, and&#xD;
      falls. Another measure of temporal asymmetry - double support duration - is similarly&#xD;
      correlated with walking speed. In addition, spatial (e.g. step length) asymmetry is&#xD;
      associated with decreased propulsive force on the paretic leg, which limits forward motion of&#xD;
      the body and reduces gait efficiency. The importance of gait efficiency should not be&#xD;
      understated - the elevated energy demands of hemiparetic gait combined with physical&#xD;
      deconditioning post-stroke can greatly limit performance of activities of daily living,&#xD;
      contributing to poor cardiovascular fitness and metabolic syndrome. In turn, this can&#xD;
      increase the risks of a second stroke or cardiovascular event and is associated with&#xD;
      increased morbidity and mortality rates. Therefore, improving gait symmetry should be an&#xD;
      important goal for therapy, to not only improve functional mobility and reduce injury, but&#xD;
      also to enhance general health and well-being post-stroke.&#xD;
&#xD;
      Practicing walking on a split-belt treadmill can correct abnormal interlimb coordination of&#xD;
      gait in individuals with hemiparesis following stroke or other central nervous system&#xD;
      lesions. Asymmetric gait can manifest as a spatial asymmetry, in which steps taken on one&#xD;
      side are longer than those on the other. It can also manifest as a temporal asymmetry, where&#xD;
      the timing is uneven on the paretic and non-paretic sides. Temporal asymmetries are often&#xD;
      measured as differences in the duration of double support periods, which are the amount of&#xD;
      time both feet are simultaneously contacting the ground and are measured separately for the&#xD;
      paretic and non-paretic sides. The iStride device is designed to cause changes in both&#xD;
      spatial and temporal gait symmetry. We predict that the iStride device would cause the steps&#xD;
      on the side with the iStride device to be larger since individuals would compensate for the&#xD;
      backward rolling motion by placing their foot farther forward in stance, thus increasing the&#xD;
      distance between the two feet. Similarly, since the stride is longer, it may also shorten the&#xD;
      duration of stance relative to the other side. With shortened stance duration, the amount of&#xD;
      time spent in double-support at the end of stance would likely decrease as well.&#xD;
&#xD;
      Although the original idea of the iStride device is derived from the motion of the&#xD;
      split-belt-treadmill, there are distinct differences between walking on the device and&#xD;
      walking on a split-belt treadmill with asymmetric belt velocities. While the body's velocity&#xD;
      relative to ground is zero on a split-belt treadmill, the relative velocity of the iStride&#xD;
      device is non-zero and forward. The device forces the wearer's foot forward or backward&#xD;
      whereas the treadmill moves both feet backward, but at different speeds. For both the&#xD;
      split-belt treadmill and the iStride device, the relative velocity between both feet is&#xD;
      similar and the backward-moving iStride device takes the place of the faster tread.&#xD;
&#xD;
      We hypothesize that training over ground will lead to a change in the interlimb coordination&#xD;
      in individuals with asymmetric gait and allow individuals to develop a more persistent&#xD;
      symmetric gait. There are several differences between training on ground and a treadmill,&#xD;
      such as visual flow and vestibular information signaling forward movement that likely limit&#xD;
      the expression of learning in the over-ground context when trained on a treadmill. Visual&#xD;
      cues appear to be particularly important for context awareness. Visual cues, coupled with&#xD;
      prior experience, are so powerful that predictive postural responses cause an individual to&#xD;
      stumble when stepping onto an escalator that is not moving. The body has learned an internal&#xD;
      model that expects an acceleration when stepping onto an escalator, but when that&#xD;
      acceleration does not occur, the person stumbles. A study of split-belt walking showed that&#xD;
      transfer to over-ground walking is enhanced when subjects are blindfolded during training on&#xD;
      the treadmill and tested over ground. Since blindfolding eliminates visual cues about the&#xD;
      environment, this also suggests that vision is a key factor in determining the&#xD;
      context-dependence of learning. Since it is not realistic to blindfold stroke patients during&#xD;
      gait training, we designed the iStride device so that training could occur during over-ground&#xD;
      walking, thus visual cues during training and later walking over ground would be the same.&#xD;
&#xD;
      Data from control subjects using an earlier version of the iStride device (referred to as&#xD;
      GEMS at the time) has been published and a video of this previous version can be found at&#xD;
      http://reedlab.eng.usf.edu/publications/handzic2011GEMS.mp4. In this study, we found that&#xD;
      this earlier version of the device was capable of changing step length as predicted, however&#xD;
      the previous design was too heavy and too tall to be considered practical for testing in&#xD;
      stroke populations. The current version of the iStride device produces similar motion to the&#xD;
      previous version, but it weighs less (under 1 kg) and is shorter (~4.4 cm). We will test the&#xD;
      efficacy of wearing the current iStride device on gait coordination during walking over&#xD;
      ground on individuals with stroke in the clinic. All walking will be performed while subjects&#xD;
      are closely guarded by an experienced physical therapist to prevent falling. The effects of&#xD;
      the iStride device on gait coordination will be compared to those induced on a split-belt&#xD;
      treadmill.&#xD;
&#xD;
      The proposed project represents one of the first attempts to build a device that corrects&#xD;
      walking symmetry while walking over ground. Not only would this allow people to experience&#xD;
      gait corrections while performing normal movements, but the simplicity and relative low cost&#xD;
      of these devices would also open up potential opportunities to train at home (for&#xD;
      high-functioning individuals with supervision) and in clinics where a split-belt treadmill is&#xD;
      not available. The studies outlined here will establish whether the iStride device is capable&#xD;
      of changing interlimb coordination of gait, and whether individuals with stroke can use these&#xD;
      devices for rehabilitation purposes. This work will thus build the foundation for future&#xD;
      training studies examining the effectiveness of long-term use of the iStride device for&#xD;
      improving symmetric walking patterns.&#xD;
&#xD;
      The question that this study targets is the modification of human walking patterns for use in&#xD;
      stroke rehabilitation. It is our ultimate objective to show that the iStride device can&#xD;
      change a person's temporal and spatial gait asymmetry into a symmetric gait. Our points of&#xD;
      reference are results obtained by previous studies with split-belt treadmills. We are also&#xD;
      interested in how altering the interface between a foot and the ground influences the&#xD;
      adaptation to new walking patterns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2016</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change in Step Length Asymmetry</measure>
    <time_frame>Baseline assessment at start and at conclusion of training</time_frame>
    <description>During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage Change in Double Support Asymmetry</measure>
    <time_frame>Baseline assessment at start and at conclusion of training</time_frame>
    <description>We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>wearing the iStride device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>wearing the iStride device</intervention_name>
    <description>The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.</description>
    <arm_group_label>wearing the iStride device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 21-80&#xD;
&#xD;
          -  one or more cerebral strokes, but all strokes on same side&#xD;
&#xD;
          -  a stroke at least 6 months prior to enrollment&#xD;
&#xD;
          -  Gait asymmetry, but able to walk independently with or without a cane&#xD;
&#xD;
          -  Not currently receiving physical therapy&#xD;
&#xD;
          -  no evidence of severe cognitive impairment that would interfere with understanding the&#xD;
             instructions&#xD;
&#xD;
          -  no evidence of one-sided neglect, affecting ambulation&#xD;
&#xD;
          -  At least 25 feet of walking space in home (does not need to be a straight line)&#xD;
&#xD;
          -  Weight does not exceed 250 lbs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled seizures&#xD;
&#xD;
          -  metal implants (stents, clips, pacemaker)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  History of a neurological disorder other than stroke ( Parkinson's, MS)&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease&#xD;
&#xD;
          -  Uncontrolled blood pressure&#xD;
&#xD;
          -  Head injury in the past 90 days&#xD;
&#xD;
          -  A myocardial infarction within the last 180 days&#xD;
&#xD;
          -  Cannot rely on a rolling walker for ambulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle B Reed, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://reedlab.eng.usf.edu/iStrideDevice/</url>
    <description>Research related to the iStride(TM) Device</description>
  </link>
  <link>
    <url>https://moterum.com/relearn-to-walk/</url>
    <description>Commercial information about the iStride(TM) Device</description>
  </link>
  <reference>
    <citation>Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4):10.2478/s13230-012-0010-7. doi: 10.2478/s13230-012-0010-7.</citation>
    <PMID>24371521</PMID>
  </reference>
  <reference>
    <citation>Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. doi: 10.1109/ICRA.2012.6225346.</citation>
    <PMID>23484067</PMID>
  </reference>
  <results_reference>
    <citation>Kim S, Handzic I, Huizenga D, Edgeworth R, Lozinski M, Ramakrishnan T, &amp; Reed KB,&quot; Initial Results of the Gait Enhancing Mobile Shoe on Individuals with Stroke&quot; 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), August 2016.</citation>
  </results_reference>
  <results_reference>
    <citation>Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x.</citation>
    <PMID>31455358</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>September 1, 2020</results_first_submitted>
  <results_first_submitted_qc>July 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02185404/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wearing the iStride Device</title>
          <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wearing the iStride Device</title>
          <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.7" spread="6.9"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years Post Stroke</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.8" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change in Step Length Asymmetry</title>
        <description>During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
        <time_frame>Baseline assessment at start and at conclusion of training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wearing the iStride Device</title>
            <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Step Length Asymmetry</title>
          <description>During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
          <units>% change in asymmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change in Double Support Asymmetry</title>
        <description>We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
        <time_frame>Baseline assessment at start and at conclusion of training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wearing the iStride Device</title>
            <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Double Support Asymmetry</title>
          <description>We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.</description>
          <units>% change in asymmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="9.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year, 11 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wearing the iStride Device</title>
          <description>The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.</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="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kyle B. Reed</name_or_title>
      <organization>University of South Florida</organization>
      <phone>813-974-2385</phone>
      <email>kylereed@usf.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/NCT02185404
org study id: Moterum-GEMS
nct id: NCT02185404
lead sponsor: 
collaborator: 
has dmc: No
The objective of this research is to test a passive shoe to correct gait in individuals with
      asymmetric walking patterns. This will be done in a clinic. Individuals with central nervous
      system damage, such as stroke, often have irregular walking patterns and have difficulty
      walking correctly. Recent research has shown that using a split-belt treadmill can create
      after-effects that temporarily correct the inefficient walking patterns. However, the
      corrected walking pattern does not efficiently transfer from the treadmill to walking over
      ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a
      patient to practice walking in many different locations, such as their own home, which we
      hypothesize will result in a more permanent transfer of learned gait patterns. To enable
      long-term use, our proposed shoe design is passive and uses the wearer's natural forces
      exerted while walking to generate the necessary motions.
Hemiparesis and other impairments are a frequent and disabling consequence of stroke and can
      lead to asymmetric and inefficient walking patterns. Training on a split-belt treadmill,
      which has two separate treads driving each leg at a different speed, can correct gait
      asymmetries post-stroke. However, the effects of split-belt treadmill training only partially
      transfer to everyday walking over ground and extended training sessions are required to
      achieve long-lasting effects. Our previous studies suggest that the iStride device that has
      been developed in our laboratory can be used as an alternative gait training device for
      people with stroke. The iStride device mimics the actions of the split-belt treadmill, but
      can be used during over-ground walking and in one's own home, thus enabling long-term
      training. The iStride device does not require any external power and is completely passive;
      all necessary forces are redirected from the natural forces present during walking since it
      utilizes the wearer's weight to generate its movements. While the movements of the iStride
      device are similar to the split belt treadmill, and the iStride device generates a similar
      aftereffect, the efficacy of this shoe in modifying the gait of an individual with stroke is
      not yet verified.

      In this study, we will test the efficacy of the iStride device on individuals with stroke in
      the clinic. Efficacy will be evaluated based on the change in gait coordination and also
      based on subjects' self-reported comfort on the device. We predict that the iStride device
      will result in changes to interlimb coordination of gait that could be a safe and effective
      device to be used in ones' home.

      The asymmetric nature of hemiparetic gait can have a large impact on functional walking
      ability. For example, swing phase asymmetry is a significant predictor of hemiparetic walking
      performance because it strongly correlates with stages of motor recovery, walking speed, and
      falls. Another measure of temporal asymmetry - double support duration - is similarly
      correlated with walking speed. In addition, spatial (e.g. step length) asymmetry is
      associated with decreased propulsive force on the paretic leg, which limits forward motion of
      the body and reduces gait efficiency. The importance of gait efficiency should not be
      understated - the elevated energy demands of hemiparetic gait combined with physical
      deconditioning post-stroke can greatly limit performance of activities of daily living,
      contributing to poor cardiovascular fitness and metabolic syndrome. In turn, this can
      increase the risks of a second stroke or cardiovascular event and is associated with
      increased morbidity and mortality rates. Therefore, improving gait symmetry should be an
      important goal for therapy, to not only improve functional mobility and reduce injury, but
      also to enhance general health and well-being post-stroke.

      Practicing walking on a split-belt treadmill can correct abnormal interlimb coordination of
      gait in individuals with hemiparesis following stroke or other central nervous system
      lesions. Asymmetric gait can manifest as a spatial asymmetry, in which steps taken on one
      side are longer than those on the other. It can also manifest as a temporal asymmetry, where
      the timing is uneven on the paretic and non-paretic sides. Temporal asymmetries are often
      measured as differences in the duration of double support periods, which are the amount of
      time both feet are simultaneously contacting the ground and are measured separately for the
      paretic and non-paretic sides. The iStride device is designed to cause changes in both
      spatial and temporal gait symmetry. We predict that the iStride device would cause the steps
      on the side with the iStride device to be larger since individuals would compensate for the
      backward rolling motion by placing their foot farther forward in stance, thus increasing the
      distance between the two feet. Similarly, since the stride is longer, it may also shorten the
      duration of stance relative to the other side. With shortened stance duration, the amount of
      time spent in double-support at the end of stance would likely decrease as well.

      Although the original idea of the iStride device is derived from the motion of the
      split-belt-treadmill, there are distinct differences between walking on the device and
      walking on a split-belt treadmill with asymmetric belt velocities. While the body's velocity
      relative to ground is zero on a split-belt treadmill, the relative velocity of the iStride
      device is non-zero and forward. The device forces the wearer's foot forward or backward
      whereas the treadmill moves both feet backward, but at different speeds. For both the
      split-belt treadmill and the iStride device, the relative velocity between both feet is
      similar and the backward-moving iStride device takes the place of the faster tread.

      We hypothesize that training over ground will lead to a change in the interlimb coordination
      in individuals with asymmetric gait and allow individuals to develop a more persistent
      symmetric gait. There are several differences between training on ground and a treadmill,
      such as visual flow and vestibular information signaling forward movement that likely limit
      the expression of learning in the over-ground context when trained on a treadmill. Visual
      cues appear to be particularly important for context awareness. Visual cues, coupled with
      prior experience, are so powerful that predictive postural responses cause an individual to
      stumble when stepping onto an escalator that is not moving. The body has learned an internal
      model that expects an acceleration when stepping onto an escalator, but when that
      acceleration does not occur, the person stumbles. A study of split-belt walking showed that
      transfer to over-ground walking is enhanced when subjects are blindfolded during training on
      the treadmill and tested over ground. Since blindfolding eliminates visual cues about the
      environment, this also suggests that vision is a key factor in determining the
      context-dependence of learning. Since it is not realistic to blindfold stroke patients during
      gait training, we designed the iStride device so that training could occur during over-ground
      walking, thus visual cues during training and later walking over ground would be the same.

      Data from control subjects using an earlier version of the iStride device (referred to as
      GEMS at the time) has been published and a video of this previous version can be found at
      http://reedlab.eng.usf.edu/publications/handzic2011GEMS.mp4. In this study, we found that
      this earlier version of the device was capable of changing step length as predicted, however
      the previous design was too heavy and too tall to be considered practical for testing in
      stroke populations. The current version of the iStride device produces similar motion to the
      previous version, but it weighs less (under 1 kg) and is shorter (~4.4 cm). We will test the
      efficacy of wearing the current iStride device on gait coordination during walking over
      ground on individuals with stroke in the clinic. All walking will be performed while subjects
      are closely guarded by an experienced physical therapist to prevent falling. The effects of
      the iStride device on gait coordination will be compared to those induced on a split-belt
      treadmill.

      The proposed project represents one of the first attempts to build a device that corrects
      walking symmetry while walking over ground. Not only would this allow people to experience
      gait corrections while performing normal movements, but the simplicity and relative low cost
      of these devices would also open up potential opportunities to train at home (for
      high-functioning individuals with supervision) and in clinics where a split-belt treadmill is
      not available. The studies outlined here will establish whether the iStride device is capable
      of changing interlimb coordination of gait, and whether individuals with stroke can use these
      devices for rehabilitation purposes. This work will thus build the foundation for future
      training studies examining the effectiveness of long-term use of the iStride device for
      improving symmetric walking patterns.

      The question that this study targets is the modification of human walking patterns for use in
      stroke rehabilitation. It is our ultimate objective to show that the iStride device can
      change a person's temporal and spatial gait asymmetry into a symmetric gait. Our points of
      reference are results obtained by previous studies with split-belt treadmills. We are also
      interested in how altering the interface between a foot and the ground influences the
      adaptation to new walking patterns.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage Change in Step Length Asymmetry
time frame: Baseline assessment at start and at conclusion of training
description: During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.
measure: Percentage Change in Double Support Asymmetry
time frame: Baseline assessment at start and at conclusion of training
description: We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.
arm group label: wearing the iStride device
arm group type: Experimental
description: The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
intervention type: Device
intervention name: wearing the iStride device
description: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
arm group label: wearing the iStride device
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kyle B Reed, Ph.D.
role: Principal Investigator
affiliation: University of South Florida
facility: 
country: United States
url: http://reedlab.eng.usf.edu/iStrideDevice/
description: Research related to the iStride(TM) Device
url: https://moterum.com/relearn-to-walk/
description: Commercial information about the iStride(TM) Device
citation: Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4):10.2478/s13230-012-0010-7. doi: 10.2478/s13230-012-0010-7.
PMID: 24371521
citation: Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. doi: 10.1109/ICRA.2012.6225346.
PMID: 23484067
citation: Kim S, Handzic I, Huizenga D, Edgeworth R, Lozinski M, Ramakrishnan T, & Reed KB," Initial Results of the Gait Enhancing Mobile Shoe on Individuals with Stroke" 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), August 2016.
citation: Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x.
PMID: 31455358
responsible party type: Sponsor
mesh term: Stroke
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 