<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/NCT02189551</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ: 2014-052</org_study_id>
    <nct_id>NCT02189551</nct_id>
  </id_info>
  <brief_title>Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System</brief_title>
  <acronym>LOKOMAT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Cereneo AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Commission for Technology and Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hocoma AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cereneo AG</source>
  <brief_summary>
    <textblock>
      The objective of the study is to compare a new medical devices with an established medical&#xD;
      device for lower limb rehabilitation regarding training outcome and patient comfort / patient&#xD;
      satisfaction (primary objective) and treatment effect (exploratory objective).&#xD;
&#xD;
      Primary study endpoints will be a significantly higher rated patient comfort and or patient&#xD;
      satisfaction using the new versions, compared with the established Lokomat. Furthermore,&#xD;
      muscle activity and kinematic movement patterns will be expected to show more involved muscle&#xD;
      groups and a walking pattern involving more degrees of freedom during use of the new version&#xD;
      compared with the established Lokomat.&#xD;
&#xD;
      Exploratory endpoints will be a significantly stronger involvement of muscles needed for&#xD;
      balance, more physiological walking patterns and more change on the lateral positioning of&#xD;
      the feet due to training with the new version, compared with the established Lokomat.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    an additional intervention, amendet to the study (3rd arm, not described here), has not&#xD;
    received clearance by regulatory authorities&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lateral hip movement</measure>
    <time_frame>30 min training during day 1 (next session after inclusion)</time_frame>
    <description>during 30 min training with each device, lateral hip movements will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>day 2 and 3</time_frame>
    <description>Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient motivation</measure>
    <time_frame>day 2 and 3</time_frame>
    <description>Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Post Stroke Gait Training</condition>
  <arm_group>
    <arm_group_label>Lokomat Pro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gait robot established on the market</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lokomat Pro FreeD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gait training with Lokomat Pro</intervention_name>
    <arm_group_label>Lokomat Pro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gait training with Lokomat Pro FreeD</intervention_name>
    <arm_group_label>Lokomat Pro FreeD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lower extremity weakness due to stroke&#xD;
&#xD;
          -  minor functional impairment (MRC &lt; 5)&#xD;
&#xD;
          -  ability and willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe spasticity of the lower extremities&#xD;
&#xD;
          -  severe dementia&#xD;
&#xD;
          -  severe depression&#xD;
&#xD;
          -  any other contraindications against Lokomat training&#xD;
&#xD;
          -  body weight &gt; 135 kg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cereneo, Center For Rehabilitation and Neurology</name>
      <address>
        <city>Vitznau</city>
        <state>LU</state>
        <zip>6354</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02189551
org study id: EKNZ: 2014-052
nct id: NCT02189551
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The objective of the study is to compare a new medical devices with an established medical
      device for lower limb rehabilitation regarding training outcome and patient comfort / patient
      satisfaction (primary objective) and treatment effect (exploratory objective).

      Primary study endpoints will be a significantly higher rated patient comfort and or patient
      satisfaction using the new versions, compared with the established Lokomat. Furthermore,
      muscle activity and kinematic movement patterns will be expected to show more involved muscle
      groups and a walking pattern involving more degrees of freedom during use of the new version
      compared with the established Lokomat.

      Exploratory endpoints will be a significantly stronger involvement of muscles needed for
      balance, more physiological walking patterns and more change on the lateral positioning of
      the feet due to training with the new version, compared with the established Lokomat.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Lateral hip movement
time frame: 30 min training during day 1 (next session after inclusion)
description: during 30 min training with each device, lateral hip movements will be assessed
measure: Patient satisfaction
time frame: day 2 and 3
description: Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
measure: Patient motivation
time frame: day 2 and 3
description: Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
arm group label: Lokomat Pro
arm group type: Active Comparator
description: gait robot established on the market
arm group label: Lokomat Pro FreeD
arm group type: Experimental
description: gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market
intervention type: Behavioral
intervention name: Gait training with Lokomat Pro
arm group label: Lokomat Pro
intervention type: Behavioral
intervention name: Gait training with Lokomat Pro FreeD
arm group label: Lokomat Pro FreeD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor