<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/NCT01726998</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0005</org_study_id>
    <nct_id>NCT01726998</nct_id>
  </id_info>
  <brief_title>Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted&#xD;
      locomotor training on motor recovery of lower extremities and walking ability compared with&#xD;
      the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.&#xD;
&#xD;
      72 first-ever stroke patients who could not walk independently (FAC &lt; 2), and suffered within&#xD;
      6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive&#xD;
      heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk&#xD;
      independently before stroke attack were excluded.&#xD;
&#xD;
      Two groups received 30 minutes conventional gait training including Neurodevelopmental&#xD;
      Treatment (NDT) basically. The robotic assisted locomotor training group received additional&#xD;
      robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily&#xD;
      for 4 weeks, and the conventional gait training group received additional daily conventional&#xD;
      gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3),&#xD;
      Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA),&#xD;
      Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles&#xD;
      were assessed before, during (2weeks) and after training. And the independent walking ability&#xD;
      were followed until 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of functional ambulation category point</measure>
    <time_frame>baseline, during training (2weeks), post training (4weeks) &amp; followed for 2months after training</time_frame>
    <description>FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparetic Patients After Subacute Stroke</condition>
  <arm_group>
    <arm_group_label>Lokomat Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional gait training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Robot-assisted gait therapy</intervention_name>
    <description>Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.</description>
    <arm_group_label>Lokomat Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional gait training</intervention_name>
    <description>Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.</description>
    <arm_group_label>conventional gait training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hemiparesis as result of 1st stroke&#xD;
&#xD;
          2. No other neurologic or orthopedic disorder&#xD;
&#xD;
          3. Independent ambulation before the stroke&#xD;
&#xD;
          4. No severe medical illnesses&#xD;
&#xD;
          5. Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups&#xD;
&#xD;
          6. Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal&#xD;
             assistance in ambulation&#xD;
&#xD;
          7. The interval between stroke and start of the treatment&#xD;
&#xD;
          8. Time since stroke onset &lt; 6 months&#xD;
&#xD;
          9. age: 20-80yrs old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable fractures&#xD;
&#xD;
          2. Severe osteoporosis&#xD;
&#xD;
          3. Severe skin problems&#xD;
&#xD;
          4. Severe joint problems&#xD;
&#xD;
          5. Major difference in leg length,&#xD;
&#xD;
          6. Body weight over 130 kg,&#xD;
&#xD;
          7. Orthostatic circulatory problem&#xD;
&#xD;
          8. Severe cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</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>
  <!-- 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/NCT01726998
org study id: 4-2012-0005
nct id: NCT01726998
lead sponsor: 
has dmc: No
The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted
      locomotor training on motor recovery of lower extremities and walking ability compared with
      the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.

      72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within
      6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive
      heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk
      independently before stroke attack were excluded.

      Two groups received 30 minutes conventional gait training including Neurodevelopmental
      Treatment (NDT) basically. The robotic assisted locomotor training group received additional
      robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily
      for 4 weeks, and the conventional gait training group received additional daily conventional
      gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3),
      Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA),
      Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles
      were assessed before, during (2weeks) and after training. And the independent walking ability
      were followed until 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of functional ambulation category point
time frame: baseline, during training (2weeks), post training (4weeks) & followed for 2months after training
description: FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.
arm group label: Lokomat Group
arm group type: Experimental
arm group label: conventional gait training group
arm group type: Active Comparator
intervention type: Other
intervention name: Robot-assisted gait therapy
description: Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
arm group label: Lokomat Group
intervention type: Other
intervention name: conventional gait training
description: Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
arm group label: conventional gait training group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke