<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/NCT03767205</url>
  </required_header>
  <id_info>
    <org_study_id>2018-06-128</org_study_id>
    <nct_id>NCT03767205</nct_id>
  </id_info>
  <brief_title>The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients</brief_title>
  <official_title>The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to identify the assistance effect of Ankle Assist Robot v1&#xD;
      developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea)&#xD;
      by comparing&#xD;
&#xD;
        1. gait function during overground gait in three conditions (with robot-assist torque&#xD;
           on/with robot-assist torque off/without robot)&#xD;
&#xD;
        2. the energy expenditure during treadmill gait in three conditions (with robot-assist&#xD;
           torque on/with robot-assist torque off/without robot)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on gait speed in different three conditions</measure>
    <time_frame>20minutes</time_frame>
    <description>All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on gait function in different three conditions (kinematic)</measure>
    <time_frame>20minutes</time_frame>
    <description>All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on gait function in different three conditions (kinetic)</measure>
    <time_frame>20minutes</time_frame>
    <description>All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on gait function in different three conditions (muscle activation)</measure>
    <time_frame>20minutes</time_frame>
    <description>All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on metabolic energy expenditure in different three conditions</measure>
    <time_frame>1 hour</time_frame>
    <description>All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Stroke</condition>
  <condition>Gait, Hemiplegic</condition>
  <arm_group>
    <arm_group_label>stroke patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ankle Assist Robot</intervention_name>
    <description>overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate&#xD;
treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).</description>
    <arm_group_label>stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke patients with hemiplegia over 19 years old&#xD;
&#xD;
          -  Ischemic or hemorrhagic stroke patients over 3 months of onset&#xD;
&#xD;
          -  Functional Ambulation Category Scale with 3 or more scales&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke patients who have difficulty in walking independently regardless of assistive&#xD;
             devices due to problems such as visual field defects or fractures&#xD;
&#xD;
          -  Stroke patients with walking difficulty due to serious cognitive problems&#xD;
&#xD;
          -  Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not&#xD;
             suitable for wearing ankle assist robot&#xD;
&#xD;
          -  Stroke patients at risk of falling when walking with severe dizziness&#xD;
&#xD;
          -  Modified ashworth scale (MAS) Stroke patients over 3&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  People with mental illness and psychiatric medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YunHee Kim, Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2019</last_update_submitted>
  <last_update_submitted_qc>December 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gait function</keyword>
  <keyword>Metabolic energy expenditure</keyword>
  <keyword>ankle assist robot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</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/NCT03767205
org study id: 2018-06-128
nct id: NCT03767205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to identify the assistance effect of Ankle Assist Robot v1
      developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea)
      by comparing

        1. gait function during overground gait in three conditions (with robot-assist torque
           on/with robot-assist torque off/without robot)

        2. the energy expenditure during treadmill gait in three conditions (with robot-assist
           torque on/with robot-assist torque off/without robot)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change on gait speed in different three conditions
time frame: 20minutes
description: All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.
measure: Change on gait function in different three conditions (kinematic)
time frame: 20minutes
description: All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis.
measure: Change on gait function in different three conditions (kinetic)
time frame: 20minutes
description: All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate.
measure: Change on gait function in different three conditions (muscle activation)
time frame: 20minutes
description: All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG.
measure: Change on metabolic energy expenditure in different three conditions
time frame: 1 hour
description: All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
arm group label: stroke patients
arm group type: Experimental
description: All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).
intervention type: Device
intervention name: Ankle Assist Robot
description: overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate
treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
arm group label: stroke patients
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: YunHee Kim, Kim
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Gait Disorders, Neurologic