<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/NCT04497545</url>
  </required_header>
  <id_info>
    <org_study_id>Limanowa Trial</org_study_id>
    <nct_id>NCT04497545</nct_id>
  </id_info>
  <brief_title>The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients</brief_title>
  <official_title>The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EGZOTech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EGZOTech</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>
      Rehabilitation of lower limbs after a stroke supported by robots aims to return to&#xD;
      independence and minimize disability caused by the incident, but the results have been mixed.&#xD;
      Objective of the study was to assess the changes in gait capabilities, muscle tone and daily&#xD;
      activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation&#xD;
      process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants&#xD;
      with impaired motor function and gait after subacute stroke were included in the study. Each&#xD;
      patient was randomly assigned to an intervention (robot) or control group (RG or CG). All&#xD;
      patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for&#xD;
      6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG&#xD;
      received exercises on the lower limb rotor. Patients were evaluated before the start of the&#xD;
      study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead&#xD;
      mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle&#xD;
      circumference on the thigh.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2019</start_date>
  <completion_date type="Actual">January 13, 2020</completion_date>
  <primary_completion_date type="Actual">January 13, 2020</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 in Timed up and go test results</measure>
    <time_frame>baseline, after 4 weeks, after 6 weeks</time_frame>
    <description>the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Ashworth Scale results</measure>
    <time_frame>baseline, after 4 weeks, after 6 weeks</time_frame>
    <description>Measurement of resistance during passive knee flexion and extension&#xD;
Scorse range from 0 to 4, with 5 choices:&#xD;
Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal.&#xD;
resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved.&#xD;
Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Rivermeade Motor Assessment (RMA)</measure>
    <time_frame>baseline, after 4 weeks, after 6 weeks</time_frame>
    <description>The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers.&#xD;
Each item is scored either yes &quot;1&quot; or no &quot;0&quot;. It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in REPTY questionnair results</measure>
    <time_frame>baseline, after 4 weeks, after 6 weeks</time_frame>
    <description>a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tight Circumference</measure>
    <time_frame>baseline, after 4 weeks, after 6 weeks</time_frame>
    <description>thigh circumferences (5 and 15 centimeters above the patella),</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Luna EMG</intervention_name>
    <description>The duration of the overall therapeutic intervention in both groups will be the same.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lower limb rotor</intervention_name>
    <description>The duration of the overall therapeutic intervention in both groups will be the same.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ischemic stroke,&#xD;
&#xD;
          -  not later than 6 months ago,&#xD;
&#xD;
          -  muscle strength of extensors and knee flexors on the Lovetta scale below 3,&#xD;
&#xD;
          -  functional disorders of the lower limb,&#xD;
&#xD;
          -  patient's condition allowing full understanding of commands&#xD;
&#xD;
          -  continued/uninterrupted rehabilitation process for 28 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment-lack of or poor cooperation between the patient and the&#xD;
             therapist,&#xD;
&#xD;
          -  stroke (more than 6 months after the incident),&#xD;
&#xD;
          -  unstable clinical condition,&#xD;
&#xD;
          -  muscle strength of knee extensors and flexors on the Lovett scale greater than or&#xD;
             equal to 3,&#xD;
&#xD;
          -  rigid fixed contractures within the lower limb,&#xD;
&#xD;
          -  significant spasticity (Ashworth scale of 3 and above)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Years</minimum_age>
    <maximum_age>91 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rehstab</name>
      <address>
        <city>Limanowa</city>
        <state>Malopolskie Voivodship</state>
        <zip>34-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke,</keyword>
  <keyword>rehabilitation,</keyword>
  <keyword>EMG-triggered rehabilitation,</keyword>
  <keyword>robotic-assisted movement,</keyword>
  <keyword>gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04497545
org study id: Limanowa Trial
nct id: NCT04497545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rehabilitation of lower limbs after a stroke supported by robots aims to return to
      independence and minimize disability caused by the incident, but the results have been mixed.
      Objective of the study was to assess the changes in gait capabilities, muscle tone and daily
      activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation
      process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants
      with impaired motor function and gait after subacute stroke were included in the study. Each
      patient was randomly assigned to an intervention (robot) or control group (RG or CG). All
      patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for
      6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG
      received exercises on the lower limb rotor. Patients were evaluated before the start of the
      study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead
      mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle
      circumference on the thigh.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Timed up and go test results
time frame: baseline, after 4 weeks, after 6 weeks
description: the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair
measure: Change in Ashworth Scale results
time frame: baseline, after 4 weeks, after 6 weeks
description: Measurement of resistance during passive knee flexion and extension
Scorse range from 0 to 4, with 5 choices:
Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal.
resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved.
Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.
measure: Change in Rivermeade Motor Assessment (RMA)
time frame: baseline, after 4 weeks, after 6 weeks
description: The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers.
Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.
measure: change in REPTY questionnair results
time frame: baseline, after 4 weeks, after 6 weeks
description: a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)
measure: Change in Tight Circumference
time frame: baseline, after 4 weeks, after 6 weeks
description: thigh circumferences (5 and 15 centimeters above the patella),
arm group label: Study Group
arm group type: Experimental
description: A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device.
arm group label: Control Group
arm group type: Other
description: A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor
intervention type: Device
intervention name: Luna EMG
description: The duration of the overall therapeutic intervention in both groups will be the same.
arm group label: Study Group
intervention type: Device
intervention name: lower limb rotor
description: The duration of the overall therapeutic intervention in both groups will be the same.
arm group label: Control Group
criteria: 
gender: All
minimum age: 29 Years
maximum age: 91 Years
healthy volunteers: No
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: Undecided