xml: <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/NCT05985889</url>
    </required_header>
    <id_info>
      <org_study_id>IKEB/2023/01</org_study_id>
      <nct_id>NCT05985889</nct_id>
    </id_info>
    <brief_title>Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients</brief_title>
    <official_title>Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Somogy Megyei Kaposi Mór Teaching Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Somogy Megyei Kaposi Mór Teaching Hospital</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>
        We perform a comparison of several groups. We would like to determine how robotic and virtual&#xD;
        therapy is most effective in the treatment of stroke patients. We place great emphasis on&#xD;
        walking speed, quality of life, coordination and changes in walking distance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 8, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>mRS score</measure>
      <time_frame>3 weeks (0-5 score, high score better)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Barthel index score</measure>
      <time_frame>3 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Berg balance score</measure>
      <time_frame>3 weeks (0-30, high score better)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6MWT</measure>
      <time_frame>3 weeks</time_frame>
      <description>meter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10m gait speed</measure>
      <time_frame>3 weeks</time_frame>
      <description>m/s</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Robotic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They performed training with a robot 15 times over 3 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fizio</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They receive physiotherapy treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EXE1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual reality treatment is performed once a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EXE2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual reality treatment is performed twice a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EXE+ROB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual and robotic treatments are performed once a day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Robot</intervention_name>
      <description>You have to walk with a robot mounted on your lower limb. To move, to change direction.</description>
      <arm_group_label>Robotic</arm_group_label>
      <other_name>ROB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fizio</intervention_name>
      <description>Patients do state-funded physical therapy.</description>
      <arm_group_label>Fizio</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EXE1</intervention_name>
      <description>Patients undergo intensive virtual reality therapy once a day.</description>
      <arm_group_label>EXE1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EXE2</intervention_name>
      <description>Patients undergo intensive virtual reality therapy twice a day.</description>
      <arm_group_label>EXE2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EXE+ROB</intervention_name>
      <description>The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.</description>
      <arm_group_label>EXE+ROB</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          post stroke 6MWT : 120&gt; minimum after stroke 3 days be a stroke patient first stroke&#xD;
          hemiplegia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          multiple strokes, inability to stand and walk, cognitive function disorder does not reach&#xD;
          50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism&#xD;
          drug problems Drug&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dr. Tollár József</name>
        <address>
          <city>Kaposvár</city>
          <state>Somogy</state>
          <zip>7400</zip>
          <country>Hungary</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/?term=soft+exosuit</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Somogy Megyei Kaposi Mór Teaching Hospital</investigator_affiliation>
      <investigator_full_name>Tollár József</investigator_full_name>
      <investigator_title>Head of Department</investigator_title>
    </responsible_party>
    <keyword>robotic</keyword>
    <keyword>stroke</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>virtual rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985889
  org study id: IKEB/2023/01
  nct id: NCT05985889
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  We perform a comparison of several groups. We would like to determine how robotic and virtual
        therapy is most effective in the treatment of stroke patients. We place great emphasis on
        walking speed, quality of life, coordination and changes in walking distance.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: mRS score
  time frame: 3 weeks (0-5 score, high score better)
  measure: Barthel index score
  time frame: 3 weeks
  measure: Berg balance score
  time frame: 3 weeks (0-30, high score better)
  measure: 6MWT
  time frame: 3 weeks
  description: meter
  measure: 10m gait speed
  time frame: 3 weeks
  description: m/s
  arm group label: Robotic
  arm group type: Experimental
  description: They performed training with a robot 15 times over 3 weeks.
  arm group label: Fizio
  arm group type: Experimental
  description: They receive physiotherapy treatment.
  arm group label: EXE1
  arm group type: Experimental
  description: Virtual reality treatment is performed once a day.
  arm group label: EXE2
  arm group type: Experimental
  description: Virtual reality treatment is performed twice a day.
  arm group label: EXE+ROB
  arm group type: Experimental
  description: Virtual and robotic treatments are performed once a day.
  intervention type: Other
  intervention name: Robot
  description: You have to walk with a robot mounted on your lower limb. To move, to change direction.
  arm group label: Robotic
  other name: ROB
  intervention type: Other
  intervention name: Fizio
  description: Patients do state-funded physical therapy.
  arm group label: Fizio
  intervention type: Other
  intervention name: EXE1
  description: Patients undergo intensive virtual reality therapy once a day.
  arm group label: EXE1
  intervention type: Other
  intervention name: EXE2
  description: Patients undergo intensive virtual reality therapy twice a day.
  arm group label: EXE2
  intervention type: Other
  intervention name: EXE+ROB
  description: The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.
  arm group label: EXE+ROB
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 90 Years
  healthy volunteers: No
  facility: 
  country: Hungary
  url: https://pubmed.ncbi.nlm.nih.gov/?term=soft+exosuit
  description: Related Info
  responsible party type: Principal Investigator
  investigator affiliation: Somogy Megyei Kaposi Mór Teaching Hospital
  investigator full name: Tollár József
  investigator title: Head of Department
  mesh term: Stroke
  sharing ipd: No