<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/NCT03035968</url>
  </required_header>
  <id_info>
    <org_study_id>Höchster Vojta Stroke Studie</org_study_id>
    <nct_id>NCT03035968</nct_id>
  </id_info>
  <brief_title>Vojta Therapy in Early Stroke Rehabilitation</brief_title>
  <official_title>Improvement of Postural Control and Motor Function by Vojta Therapy in Early Stroke Rehabilitation of Stroke Patients - a Pilot Study and New Approach in Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corina Epple</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinikum Frankfurt Höchst</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>
      Stroke is the major cause for permanent disability in adults. It is still unclear, which&#xD;
      physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely&#xD;
      used approaches in stroke rehabilitation within the western world, although several studies&#xD;
      have failed to demonstrate superiority and showed partially even inferiority compared to&#xD;
      other physiotherapy approaches. The Vojta therapy is based on a completely different approach&#xD;
      - the reflex locomotion. However to date no study has been performed for stroke. We designed&#xD;
      a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients&#xD;
      with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to&#xD;
      investigate improvement of postural control due to Vojta therapy in early rehabilitation of&#xD;
      stroke patients, which is a very new approach in stroke-rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2015</start_date>
  <completion_date type="Actual">July 4, 2017</completion_date>
  <primary_completion_date type="Actual">April 14, 2017</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>Single (Outcomes Assessor)</masking>
    <masking_description>The assessor for the secondary outcome (Barthel Index and mRS after 90 days) is blinded. All other outcome assessors have knowledge of the interventions assigned to individual participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital</measure>
    <time_frame>Day 1-9 after admission to hospital (+/- 1)</time_frame>
    <description>The Trunc Control Test (TCT) is a valid test to asses motor impairment after stroke. A range of 0 to 100 points can be achieved. Patients are tested before the first treatment on day 2, after 5 days and after the last intervention on day 9 (+/-1) after admission to hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of neglect measured with the Catherine Bergego Scale (part 5 and 6) after on day 9 after admission to the hospital (compared to baseline)</measure>
    <time_frame>Day 1-9 after hospital admission (+/- 1)</time_frame>
    <description>The neglect is assessed with part 5 and 6 of the Catherine Bergego Scale. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of arm motor function measured with the motor evaluation scale for upper extremity in stroke patients [MESUPES, part 1 to 4] on day 9 after admission to the hospital (compared to baseline)</measure>
    <time_frame>Day 1-9 after hospital admission (+/- 1)</time_frame>
    <description>The arm motor function is assessed with part 1 to 4 of the MESUPES. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the Barthel Index on day 9 after admission to the hospital</measure>
    <time_frame>Day 1-9 after hospital admission (+/- 1)</time_frame>
    <description>The Barthel Index is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the NIHSS on day 9 after admission to the hospital</measure>
    <time_frame>Day 1-9 after hospital admission (+/- 1)</time_frame>
    <description>The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.</measure>
    <time_frame>Day 1-9.</time_frame>
    <description>Patients are assessed for the neglect 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of the neglect directly after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.</measure>
    <time_frame>Day 1-9.</time_frame>
    <description>Patients are assessed for the motor function 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of motor function directly after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset</measure>
    <time_frame>Day 90 after stroke onset</time_frame>
    <description>The mRS is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day mRS is assessed via telephone interview by a blinded assessor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the Barthel Index on day 90 after stroke onset</measure>
    <time_frame>Day 90 after stroke onset</time_frame>
    <description>The Barthel Index is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day Barthel Index is assessed via telephone interview by a blinded assessor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Vojta Therapy</condition>
  <condition>Reflex Locomotion</condition>
  <arm_group>
    <arm_group_label>Vojta arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional physiotherapy arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vojta therapy</intervention_name>
    <arm_group_label>Vojta arm</arm_group_label>
    <other_name>reflex locomotion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional physiotherapy</intervention_name>
    <arm_group_label>conventional physiotherapy arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt; 18 years)&#xD;
&#xD;
          -  CT or MRI proven acute ischemic (AIS) or hemorrhagic stroke (ICH) within 72h after&#xD;
             onset of symptoms&#xD;
&#xD;
          -  Severe hemiparesis (medical research council scale for muscle strength ≤2)&#xD;
&#xD;
          -  premorbid modified Rankin Scale (mRS) ≤3&#xD;
&#xD;
          -  maximal National Institute of Health Stroke Scale Score (NIHSS) 25&#xD;
&#xD;
          -  Voluntary written consent by the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment due to aphasia or dementia, prohibiting that&#xD;
             physiotherapeutic challenges can be understood.&#xD;
&#xD;
          -  Participation on another clinical trial&#xD;
&#xD;
          -  Pregnancy&#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>Klinikum Frankfurt Höchst</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60311</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.vojta.com</url>
    <description>Homepage of the International Vojta Society</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Klinikum Frankfurt Höchst</investigator_affiliation>
    <investigator_full_name>Corina Epple</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Vojta therapy</keyword>
  <keyword>reflex locomotion</keyword>
  <keyword>stroke rehabilitation</keyword>
  <keyword>stroke</keyword>
  <keyword>physiotherapy</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>


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/NCT03035968
org study id: Höchster Vojta Stroke Studie
nct id: NCT03035968
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is the major cause for permanent disability in adults. It is still unclear, which
      physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely
      used approaches in stroke rehabilitation within the western world, although several studies
      have failed to demonstrate superiority and showed partially even inferiority compared to
      other physiotherapy approaches. The Vojta therapy is based on a completely different approach
      - the reflex locomotion. However to date no study has been performed for stroke. We designed
      a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients
      with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to
      investigate improvement of postural control due to Vojta therapy in early rehabilitation of
      stroke patients, which is a very new approach in stroke-rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessor for the secondary outcome (Barthel Index and mRS after 90 days) is blinded. All other outcome assessors have knowledge of the interventions assigned to individual participants.
measure: Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
time frame: Day 1-9 after admission to hospital (+/- 1)
description: The Trunc Control Test (TCT) is a valid test to asses motor impairment after stroke. A range of 0 to 100 points can be achieved. Patients are tested before the first treatment on day 2, after 5 days and after the last intervention on day 9 (+/-1) after admission to hospital.
measure: Improvement of neglect measured with the Catherine Bergego Scale (part 5 and 6) after on day 9 after admission to the hospital (compared to baseline)
time frame: Day 1-9 after hospital admission (+/- 1)
description: The neglect is assessed with part 5 and 6 of the Catherine Bergego Scale. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.
measure: Improvement of arm motor function measured with the motor evaluation scale for upper extremity in stroke patients [MESUPES, part 1 to 4] on day 9 after admission to the hospital (compared to baseline)
time frame: Day 1-9 after hospital admission (+/- 1)
description: The arm motor function is assessed with part 1 to 4 of the MESUPES. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.
measure: Improvement of the Barthel Index on day 9 after admission to the hospital
time frame: Day 1-9 after hospital admission (+/- 1)
description: The Barthel Index is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.
measure: Improvement of the NIHSS on day 9 after admission to the hospital
time frame: Day 1-9 after hospital admission (+/- 1)
description: The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.
measure: Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.
time frame: Day 1-9.
description: Patients are assessed for the neglect 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of the neglect directly after treatment.
measure: Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.
time frame: Day 1-9.
description: Patients are assessed for the motor function 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of motor function directly after treatment.
measure: Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset
time frame: Day 90 after stroke onset
description: The mRS is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day mRS is assessed via telephone interview by a blinded assessor
measure: Improvement of the Barthel Index on day 90 after stroke onset
time frame: Day 90 after stroke onset
description: The Barthel Index is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day Barthel Index is assessed via telephone interview by a blinded assessor
arm group label: Vojta arm
arm group type: Experimental
description: Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
arm group label: conventional physiotherapy arm
arm group type: Active Comparator
description: Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.
intervention type: Other
intervention name: Vojta therapy
arm group label: Vojta arm
other name: reflex locomotion
intervention type: Other
intervention name: conventional physiotherapy
arm group label: conventional physiotherapy arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
url: http://www.vojta.com
description: Homepage of the International Vojta Society
responsible party type: Sponsor-Investigator
investigator affiliation: Klinikum Frankfurt Höchst
investigator full name: Corina Epple
investigator title: Principle Investigator
mesh term: Stroke
sharing ipd: No