<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/NCT03007251</url>
  </required_header>
  <id_info>
    <org_study_id>EYT_10</org_study_id>
    <nct_id>NCT03007251</nct_id>
  </id_info>
  <brief_title>Immediate Effects of Eurythmy Therapy on Psychophysiological Parameters</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCIM Institute Academic Research in Complementary and Integrative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ARCIM Institute Academic Research in Complementary and Integrative Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate different effects of Eurythmy Therapy on&#xD;
      psychological and physiological parameters of circulation and thermoregulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulse Wave Velocity</measure>
    <time_frame>10 minutes after the movement exercises</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Eurythmy Therapy</condition>
  <arm_group>
    <arm_group_label>Eurythmy Therapy Movement &quot;R&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EYT exercise &quot;R&quot;: Positioned between two steps and forearms parallel to the ground, the patient performs a rolling movement like wheels on a wagon. The movement is positioned below shoulder height and is initiated from the shoulder blade.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eurythmy Therapy Movement &quot;L&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EYT exercise &quot;L&quot;: In a circular and flowing movement the patient leads his hands upwards in front of his body and down again laterally. During elevation of the arms, the patient performs a small hop onto the toes and into knock knees. Lowering his arms, he releases the legs and straightens up again.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eurythmy Therapy Movement &quot;B&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EYT exercise &quot;B&quot;: The patient describes an embracing movement with both arms and the left leg while balancing on one foot. He then returns to the initial position and repeats the movement using the other leg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal movements during walking or standing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control exercise: Participants slowly walk across the room, their arms swinging in a natural way. This was designed to control for the most basic upright movement, shifting thermoregulation from resting conditions to exercise conditions, triggering non-thermal factors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eurythmy Therapy Movement &quot;R&quot;</intervention_name>
    <arm_group_label>Eurythmy Therapy Movement &quot;R&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eurythmy Therapy Movement &quot;L&quot;</intervention_name>
    <arm_group_label>Eurythmy Therapy Movement &quot;L&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eurythmy Therapy Movement &quot;B&quot;</intervention_name>
    <arm_group_label>Eurythmy Therapy Movement &quot;B&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal movements during walking or standing</intervention_name>
    <arm_group_label>Normal movements during walking or standing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults 18-55 Years old, signed informed consent available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known diseases of the cardiovascular system, allergic reactions to electrode&#xD;
             patches in the past, coffee, alcohol or smoking less than 3 hours prior to the study,&#xD;
             insufficient knowledge of the German language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>July 17, 2017</last_update_submitted>
  <last_update_submitted_qc>July 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ARCIM Institute Academic Research in Complementary and Integrative Medicine</investigator_affiliation>
    <investigator_full_name>Dr. Jan Vagedes</investigator_full_name>
    <investigator_title>Director and Head of the ARCIM Institute</investigator_title>
  </responsible_party>
  <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/NCT03007251
org study id: EYT_10
nct id: NCT03007251
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate different effects of Eurythmy Therapy on
      psychological and physiological parameters of circulation and thermoregulation
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pulse Wave Velocity
time frame: 10 minutes after the movement exercises
arm group label: Eurythmy Therapy Movement "R"
arm group type: Experimental
description: EYT exercise "R": Positioned between two steps and forearms parallel to the ground, the patient performs a rolling movement like wheels on a wagon. The movement is positioned below shoulder height and is initiated from the shoulder blade.
arm group label: Eurythmy Therapy Movement "L"
arm group type: Experimental
description: EYT exercise "L": In a circular and flowing movement the patient leads his hands upwards in front of his body and down again laterally. During elevation of the arms, the patient performs a small hop onto the toes and into knock knees. Lowering his arms, he releases the legs and straightens up again.
arm group label: Eurythmy Therapy Movement "B"
arm group type: Experimental
description: EYT exercise "B": The patient describes an embracing movement with both arms and the left leg while balancing on one foot. He then returns to the initial position and repeats the movement using the other leg.
arm group label: Normal movements during walking or standing
arm group type: Active Comparator
description: Control exercise: Participants slowly walk across the room, their arms swinging in a natural way. This was designed to control for the most basic upright movement, shifting thermoregulation from resting conditions to exercise conditions, triggering non-thermal factors.
intervention type: Other
intervention name: Eurythmy Therapy Movement "R"
arm group label: Eurythmy Therapy Movement "R"
intervention type: Other
intervention name: Eurythmy Therapy Movement "L"
arm group label: Eurythmy Therapy Movement "L"
intervention type: Other
intervention name: Eurythmy Therapy Movement "B"
arm group label: Eurythmy Therapy Movement "B"
intervention type: Other
intervention name: Normal movements during walking or standing
arm group label: Normal movements during walking or standing
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: ARCIM Institute Academic Research in Complementary and Integrative Medicine
investigator full name: Dr. Jan Vagedes
investigator title: Director and Head of the ARCIM Institute
sharing ipd: No