<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/NCT03307161</url>
  </required_header>
  <id_info>
    <org_study_id>1130</org_study_id>
    <nct_id>NCT03307161</nct_id>
  </id_info>
  <brief_title>Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia</brief_title>
  <official_title>Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine if posture and heart rate variability will significantly improve in&#xD;
      Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine if posture and heart rate variability will significantly improve in&#xD;
      Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic&#xD;
      manual treatments for truncal flexion dystonia as measured by the distance of the external&#xD;
      acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate&#xD;
      variability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in posture</measure>
    <time_frame>8 weeks</time_frame>
    <description>inches of forward head carriage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in heart rate variability</measure>
    <time_frame>8 weeks</time_frame>
    <description>heart rate changes</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Dystonia</condition>
  <condition>Autonomic Dysreflexia</condition>
  <arm_group>
    <arm_group_label>Parkinsons fwd posture manual treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject will receive the intervention, osteopathic manual treatment protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinsons forward posture</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinsons without forward posture</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>osteopathic manual therapy</intervention_name>
    <description>Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms</description>
    <arm_group_label>Parkinsons fwd posture manual treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease; able to stand for three minutes or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe dementia, moderate or severe hallucinations and psychosis; unable to stand for&#xD;
             three minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayme Mancini, PhD DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYIT col osteopathic medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Institute of Technology</name>
      <address>
        <city>Old Westbury</city>
        <state>New York</state>
        <zip>11568</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>manual therapy</keyword>
  <keyword>heart rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Autonomic Dysreflexia</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/NCT03307161
org study id: 1130
nct id: NCT03307161
lead sponsor: 
has dmc: No
This study will determine if posture and heart rate variability will significantly improve in
      Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.
This study will determine if posture and heart rate variability will significantly improve in
      Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic
      manual treatments for truncal flexion dystonia as measured by the distance of the external
      acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate
      variability.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in posture
time frame: 8 weeks
description: inches of forward head carriage
measure: change in heart rate variability
time frame: 8 weeks
description: heart rate changes
arm group label: Parkinsons fwd posture manual treatment
arm group type: Active Comparator
description: Subject will receive the intervention, osteopathic manual treatment protocol.
arm group label: Parkinsons forward posture
arm group type: No Intervention
description: Subjects will receive counseling.
arm group label: Parkinsons without forward posture
arm group type: No Intervention
description: Subjects will receive counseling.
intervention type: Other
intervention name: osteopathic manual therapy
description: Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms
arm group label: Parkinsons fwd posture manual treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jayme Mancini, PhD DO
role: Principal Investigator
affiliation: NYIT col osteopathic medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Autonomic Dysreflexia
sharing ipd: No