<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/NCT03008434</url>
  </required_header>
  <id_info>
    <org_study_id>15-5905H</org_study_id>
    <nct_id>NCT03008434</nct_id>
  </id_info>
  <brief_title>Traumatic Brain Injury and Yoga</brief_title>
  <official_title>Traumatic Brain Injury and Yoga</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This long-term goal of this project was to advance best practices in occupational therapy in&#xD;
      conjunction with yoga. To address the long-term goal, this research team developed a pilot&#xD;
      yoga intervention. The intervention was designed to focus on balance, balance confidence,&#xD;
      body responsiveness, pain, physical ability and quality of life. Assessments were then chosen&#xD;
      to address these areas pre and post yoga intervention. A manual and protocol were developed&#xD;
      for the intervention and then the intervention was implemented with a group of individuals&#xD;
      with chronic traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility&#xD;
      and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a&#xD;
      mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga&#xD;
      intervention and then just following the 8 week yoga intervention. The objectives of this&#xD;
      feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga&#xD;
      for the traumatic brain injury intervention and 2) assess change in balance, balance&#xD;
      confidence, body responsiveness, pain, physical ability, and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>14 items to assess balance 14 items to assess balance 14 items to assess balance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities Balance Confidence Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assess balance self-efficacy or confidence to maintain balance while performing different actions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Yoga Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga twice a week for 8 weeks focusing on balance and pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assigned Interventions</intervention_name>
    <description>Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.</description>
    <arm_group_label>Yoga Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic TBI (&gt;6 months)&#xD;
&#xD;
          -  greater than or equal to 18 years of age&#xD;
&#xD;
          -  no consistent practice of yoga in the last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
&#xD;
          -  less than 18 years of age&#xD;
&#xD;
          -  self-report of exercise restriction&#xD;
&#xD;
          -  consistent yoga practice within the last year&#xD;
&#xD;
          -  inability to attend sessions based on transportation restrictions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arlene Schmid, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado State University</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 29, 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>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado State University</investigator_affiliation>
    <investigator_full_name>Arlene Schmid</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>yoga</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03008434
org study id: 15-5905H
nct id: NCT03008434
lead sponsor: 
has dmc: No
This long-term goal of this project was to advance best practices in occupational therapy in
      conjunction with yoga. To address the long-term goal, this research team developed a pilot
      yoga intervention. The intervention was designed to focus on balance, balance confidence,
      body responsiveness, pain, physical ability and quality of life. Assessments were then chosen
      to address these areas pre and post yoga intervention. A manual and protocol were developed
      for the intervention and then the intervention was implemented with a group of individuals
      with chronic traumatic brain injury.
This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility
      and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a
      mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga
      intervention and then just following the 8 week yoga intervention. The objectives of this
      feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga
      for the traumatic brain injury intervention and 2) assess change in balance, balance
      confidence, body responsiveness, pain, physical ability, and quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Berg Balance Scale
time frame: 8 weeks
description: 14 items to assess balance 14 items to assess balance 14 items to assess balance
measure: Activities Balance Confidence Scale
time frame: 8 weeks
description: Assess balance self-efficacy or confidence to maintain balance while performing different actions.
arm group label: Yoga Group
arm group type: Experimental
description: Yoga twice a week for 8 weeks focusing on balance and pain.
intervention type: Other
intervention name: Assigned Interventions
description: Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.
arm group label: Yoga Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arlene Schmid, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Colorado State University
investigator full name: Arlene Schmid
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: No