<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/NCT01732731</url>
  </required_header>
  <id_info>
    <org_study_id>09-97</org_study_id>
    <secondary_id>527109</secondary_id>
    <nct_id>NCT01732731</nct_id>
  </id_info>
  <brief_title>Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment</brief_title>
  <official_title>Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Pacific</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Pacific</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to examine if early exposure to intensive, short-term&#xD;
      locomotor treadmill training (LT) in young children with neuromotor impairment will help&#xD;
      develop walking skills earlier, decrease the amount of outside assistance needed (such as a&#xD;
      walker or crutches) as compared to children with neuromotor impairment who receive&#xD;
      traditional physical therapy intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gross Motor Function Measure Dimension D and E</measure>
    <time_frame>up to 4-months post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peabody Developmental Motor Scales-2</measure>
    <time_frame>pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>timed 10 meter walk test</measure>
    <time_frame>pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Evaluation of Disability Inventory</measure>
    <time_frame>pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>treadmill training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children will receive home-based treadmill training with supervision from a physical therapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no treadmill training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>children will not receive treadmill training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>treadmill training</intervention_name>
    <description>Home-based treadmill training will be administered to the children in the experimental group</description>
    <arm_group_label>treadmill training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of CP with GMFCS levels I and II&#xD;
&#xD;
          -  ages 9 to 36 months&#xD;
&#xD;
          -  the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting&#xD;
&#xD;
          -  the ability to take ten consecutive steps when held on hands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of a genetic syndrome&#xD;
&#xD;
          -  independent ambulation without an assistive device&#xD;
&#xD;
          -  previous or current use of treadmill intervention during physical therapy&#xD;
&#xD;
          -  a medical contraindication for standing or walking defined by the physician 5)&#xD;
             uncontrolled seizures&#xD;
&#xD;
          -  a history of orthopedic surgery&#xD;
&#xD;
          -  use of medication to control spasticity in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katrin Mattern-Baxter</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Pacific</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>November 23, 2012</last_update_submitted>
  <last_update_submitted_qc>November 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral palsy</keyword>
  <keyword>treadmill training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT01732731
org study id: 09-97
secondary id: 527109
nct id: NCT01732731
lead sponsor: 
has dmc: No
The purpose of this project is to examine if early exposure to intensive, short-term
      locomotor treadmill training (LT) in young children with neuromotor impairment will help
      develop walking skills earlier, decrease the amount of outside assistance needed (such as a
      walker or crutches) as compared to children with neuromotor impairment who receive
      traditional physical therapy intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Gross Motor Function Measure Dimension D and E
time frame: up to 4-months post-intervention
measure: Peabody Developmental Motor Scales-2
time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
measure: timed 10 meter walk test
time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
measure: Pediatric Evaluation of Disability Inventory
time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
arm group label: treadmill training
arm group type: Experimental
description: children will receive home-based treadmill training with supervision from a physical therapist
arm group label: no treadmill training
arm group type: No Intervention
description: children will not receive treadmill training
intervention type: Other
intervention name: treadmill training
description: Home-based treadmill training will be administered to the children in the experimental group
arm group label: treadmill training
criteria: 
gender: All
minimum age: 9 Months
maximum age: 36 Months
healthy volunteers: No
last name: Katrin Mattern-Baxter
role: Principal Investigator
affiliation: University of the Pacific
responsible party type: Sponsor
mesh term: Cerebral Palsy