<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/NCT02988557</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0089</org_study_id>
    <nct_id>NCT02988557</nct_id>
  </id_info>
  <brief_title>Walking Inclined Plane</brief_title>
  <official_title>Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and&#xD;
      dynamic electromyography recordings, will be studied in children with bilateral spastic&#xD;
      cerebral palsy during level walking, and before and after a training on a treadmill with a&#xD;
      sloped surface (7°). Data will be compared with those obtained in a sample of typically&#xD;
      developing (TD) children (controls)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      15 CP children and 15 TD children aged 6 to 14 years will take part in this study. Dynamic&#xD;
      EMG recordings will be performed as well as kinematic data assessments through a gait&#xD;
      analysis system. Three different slopes will be assessed, using a treadmill. The primary&#xD;
      outcome measure will be the minimal knee extension value in the stance phase. The changes in&#xD;
      kinematics will be overall assessed through the Gait Profile Score (Baker et al.). The&#xD;
      details in changes will be assessed through statistical parametric mapping (SPM). The changes&#xD;
      in muscle activity induced by the slope will be investigated by statistical parametric&#xD;
      mapping of the EMG or kinematic data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</primary_completion_date>
  <phase>N/A</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>minimal knee extension in stance (kinematics)</measure>
    <time_frame>1 day (single evaluation)</time_frame>
    <description>quantitative value of the extension (degree(s))</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Spastic Diplegia</condition>
  <arm_group>
    <arm_group_label>Treadmill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>walking on a treadmill with a sloped surface</intervention_name>
    <description>walking on a treadmill with a sloped surface</description>
    <arm_group_label>Treadmill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>treadmill</intervention_name>
    <description>walking on a treadmill with a sloped surface</description>
    <arm_group_label>Treadmill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for children with CP:&#xD;
&#xD;
          -  age = 6-14 years old&#xD;
&#xD;
          -  children with cerebral palsy: spastic type, bilateral involvement, forefoot initial&#xD;
             contact and/or excessive knee flexion at mid-stance and/or decreased hip extension in&#xD;
             late stance.&#xD;
&#xD;
          -  GMFCS I or II,&#xD;
&#xD;
          -  Score on Gillette scale between 8 and 10&#xD;
&#xD;
          -  able to walk at least 10 min without help&#xD;
&#xD;
        Inclusion Criteria for TD children:&#xD;
&#xD;
          -  age = 6-14 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  botulinum toxin injection or lower limb surgery within the last year.&#xD;
&#xD;
          -  Uncontrolled seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>gait</keyword>
  <keyword>slope</keyword>
  <keyword>electromyography</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/NCT02988557
org study id: RC16_0089
nct id: NCT02988557
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and
      dynamic electromyography recordings, will be studied in children with bilateral spastic
      cerebral palsy during level walking, and before and after a training on a treadmill with a
      sloped surface (7°). Data will be compared with those obtained in a sample of typically
      developing (TD) children (controls)
15 CP children and 15 TD children aged 6 to 14 years will take part in this study. Dynamic
      EMG recordings will be performed as well as kinematic data assessments through a gait
      analysis system. Three different slopes will be assessed, using a treadmill. The primary
      outcome measure will be the minimal knee extension value in the stance phase. The changes in
      kinematics will be overall assessed through the Gait Profile Score (Baker et al.). The
      details in changes will be assessed through statistical parametric mapping (SPM). The changes
      in muscle activity induced by the slope will be investigated by statistical parametric
      mapping of the EMG or kinematic data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: minimal knee extension in stance (kinematics)
time frame: 1 day (single evaluation)
description: quantitative value of the extension (degree(s))
arm group label: Treadmill
arm group type: Experimental
intervention type: Procedure
intervention name: walking on a treadmill with a sloped surface
description: walking on a treadmill with a sloped surface
arm group label: Treadmill
intervention type: Device
intervention name: treadmill
description: walking on a treadmill with a sloped surface
arm group label: Treadmill
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Palsy