<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/NCT03818152</url>
  </required_header>
  <id_info>
    <org_study_id>B670201834766/Amendement</org_study_id>
    <nct_id>NCT03818152</nct_id>
  </id_info>
  <brief_title>Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.</brief_title>
  <official_title>Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence&#xD;
      on muscle strength and consequently on functional behavior and participation. Evidence of&#xD;
      strength training programs has been shown on level of body function but transfer to levels of&#xD;
      activity and participation is still limited. Lack of transfer is related to lack of&#xD;
      specificity of the training and poor overall quality of the interventions (intensity,&#xD;
      duration, frequency and/or type).&#xD;
&#xD;
      The use of functional strength exercises to assess and train strength of the lower limbs in&#xD;
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).&#xD;
      To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings&#xD;
      but reliability of this tool is questionable.&#xD;
&#xD;
      The aim of this study is to adapt existing functional strength tests for less functional&#xD;
      children with CP (focussing on GMFCS level II and III) and to investigate the correlation&#xD;
      with isometric strength measurements and other functional parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence&#xD;
      on muscle strength and consequently on functional behavior and participation. Evidence of&#xD;
      strength training programs has been shown on level of body function but transfer to levels of&#xD;
      activity and participation is still limited. Lack of transfer is related to lack of&#xD;
      specificity of the training and poor overall quality of the interventions (intensity,&#xD;
      duration, frequency and/or type).&#xD;
&#xD;
      The use of functional strength exercises to assess and train strength of the lower limbs in&#xD;
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).&#xD;
&#xD;
      The aim of this study is to adapt existing functional strength tests for less functional&#xD;
      children with CP (focussing on GMFCS-level II and III) and to investigate the correlation&#xD;
      with isometric strength measurements and other functional parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</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>Functional testing</measure>
    <time_frame>60 minutes</time_frame>
    <description>30 seconds tests (nr/30 seconds): the children have to perform as much as trials as possible within 30 seconds; e.g. stand up and sit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Isometric strength test</measure>
    <time_frame>60 minutes</time_frame>
    <description>Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core stability test</measure>
    <time_frame>30 minutes</time_frame>
    <description>30 seconds tests (nr/3 30 seconds test (nr/30 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait capacity</measure>
    <time_frame>1 minute</time_frame>
    <description>1 Minute Walking Test (m/1 minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait capacity</measure>
    <time_frame>5 minutes</time_frame>
    <description>Timed up and go (seconds)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Children</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Reliability study isokinetic strength assessment of the lower limbs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional strength assessment</intervention_name>
    <description>Functional strength exercises to assess strength in lower limbs.</description>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilateral spastic CP&#xD;
&#xD;
          -  GMFCS II-III&#xD;
&#xD;
          -  6-18 Y&#xD;
&#xD;
          -  No botox until 4 months before testing&#xD;
&#xD;
          -  No orthopedic surgery until 1 Y before testing&#xD;
&#xD;
          -  Good cooperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral palsy</keyword>
  <keyword>Children</keyword>
  <keyword>Functional strength measurement</keyword>
  <keyword>Lower limbs</keyword>
  <keyword>Reproducability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03818152
org study id: B670201834766/Amendement
nct id: NCT03818152
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence
      on muscle strength and consequently on functional behavior and participation. Evidence of
      strength training programs has been shown on level of body function but transfer to levels of
      activity and participation is still limited. Lack of transfer is related to lack of
      specificity of the training and poor overall quality of the interventions (intensity,
      duration, frequency and/or type).

      The use of functional strength exercises to assess and train strength of the lower limbs in
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).
      To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings
      but reliability of this tool is questionable.

      The aim of this study is to adapt existing functional strength tests for less functional
      children with CP (focussing on GMFCS level II and III) and to investigate the correlation
      with isometric strength measurements and other functional parameters.
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence
      on muscle strength and consequently on functional behavior and participation. Evidence of
      strength training programs has been shown on level of body function but transfer to levels of
      activity and participation is still limited. Lack of transfer is related to lack of
      specificity of the training and poor overall quality of the interventions (intensity,
      duration, frequency and/or type).

      The use of functional strength exercises to assess and train strength of the lower limbs in
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).

      The aim of this study is to adapt existing functional strength tests for less functional
      children with CP (focussing on GMFCS-level II and III) and to investigate the correlation
      with isometric strength measurements and other functional parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional testing
time frame: 60 minutes
description: 30 seconds tests (nr/30 seconds): the children have to perform as much as trials as possible within 30 seconds; e.g. stand up and sit
measure: Isometric strength test
time frame: 60 minutes
description: Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer
measure: Core stability test
time frame: 30 minutes
description: 30 seconds tests (nr/3 30 seconds test (nr/30 seconds)
measure: Gait capacity
time frame: 1 minute
description: 1 Minute Walking Test (m/1 minute)
measure: Gait capacity
time frame: 5 minutes
description: Timed up and go (seconds)
arm group label: study group
arm group type: Other
description: Reliability study isokinetic strength assessment of the lower limbs.
intervention type: Other
intervention name: Functional strength assessment
description: Functional strength exercises to assess strength in lower limbs.
arm group label: study group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: Undecided