<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/NCT01700777</url>
  </required_header>
  <id_info>
    <org_study_id>UHMG-IONS-862010</org_study_id>
    <nct_id>NCT01700777</nct_id>
  </id_info>
  <brief_title>Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT &amp; Leg)</brief_title>
  <official_title>Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives (Infirmes Moteurs cérébraux).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Mont-Godinne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of Mont-Godinne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized control trial of &quot;HABIT-ILE&quot; therapy compared with regular / conventional&#xD;
      intervention (same amount of hours). The protocols have been developed on the basis of&#xD;
      bimanual therapy (HABIT) developed at Columbia University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized control trial of &quot;HABIT-ILE&quot; therapy at intensive frequency contrasted with&#xD;
      regular frequency intervention. The protocols have been developed on the basis of bimanual&#xD;
      therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2&#xD;
      weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week).&#xD;
      Children of all groups will benefit from 90h of intensive treatment (children in regular&#xD;
      frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the&#xD;
      regular interventions, there is at least one therapist for each child.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2010</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impairment, disability, participation</measure>
    <time_frame>4 years</time_frame>
    <description>The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Congenital Hemiplegia</condition>
  <arm_group>
    <arm_group_label>Intensive rehab group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of children will beneficiate of &quot;HABIT-ILE&quot; treatment in an intensive way (camp) for 90h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;HABIT-ILE&quot;</intervention_name>
    <description>90 h of training with &quot;HABIT-ILE&quot;, in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).</description>
    <arm_group_label>Intensive rehab group</arm_group_label>
    <arm_group_label>Regular treatment group</arm_group_label>
    <other_name>Bimanual training, HABIT, neurorehabilitation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willingness to enter the research program and the testing procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled epilepsy&#xD;
&#xD;
          -  upper limb injections in the upper limb during the last six months / or intend to&#xD;
             receive during the training period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yannick Bleyenheuft, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Neurosciences, UCL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corinne Bleyenheuft, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques Universitaires de Mont-Godinne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yannick Bleyenheuft, PhD</last_name>
    <phone>+32486919911</phone>
    <email>yannick.bleyenheuft@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Corinne Bleyenheuft, MD resp.</last_name>
    <email>corinne.bleyenheuft@uclouvain.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Neurosciences, UCL</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yannick Bleyenheuft, PhD</last_name>
      <phone>+32486919911</phone>
      <email>yannick.bleyenheuft@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Yannick Bleyenheuft, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>January 21, 2014</last_update_submitted>
  <last_update_submitted_qc>January 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Mont-Godinne</investigator_affiliation>
    <investigator_full_name>Yannick Bleyenheuft</investigator_full_name>
    <investigator_title>Scientific collaborator, Institute of Neuroscience UCL</investigator_title>
  </responsible_party>
  <keyword>bimanual training</keyword>
  <keyword>lower limb</keyword>
  <keyword>intensive rehabilitation</keyword>
  <keyword>regular rehabilitation</keyword>
  <keyword>hemiplegia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</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/NCT01700777
org study id: UHMG-IONS-862010
nct id: NCT01700777
lead sponsor: 
collaborator: 
has dmc: Yes
A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional
      intervention (same amount of hours). The protocols have been developed on the basis of
      bimanual therapy (HABIT) developed at Columbia University.
A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with
      regular frequency intervention. The protocols have been developed on the basis of bimanual
      therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2
      weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week).
      Children of all groups will benefit from 90h of intensive treatment (children in regular
      frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the
      regular interventions, there is at least one therapist for each child.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Impairment, disability, participation
time frame: 4 years
description: The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.
arm group label: Intensive rehab group
arm group type: Experimental
description: A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.
arm group label: Regular treatment group
arm group type: Active Comparator
description: A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.
intervention type: Other
intervention name: "HABIT-ILE"
description: 90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).
arm group label: Intensive rehab group
arm group label: Regular treatment group
other name: Bimanual training, HABIT, neurorehabilitation
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yannick Bleyenheuft, PhD
role: Principal Investigator
affiliation: Institute of Neurosciences, UCL
last name: Corinne Bleyenheuft, MD
role: Principal Investigator
affiliation: Cliniques Universitaires de Mont-Godinne
last name: Yannick Bleyenheuft, PhD
phone: +32486919911
email: yannick.bleyenheuft@gmail.com
last name: Corinne Bleyenheuft, MD resp.
email: corinne.bleyenheuft@uclouvain.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Mont-Godinne
investigator full name: Yannick Bleyenheuft
investigator title: Scientific collaborator, Institute of Neuroscience UCL
mesh term: Hemiplegia