<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/NCT03302871</url>
  </required_header>
  <id_info>
    <org_study_id>KOUKAEK 2016/20</org_study_id>
    <nct_id>NCT03302871</nct_id>
  </id_info>
  <brief_title>Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A</brief_title>
  <official_title>Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb&#xD;
      spasticity management in children with cerebral palsy (CP). Constraint Induced Movement&#xD;
      Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and&#xD;
      complimentary treatments to improve motor function in these children. In a recent trial&#xD;
      combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.&#xD;
&#xD;
      In this clinical trial the aim was to evaluate the effects of transcranial direct current&#xD;
      stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when&#xD;
      integrated with BoNT-A treatment in children with unilateral CP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although BoNT-A is effective in spasticity management there is inconclusive evidence to&#xD;
      support its usage for improvement in upper limb activity and function. Combination of BoNT-A&#xD;
      and occupational therapy (OT) is found to be more effective then OT alone in reducing&#xD;
      impairment, improving activity level and goal achievement. Intensive hybrid training models&#xD;
      of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning&#xD;
      in children with CP. The aim of this clinical trial is to show the additional gains that&#xD;
      could be provided by an integrated treatment of transcranial direct current stimulation&#xD;
      (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in&#xD;
      children with unilateral CP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2016</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <phase>Phase 3</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assisting Hand Assesment</measure>
    <time_frame>6 weeks</time_frame>
    <description>Bilateral Hand Function Evaluation Instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jebsen Taylor Hand Function Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Unilateral Hand Function Evaluation Instrument</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Modifed Ashworth Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measurement of Tone</description>
  </other_outcome>
  <other_outcome>
    <measure>Active ROM of wrist dorsiflexion</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measurement of active muscle function</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Tardieu Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measurement of spasticity</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>İntensive Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children who received Botulinum toxin type A to plegic upper limb would continue their usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>İntensive Therapy Group</arm_group_label>
    <other_name>Botox, Dysport</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <arm_group_label>İntensive Therapy Group</arm_group_label>
    <other_name>noninvasiv brain stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hybrid training model of CIMT and BIT</intervention_name>
    <arm_group_label>İntensive Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of unilateral cerebral palsy&#xD;
&#xD;
          -  able to activate wrist and finger extensors&#xD;
&#xD;
          -  being scheduled for BoNT-A treatment for upper limb&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant loss of wrist and or fingers&#xD;
&#xD;
          -  history of orthopedic surgery to plegic upper limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nigar Dursun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University</name>
      <address>
        <city>Kocaeli</city>
        <zip>41050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Nigar Dursun</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>botulinum toxin A</keyword>
  <keyword>constraint induced movement therapy</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT03302871
org study id: KOUKAEK 2016/20
nct id: NCT03302871
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb
      spasticity management in children with cerebral palsy (CP). Constraint Induced Movement
      Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and
      complimentary treatments to improve motor function in these children. In a recent trial
      combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.

      In this clinical trial the aim was to evaluate the effects of transcranial direct current
      stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when
      integrated with BoNT-A treatment in children with unilateral CP.
Although BoNT-A is effective in spasticity management there is inconclusive evidence to
      support its usage for improvement in upper limb activity and function. Combination of BoNT-A
      and occupational therapy (OT) is found to be more effective then OT alone in reducing
      impairment, improving activity level and goal achievement. Intensive hybrid training models
      of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning
      in children with CP. The aim of this clinical trial is to show the additional gains that
      could be provided by an integrated treatment of transcranial direct current stimulation
      (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in
      children with unilateral CP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Assisting Hand Assesment
time frame: 6 weeks
description: Bilateral Hand Function Evaluation Instrument
measure: Jebsen Taylor Hand Function Test
time frame: 6 weeks
description: Unilateral Hand Function Evaluation Instrument
measure: Modifed Ashworth Scale
time frame: 6 weeks
description: Measurement of Tone
measure: Active ROM of wrist dorsiflexion
time frame: 6 weeks
description: Measurement of active muscle function
measure: Modified Tardieu Scale
time frame: 6 weeks
description: Measurement of spasticity
arm group label: İntensive Therapy Group
arm group type: Experimental
description: Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT
arm group label: Control Group
arm group type: Active Comparator
description: Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
intervention type: Drug
intervention name: Botulinum toxin type A
arm group label: Control Group
arm group label: İntensive Therapy Group
other name: Botox, Dysport
intervention type: Device
intervention name: transcranial direct current stimulation
arm group label: İntensive Therapy Group
other name: noninvasiv brain stimulation
intervention type: Other
intervention name: hybrid training model of CIMT and BIT
arm group label: İntensive Therapy Group
intervention type: Other
intervention name: usual care
arm group label: Control Group
other name: physical therapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Nigar Dursun, MD
role: Principal Investigator
affiliation: Kocaeli University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Nigar Dursun
investigator title: Professor, MD
mesh term: Paralysis
mesh term: Cerebral Palsy
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No