<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/NCT02979743</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC0100300CP01</org_study_id>
    <nct_id>NCT02979743</nct_id>
  </id_info>
  <brief_title>MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy</brief_title>
  <official_title>MRI-based Neuroimaging Predictors of Clinical Improvements Following Occupational Therapy (OT) or OT Puls Acupuncture and Massage Methods in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenzhen Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baoji Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hainan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore the relationship between brain MRI-metrics and hand&#xD;
      function observed in children with cerebral palsy (CP),compared between baseline and the&#xD;
      third month, and thus determine the early MRI-based neuroimaging predictor of clinical&#xD;
      improvement following therapy in children with CP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy (CP) is the commonest cause of neurological disability in children. The upper&#xD;
      limbs are often affected, with significant hand involvement from an early age.There are&#xD;
      various methods of treatment for CP children with hand function disability. However, there is&#xD;
      a lack of effective methods to predict the prognosis.&#xD;
&#xD;
      This prospective cohort study will include children with occupational therapy (OT) or OT plus&#xD;
      acupuncture and massage methods. Children with CP will be evaluated in terms of upper limb&#xD;
      motor function using the manual ability classification system (MACS), fine motor function&#xD;
      measure (FMFM). The Brain injuries of Children will be evaluated by MRI.&#xD;
&#xD;
      The aim of this study is to explore the relationship between brain MRI-metrics and hand&#xD;
      function, compared between baseline and the third month, and thus determine the early&#xD;
      MRI-based neuroimaging predictors of clinical improvements following therapy in children with&#xD;
      CP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fine motor function measure (scores)</measure>
    <time_frame>Baseline</time_frame>
    <description>It is acquired at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fine motor function measure (scores)</measure>
    <time_frame>The 3rd month</time_frame>
    <description>It is acquired at 3 months later following therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gross motor function measure and classification system (scores)</measure>
    <time_frame>Baseline</time_frame>
    <description>It is acquired at baseline.The system is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross motor function measure and classification system (scores)</measure>
    <time_frame>The 3rd month</time_frame>
    <description>It is acquired at 3 months later following therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Brain Injury, Chronic</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Occupational therapy group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The children worked with an occupational therapist for 4 hours a day for 5 days per week (totaling 40 hours) and initially concentrated on unilateral activities with the hemiplegic hand,and added bilateral activities during the second week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Occupational therapy puls acupuncture and massage methods</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients receive occupational therapy puls acupuncture and massage methods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational therapy</intervention_name>
    <arm_group_label>Occupational therapy group</arm_group_label>
    <arm_group_label>Occupational therapy puls acupuncture and massage methods</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Occupational therapy puls acupuncture and massage methods</intervention_name>
    <arm_group_label>Occupational therapy puls acupuncture and massage methods</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 3-18 years&#xD;
&#xD;
          -  Spastic cerebral palsy&#xD;
&#xD;
          -  The complete clinical and MRI data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous acupuncture and massage methods&#xD;
&#xD;
          -  botulinum toxin upper limb injections&#xD;
&#xD;
          -  braces artifact, excessive motion, afraid to enter the MRI&#xD;
&#xD;
          -  parents were not interested in the MRI sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jian Yang, Ph.D.,M.D.</last_name>
    <phone>+8618991232396</phone>
    <email>cjr.yangjian@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Yang, Ph.D.,M.D.</last_name>
      <phone>+8618991232396</phone>
      <email>cjr.yangjian@vip.163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Brain Injury, Chronic</mesh_term>
  </condition_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/NCT02979743
org study id: 2016YFC0100300CP01
nct id: NCT02979743
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to explore the relationship between brain MRI-metrics and hand
      function observed in children with cerebral palsy (CP),compared between baseline and the
      third month, and thus determine the early MRI-based neuroimaging predictor of clinical
      improvement following therapy in children with CP.
Cerebral palsy (CP) is the commonest cause of neurological disability in children. The upper
      limbs are often affected, with significant hand involvement from an early age.There are
      various methods of treatment for CP children with hand function disability. However, there is
      a lack of effective methods to predict the prognosis.

      This prospective cohort study will include children with occupational therapy (OT) or OT plus
      acupuncture and massage methods. Children with CP will be evaluated in terms of upper limb
      motor function using the manual ability classification system (MACS), fine motor function
      measure (FMFM). The Brain injuries of Children will be evaluated by MRI.

      The aim of this study is to explore the relationship between brain MRI-metrics and hand
      function, compared between baseline and the third month, and thus determine the early
      MRI-based neuroimaging predictors of clinical improvements following therapy in children with
      CP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Fine motor function measure (scores)
time frame: Baseline
description: It is acquired at baseline.
measure: Fine motor function measure (scores)
time frame: The 3rd month
description: It is acquired at 3 months later following therapy.
measure: Gross motor function measure and classification system (scores)
time frame: Baseline
description: It is acquired at baseline.The system is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
measure: Gross motor function measure and classification system (scores)
time frame: The 3rd month
description: It is acquired at 3 months later following therapy.
arm group label: Occupational therapy group
arm group type: Placebo Comparator
description: The children worked with an occupational therapist for 4 hours a day for 5 days per week (totaling 40 hours) and initially concentrated on unilateral activities with the hemiplegic hand,and added bilateral activities during the second week.
arm group label: Occupational therapy puls acupuncture and massage methods
arm group type: Active Comparator
description: The patients receive occupational therapy puls acupuncture and massage methods.
intervention type: Behavioral
intervention name: Occupational therapy
arm group label: Occupational therapy group
arm group label: Occupational therapy puls acupuncture and massage methods
intervention type: Other
intervention name: Occupational therapy puls acupuncture and massage methods
arm group label: Occupational therapy puls acupuncture and massage methods
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jian Yang, Ph.D.,M.D.
phone: +8618991232396
email: cjr.yangjian@vip.163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Cerebral Palsy
mesh term: Brain Injury, Chronic
sharing ipd: No