<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/NCT03765034</url>
  </required_header>
  <id_info>
    <org_study_id>CCI-10-00255</org_study_id>
    <nct_id>NCT03765034</nct_id>
  </id_info>
  <brief_title>Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury</brief_title>
  <official_title>Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Los Angeles</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>
      This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care&#xD;
      occupational therapy in children with perinatal brachial plexus injury. Participants are&#xD;
      randomized to receive either the intervention (CIMT) or control first, then cross over to&#xD;
      receive the other one.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with perinatal brachial plexus injury routinely receive occupational therapy&#xD;
      intervention to improve strength and function in their weak or paralyzed arm.&#xD;
&#xD;
      Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in&#xD;
      children with weakness or disuse as a result of cerebral palsy. However, it is unknown if&#xD;
      this therapy is effective for treating arm weakness or disuse as a result of perinatal&#xD;
      brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care&#xD;
      is evaluated in this trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assisting Hand Assessment 5.0</measure>
    <time_frame>change from baseline at 8 weeks and 16 weeks</time_frame>
    <description>Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Neonatal Brachial Plexus Palsy</condition>
  <arm_group>
    <arm_group_label>Constraint-induced Movement Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Occupational Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual and standard care occupational therapy is administered for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Constrain-induced Movement Therapy</intervention_name>
    <description>8-week therapy program utilizing constraint of the unaffected arm</description>
    <arm_group_label>Constraint-induced Movement Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Occupational Therapy</intervention_name>
    <description>8-week therapy program without constraint of the unaffected arm</description>
    <arm_group_label>Constraint-induced Movement Therapy</arm_group_label>
    <arm_group_label>Usual Occupational Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has perinatal brachial plexus injury&#xD;
&#xD;
          -  Participant walking at time of study inception&#xD;
&#xD;
          -  Ability to cooperate with interventions and assessment&#xD;
&#xD;
          -  Participant currently receiving occupational therapy 1+ hour per week and planning to&#xD;
             continue for duration of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-morbid diagnosis not related to perinatal brachial plexus injury&#xD;
&#xD;
          -  Flaccidity of the involved upper extremity or no observable hand function&#xD;
&#xD;
          -  Planned surgery or drug intervention during the study period&#xD;
&#xD;
          -  Allergy or intolerance to constraint intervention materials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>julie werner</investigator_full_name>
    <investigator_title>Clinical Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neonatal Brachial Plexus 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/NCT03765034
org study id: CCI-10-00255
nct id: NCT03765034
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care
      occupational therapy in children with perinatal brachial plexus injury. Participants are
      randomized to receive either the intervention (CIMT) or control first, then cross over to
      receive the other one.
Children with perinatal brachial plexus injury routinely receive occupational therapy
      intervention to improve strength and function in their weak or paralyzed arm.

      Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in
      children with weakness or disuse as a result of cerebral palsy. However, it is unknown if
      this therapy is effective for treating arm weakness or disuse as a result of perinatal
      brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care
      is evaluated in this trial.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Assisting Hand Assessment 5.0
time frame: change from baseline at 8 weeks and 16 weeks
description: Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.
arm group label: Constraint-induced Movement Therapy
arm group type: Experimental
description: A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.
arm group label: Usual Occupational Therapy
arm group type: Active Comparator
description: Usual and standard care occupational therapy is administered for 8 weeks.
intervention type: Behavioral
intervention name: Constrain-induced Movement Therapy
description: 8-week therapy program utilizing constraint of the unaffected arm
arm group label: Constraint-induced Movement Therapy
intervention type: Behavioral
intervention name: Usual Occupational Therapy
description: 8-week therapy program without constraint of the unaffected arm
arm group label: Constraint-induced Movement Therapy
arm group label: Usual Occupational Therapy
criteria: 
gender: All
minimum age: 12 Months
maximum age: 5 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: julie werner
investigator title: Clinical Scientist
mesh term: Neonatal Brachial Plexus Palsy