<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/NCT01663428</url>
  </required_header>
  <id_info>
    <org_study_id>H12-00776</org_study_id>
    <nct_id>NCT01663428</nct_id>
  </id_info>
  <brief_title>Sup-ER Splint for Children With Birth Related Brachial Plexus Injury</brief_title>
  <official_title>Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's &amp; Women's Health Centre of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the ability of a newly designed splint called &quot;Sup-ER Splint&quot; to improve&#xD;
      the arm function and anatomy of children with birth related brachial plexus injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The brachial plexus is a group of 5 nerves from the spinal cord that provide the movement and&#xD;
      sensation of an upper extremity. In some difficult deliveries, traction on the shoulder may&#xD;
      lead to damage to the brachial plexus and will result in an arm that is paralyzed. This is&#xD;
      called 'birth related brachial plexus injury' (BRBPI). This may occur in up to 1/1000 births&#xD;
      and the nerves may be injured minimally to severely. About 2/3 of children with this injury&#xD;
      will recover to quite functional levels simply by maintaining looseness of joints while their&#xD;
      nerves slowly heal. Some children have nerve injuries severe enough that they require&#xD;
      surgical reconstruction with nerve grafts and nerve transfers to achieve even adequate&#xD;
      function. One almost universally common outcome, even in children with otherwise &quot;good&quot;&#xD;
      recovery, is that the motions of external rotation of the shoulder and supination of the&#xD;
      forearm are weaker, later to recover, and often incomplete. Even beyond these direct&#xD;
      functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance&#xD;
      of these motions can interfere with other upper extremity movements like elbow flexion, even&#xD;
      when elbow flexion itself is well recovered. More importantly, lack of full motion leads to&#xD;
      long term changes in the structure, growth, and posture of the shoulder requiring further&#xD;
      musculoskeletal surgery, or a child with permanent deformity or disability. Surgery cannot&#xD;
      completely correct this deformity. Any gains in active and passive range of motion during the&#xD;
      first year of life may improve these long-term shoulder outcomes. The investigators have&#xD;
      instituted a program of early passive repositioning mostly using a custom Sup-ER (Supination&#xD;
      and External Rotation) splint during early growth and development to improve arm position and&#xD;
      range of motion where ER and Sup are weak. In compliant patients in a pilot study, the speed&#xD;
      and strength of recovery of ER and Supination are improved compared to historical controls.&#xD;
      It is a novel splint and protocol designed by the investigators and has significantly changed&#xD;
      the care received by patients in BC. This study will evaluate the use of Sup-ER splint in&#xD;
      multiple centres over a five year period by assessing the arm function at common time points&#xD;
      in recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    It was decided to change the study from a cohort to a randomized controlled trial.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toronto Active Movement Scale</measure>
    <time_frame>1 year of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)</measure>
    <time_frame>6 months of age</time_frame>
    <description>The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Birth Related Brachial Plexus Injury</condition>
  <condition>Obstetrical Brachial Plexus Palsy</condition>
  <arm_group>
    <arm_group_label>Sup-ER Splint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group that will receive Sup-ER splint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (Currently accepted treatment)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group that will receive the currently accepted treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sup-ER Splint</intervention_name>
    <arm_group_label>Sup-ER Splint</arm_group_label>
    <other_name>Splint</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Currently accepted treatment</intervention_name>
    <arm_group_label>Control (Currently accepted treatment)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of brachial plexus injury at birth.&#xD;
&#xD;
          -  Significant deficit in external rotation and/or supination of the affected limb based&#xD;
             on clinical assessment using the Toronto Active Movement Scale at 6 weeks of age:&#xD;
             External Rotation ≤ 2 and/or Supination ≤ 2&#xD;
&#xD;
          -  Tightness in Passive Range of Motion of external rotation: any angle of less than&#xD;
             180°.&#xD;
&#xD;
          -  Age 6-8 weeks for complete protocol fulfillment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular disorder.&#xD;
&#xD;
          -  Unwillingness or inability to comply with the requirements of this protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>8 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia Verchere, MD FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Cynthia Verchere</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>birth related brachial plexus injury</keyword>
  <keyword>brachial plexus</keyword>
  <keyword>splint</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neonatal Brachial Plexus Palsy</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT01663428
org study id: H12-00776
nct id: NCT01663428
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the ability of a newly designed splint called "Sup-ER Splint" to improve
      the arm function and anatomy of children with birth related brachial plexus injuries.
The brachial plexus is a group of 5 nerves from the spinal cord that provide the movement and
      sensation of an upper extremity. In some difficult deliveries, traction on the shoulder may
      lead to damage to the brachial plexus and will result in an arm that is paralyzed. This is
      called 'birth related brachial plexus injury' (BRBPI). This may occur in up to 1/1000 births
      and the nerves may be injured minimally to severely. About 2/3 of children with this injury
      will recover to quite functional levels simply by maintaining looseness of joints while their
      nerves slowly heal. Some children have nerve injuries severe enough that they require
      surgical reconstruction with nerve grafts and nerve transfers to achieve even adequate
      function. One almost universally common outcome, even in children with otherwise "good"
      recovery, is that the motions of external rotation of the shoulder and supination of the
      forearm are weaker, later to recover, and often incomplete. Even beyond these direct
      functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance
      of these motions can interfere with other upper extremity movements like elbow flexion, even
      when elbow flexion itself is well recovered. More importantly, lack of full motion leads to
      long term changes in the structure, growth, and posture of the shoulder requiring further
      musculoskeletal surgery, or a child with permanent deformity or disability. Surgery cannot
      completely correct this deformity. Any gains in active and passive range of motion during the
      first year of life may improve these long-term shoulder outcomes. The investigators have
      instituted a program of early passive repositioning mostly using a custom Sup-ER (Supination
      and External Rotation) splint during early growth and development to improve arm position and
      range of motion where ER and Sup are weak. In compliant patients in a pilot study, the speed
      and strength of recovery of ER and Supination are improved compared to historical controls.
      It is a novel splint and protocol designed by the investigators and has significantly changed
      the care received by patients in BC. This study will evaluate the use of Sup-ER splint in
      multiple centres over a five year period by assessing the arm function at common time points
      in recovery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toronto Active Movement Scale
time frame: 1 year of age
measure: Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
time frame: 6 months of age
description: The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
arm group label: Sup-ER Splint
arm group type: Experimental
description: Experimental group that will receive Sup-ER splint.
arm group label: Control (Currently accepted treatment)
arm group type: Active Comparator
description: Control group that will receive the currently accepted treatment.
intervention type: Other
intervention name: Sup-ER Splint
arm group label: Sup-ER Splint
other name: Splint
intervention type: Other
intervention name: Currently accepted treatment
arm group label: Control (Currently accepted treatment)
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 8 Weeks
healthy volunteers: No
last name: Cynthia Verchere, MD FRCSC
role: Principal Investigator
affiliation: University of British Columbia
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Cynthia Verchere
investigator title: Principle Investigator
mesh term: Neonatal Brachial Plexus Palsy
mesh term: Wounds and Injuries