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Sup-ER Splint for Children With Birth Related Brachial Plexus Injury

Primary Purpose

Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sup-ER Splint
Currently accepted treatment
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Birth Related Brachial Plexus Injury focused on measuring birth related brachial plexus injury, brachial plexus, splint

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of brachial plexus injury at birth.
  • Significant deficit in external rotation and/or supination of the affected limb based on clinical assessment using the Toronto Active Movement Scale at 6 weeks of age: External Rotation ≤ 2 and/or Supination ≤ 2
  • Tightness in Passive Range of Motion of external rotation: any angle of less than 180°.
  • Age 6-8 weeks for complete protocol fulfillment.

Exclusion Criteria:

  • Neuromuscular disorder.
  • Unwillingness or inability to comply with the requirements of this protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sup-ER Splint

    Control (Currently accepted treatment)

    Arm Description

    Experimental group that will receive Sup-ER splint.

    Control group that will receive the currently accepted treatment.

    Outcomes

    Primary Outcome Measures

    Toronto Active Movement Scale

    Secondary Outcome Measures

    Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
    The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.

    Full Information

    First Posted
    August 9, 2012
    Last Updated
    November 14, 2017
    Sponsor
    University of British Columbia
    Collaborators
    Children's & Women's Health Centre of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01663428
    Brief Title
    Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
    Official Title
    Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    It was decided to change the study from a cohort to a randomized controlled trial.
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    August 2015 (Anticipated)
    Study Completion Date
    August 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia
    Collaborators
    Children's & Women's Health Centre of British Columbia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy
    Keywords
    birth related brachial plexus injury, brachial plexus, splint

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sup-ER Splint
    Arm Type
    Experimental
    Arm Description
    Experimental group that will receive Sup-ER splint.
    Arm Title
    Control (Currently accepted treatment)
    Arm Type
    Active Comparator
    Arm Description
    Control group that will receive the currently accepted treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Sup-ER Splint
    Other Intervention Name(s)
    Splint
    Intervention Type
    Other
    Intervention Name(s)
    Currently accepted treatment
    Primary Outcome Measure Information:
    Title
    Toronto Active Movement Scale
    Time Frame
    1 year of age
    Secondary Outcome Measure Information:
    Title
    Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
    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.
    Time Frame
    6 months of age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    8 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of brachial plexus injury at birth. Significant deficit in external rotation and/or supination of the affected limb based on clinical assessment using the Toronto Active Movement Scale at 6 weeks of age: External Rotation ≤ 2 and/or Supination ≤ 2 Tightness in Passive Range of Motion of external rotation: any angle of less than 180°. Age 6-8 weeks for complete protocol fulfillment. Exclusion Criteria: Neuromuscular disorder. Unwillingness or inability to comply with the requirements of this protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cynthia Verchere, MD FRCSC
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Sup-ER Splint for Children With Birth Related Brachial Plexus Injury

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