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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663428
Recruitment Status : Withdrawn (It was decided to change the study from a cohort to a randomized controlled trial.)
First Posted : August 13, 2012
Last Update Posted : November 17, 2017
Children's & Women's Health Centre of British Columbia
Information provided by (Responsible Party):
Cynthia Verchere, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Birth Related Brachial Plexus Injury Obstetrical Brachial Plexus Palsy Other: Sup-ER Splint Other: Currently accepted treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Sup-ER Splint
Experimental group that will receive Sup-ER splint.
Other: Sup-ER Splint
Other Name: Splint

Active Comparator: Control (Currently accepted treatment)
Control group that will receive the currently accepted treatment.
Other: Currently accepted treatment

Primary Outcome Measures :
  1. Toronto Active Movement Scale [ Time Frame: 1 year of age ]

Secondary Outcome Measures :
  1. Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) [ Time Frame: 6 months of age ]
    The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01663428

Sponsors and Collaborators
University of British Columbia
Children's & Women's Health Centre of British Columbia
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Principal Investigator: Cynthia Verchere, MD FRCSC University of British Columbia
Additional Information:
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Responsible Party: Cynthia Verchere, Principle Investigator, University of British Columbia Identifier: NCT01663428    
Other Study ID Numbers: H12-00776
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Cynthia Verchere, University of British Columbia:
birth related brachial plexus injury
brachial plexus
Additional relevant MeSH terms:
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Neonatal Brachial Plexus Palsy
Wounds and Injuries
Brachial Plexus Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Birth Injuries
Infant, Newborn, Diseases