Sup-ER Protocol RCT

Study Overview
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Brief Summary
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This study evaluates the ability of a supination and external rotation protocol to improve the arm function and anatomy of children with birth related brachial plexus injuries.

Detailed Description
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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. Even in children with otherwise good recovery, the motions of external rotation of the shoulder and supination of the forearm are weaker, later to recover, and often incomplete. 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. 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. This study is a randomized controlled trial to evaluate the use of the Sup-ER protocol in multiple centres over a two year period by assessing the arm function at common time points in recovery. The subjects are randomized to the Sup-ER protocol or the currently accepted standard treatment.

Official Title
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Does Early Supination and External Rotation Repositioning in Children With Birth Related Brachial Plexus Injury Have Benefit? A Randomized Controlled Trial of the Sup-ER Protocol.

Conditions
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Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy

Intervention / Treatment
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* Other: Sup-ER Protocol
* Other: Control


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Neuromuscular disorder Unwillingness or inability to comply with the requirements of the study protocol.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sup-ER protocol<br>Early shoulder repositioning (Sup-ER Splint) | Other: Sup-ER Protocol<br>* Early shoulder repositioning (Sup-ER Splint)<br>|
| Active Comparator: Control<br>Standard treatment | Other: Control<br>* Standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Active Movement Scale |  | 1 year of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth related brachial plexus injury, brachial plexus, splint