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Sup-ER Protocol RCT

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ClinicalTrials.gov Identifier: NCT01933438
Recruitment Status : Terminated (The study ended early after encountering logistics challenges and difficulties with site recruitment.)
First Posted : September 2, 2013
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Children's & Women's Health Centre of British Columbia
Information provided by (Responsible Party):
Cynthia Verchere, University of British Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Birth Related Brachial Plexus Injury Obstetrical Brachial Plexus Palsy Other: Sup-ER Protocol Other: Control 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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sup-ER protocol
Early shoulder repositioning (Sup-ER Splint)
 Other: Sup-ER Protocol
Early shoulder repositioning (Sup-ER Splint)
Active Comparator: Control
Standard treatment
 Other: Control
Standard treatment


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

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

Exclusion Criteria:

  • Neuromuscular disorder
  • Unwillingness or inability to comply with the requirements of the study protocol.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01933438


Locations
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Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Children's & Women's Health Centre of British Columbia
Investigators
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Principal Investigator: Cynthia Verchere, MD FRCSC University of British Columbia
More Information
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Additional Information:

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Responsible Party: Cynthia Verchere, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01933438    
Other Study ID Numbers: H13-00751
First Posted: September 2, 2013    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
splint
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