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Sup-ER Protocol RCT

This study has been terminated.
(The study ended early after encountering logistics challenges and difficulties with site recruitment.)
Children's & Women's Health Centre of British Columbia
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: August 28, 2013
Last updated: July 24, 2015
Last verified: July 2015
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 Intervention
Birth Related Brachial Plexus Injury Obstetrical Brachial Plexus Palsy Other: Sup-ER Protocol Other: Control

Study Type: Interventional
Study Design: 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.

Further study details as provided by University of British Columbia:

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

Enrollment: 2
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

Exclusion Criteria:

  • Neuromuscular disorder
  • Unwillingness or inability to comply with the requirements of the study protocol.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01933438

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
Principal Investigator: Cynthia Verchere, MD FRCSC University of British Columbia
  More Information

Additional Information:
Responsible Party: University of British Columbia Identifier: NCT01933438     History of Changes
Other Study ID Numbers: H13-00751
Study First Received: August 28, 2013
Last Updated: July 24, 2015

Keywords provided by University of British Columbia:
birth related brachial plexus injury
brachial plexus
splint processed this record on August 22, 2017