Sup-ER Protocol RCT

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.

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.

Study Overview

• Status: Terminated
• Conditions: Birth Related Brachial Plexus Injury; Obstetrical Brachial Plexus Palsy
• Intervention / Treatment: Other: Sup-ER Protocol; Other: Control

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • BC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Children's & Women's Health Centre of British Columbia
• Investigators: Principal Investigator: Cynthia Verchere, MD FRCSC, University of British Columbia

Publications and helpful links

Helpful Links

• SPLINTING FOR PERIPHERAL NERVE INJURY IN UPPER LIMB

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: brachial plexus; splint; birth related brachial plexus injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Birth Injuries; Brachial Plexus Neuropathies; Neonatal Brachial Plexus Palsy
• Other Study ID Numbers: H13-00751