Sup-ER Protocol RCT

November 14, 2017 updated by: Cynthia Verchere, University of British Columbia

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

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year of age
1 year of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-00751

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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