Trial record 3 of 33 for:    Brachial Plexus Injuries

Sup-ER Protocol RCT

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of British Columbia
Sponsor:
Collaborator:
Children's & Women's Health Centre of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01933438
First received: August 28, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933438

Contacts
Contact: Marija Bucevska, MD 604.875.2525 mbucevska@cw.bc.ca

Locations
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Marija Bucevska, MD    604.875.2525    mbucevska@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Children's & Women's Health Centre of British Columbia
Investigators
Principal Investigator: Cynthia Verchere, MD FRCSC University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01933438     History of Changes
Other Study ID Numbers: H13-00751
Study First Received: August 28, 2013
Last Updated: March 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
birth related brachial plexus injury
brachial plexus
splint

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014