Trial record 2 of 33 for:    Brachial Plexus Injuries

Sup-ER Splint for Children With Birth Related Brachial Plexus Injury

This study has been withdrawn prior to enrollment.
(It was decided to change the study from a cohort to a randomized controlled trial.)
Sponsor:
Collaborator:
Children's & Women's Health Centre of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01663428
First received: August 9, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

This study evaluates the ability of a newly designed splint called "Sup-ER Splint" 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 Splint
Other: Currently accepted treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) [ Time Frame: 6 months of age ] [ Designated as safety issue: No ]
    The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.


Enrollment: 0
Study Start Date: July 2012
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sup-ER Splint
Experimental group that will receive Sup-ER splint.
Other: Sup-ER Splint
Other Name: Splint
Active Comparator: Control (Currently accepted treatment)
Control group that will receive the currently accepted treatment.
Other: Currently accepted 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. One almost universally common outcome, even in children with otherwise "good" recovery, is that the motions of external rotation of the shoulder and supination of the forearm are weaker, later to recover, and often incomplete. Even beyond these direct functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance of these motions can interfere with other upper extremity movements like elbow flexion, even when elbow flexion itself is well recovered. 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. Surgery cannot completely correct this deformity. 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 and has significantly changed the care received by patients in BC. This study will evaluate the use of Sup-ER splint in multiple centres over a five year period by assessing the arm function at common time points in recovery.

  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 for complete protocol fulfillment.

Exclusion Criteria:

  • Neuromuscular disorder.
  • Unwillingness or inability to comply with the requirements of this 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: NCT01663428

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: NCT01663428     History of Changes
Other Study ID Numbers: H12-00776
Study First Received: August 9, 2012
Last Updated: August 28, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 16, 2014