Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
Primary Purpose
Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sup-ER Splint
Currently accepted treatment
Sponsored by
About this trial
This is an interventional treatment trial for Birth Related Brachial Plexus Injury focused on measuring birth related brachial plexus injury, brachial plexus, splint
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sup-ER Splint
Control (Currently accepted treatment)
Arm Description
Experimental group that will receive Sup-ER splint.
Control group that will receive the currently accepted treatment.
Outcomes
Primary Outcome Measures
Toronto Active Movement Scale
Secondary Outcome Measures
Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
Full Information
NCT ID
NCT01663428
First Posted
August 9, 2012
Last Updated
November 14, 2017
Sponsor
University of British Columbia
Collaborators
Children's & Women's Health Centre of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01663428
Brief Title
Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
Official Title
Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
It was decided to change the study from a cohort to a randomized controlled trial.
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Children's & Women's Health Centre of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy
Keywords
birth related brachial plexus injury, brachial plexus, splint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sup-ER Splint
Arm Type
Experimental
Arm Description
Experimental group that will receive Sup-ER splint.
Arm Title
Control (Currently accepted treatment)
Arm Type
Active Comparator
Arm Description
Control group that will receive the currently accepted treatment.
Intervention Type
Other
Intervention Name(s)
Sup-ER Splint
Other Intervention Name(s)
Splint
Intervention Type
Other
Intervention Name(s)
Currently accepted treatment
Primary Outcome Measure Information:
Title
Toronto Active Movement Scale
Time Frame
1 year of age
Secondary Outcome Measure Information:
Title
Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
Description
The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
Time Frame
6 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Verchere, MD FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
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