- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01663428
Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
November 14, 2017 updated by: Cynthia Verchere, University of British Columbia
Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?
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.
Study Overview
Status
Withdrawn
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.
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.
Study Type
Interventional
Phase
- Not Applicable
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 month to 1 month (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 for complete protocol fulfillment.
Exclusion Criteria:
- Neuromuscular disorder.
- Unwillingness or inability to comply with the requirements of this 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sup-ER Splint
Experimental group that will receive Sup-ER splint.
|
Other Names:
|
Active Comparator: Control (Currently accepted treatment)
Control group that will receive the currently accepted treatment.
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
Time Frame: 6 months of age
|
The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
|
6 months of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
July 1, 2012
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
August 9, 2012
First Submitted That Met QC Criteria
August 10, 2012
First Posted (Estimate)
August 13, 2012
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-00776
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.
Clinical Trials on Birth Related Brachial Plexus Injury
-
University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
-
All India Institute of Medical Sciences, New DelhiCompletedBrachial Plexus InjuryIndia
-
Centre Hospitalier Universitaire VaudoisWithdrawnBrachial Plexus InjurySwitzerland
-
Ataturk UniversityNot yet recruitingBrachial Plexus Injury | Elasticity Imaging Techniques
-
Assiut UniversityNot yet recruiting
-
Siriraj HospitalLerdsin General HospitalCompleted
-
Leiden University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknownBrachial Plexus InjuryNetherlands
-
University of AlbertaRoyal Alexandra Hospital; Glenrose FoundationNot yet recruiting
-
Carilion ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingBrachial Plexus InjuryUnited States
-
Emine AtıcıCompletedObstetric Brachial Plexus InjuryTurkey
Clinical Trials on Sup-ER Splint
-
University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruitingThyroid Cancer | Lymph Node Metastases | Positron-Emission TomographyChina
-
Federal University of São PauloCompleted
-
University of FloridaWithdrawnCarpometacarpal (CMC) Joint ArthritisUnited States
-
University of AlbertaCompleted
-
Istituti Clinici Scientifici Maugeri SpAActive, not recruiting
-
Mardin Artuklu UniversityCompletedCarpal Tunnel Syndrome | Pregnancy Related | SplintsTurkey
-
Cairo UniversityUnknown
-
St Helens & Knowsley Teaching Hospitals NHS TrustWithdrawn
-
Rambam Health Care CampusCompletedHand Tendon InjuryIsrael