An interventional study of Sup-ER Protocol and Control in Birth Related Brachial Plexus Injury and Obstetrical Brachial Plexus Palsy, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 6 Weeks to 8 Weeks. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early shoulder repositioning (Sup-ER Splint)
Other: Sup-ER Protocol
Standard treatment
Other: Control
Early shoulder repositioning (Sup-ER Splint)
Standard treatment
Toronto Active Movement Scale
Time frame: 1 year of age
This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Neonatal Brachial Plexus Palsy
University of British Columbia