跳至主要内容
临床试验/NCT01933438
NCT01933438终止不适用

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.

University of British Columbia2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Toronto Active Movement Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Weeks 至 8 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Neuromuscular disorder
  • Unwillingness or inability to comply with the requirements of the study protocol.

研究组 & 干预措施

Sup-ER protocol

Experimental

Early shoulder repositioning (Sup-ER Splint)

干预措施: Sup-ER Protocol (Other)

Control

Active Comparator

Standard treatment

干预措施: Control (Other)

结局指标

主要结局

Toronto Active Movement Scale

时间窗: 1 year of age

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Verchere

Principle Investigator

University of British Columbia

研究点 (2)

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