Sup-ER Protocol RCT

NCT ID: NCT01933438

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-05-31

Brief Summary

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.

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. 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.

Conditions

Birth Related Brachial Plexus Injury; Obstetrical Brachial Plexus Palsy

Keywords

birth related brachial plexus injury; brachial plexus; splint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sup-ER protocol

Early shoulder repositioning (Sup-ER Splint)

Group Type: EXPERIMENTAL

Sup-ER Protocol

Intervention Type: OTHER

Early shoulder repositioning (Sup-ER Splint)

Control

Standard treatment

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Standard treatment

Interventions

Sup-ER Protocol

Early shoulder repositioning (Sup-ER Splint)

Intervention Type: OTHER

Control

Standard treatment

Intervention Type: OTHER

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's & Women's Health Centre of British Columbia

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Verchere

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Verchere, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://www.worldscientific.com/doi/abs/10.1142/S0218810402001229

SPLINTING FOR PERIPHERAL NERVE INJURY IN UPPER LIMB

Other Identifiers

H13-00751

Identifier Type: -

Identifier Source: org_study_id