NCT01933438

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

August 28, 2013

Last Update Submit

November 14, 2017

Conditions

Birth Related Brachial Plexus InjuryObstetrical Brachial Plexus Palsy

Keywords

birth related brachial plexus injurybrachial plexussplint

Outcome Measures

Primary Outcomes (1)

  • Toronto Active Movement Scale

    1 year of age

Study Arms (2)

Sup-ER protocol

EXPERIMENTAL

Early shoulder repositioning (Sup-ER Splint)

Other: Sup-ER Protocol

Control

ACTIVE COMPARATOR

Standard treatment

Other: Control

Interventions

Sup-ER ProtocolOTHER

Early shoulder repositioning (Sup-ER Splint)

Sup-ER protocol
ControlOTHER

Standard treatment

Control

Eligibility Criteria

Age6 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBirth InjuriesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Cynthia Verchere, MD FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

CA(1)