NCT01663428

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Status
withdrawn

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

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3.1 years

First QC Date

August 9, 2012

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

Secondary Outcomes (1)

  • Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)

    6 months of age

Study Arms (2)

Sup-ER Splint

EXPERIMENTAL

Experimental group that will receive Sup-ER splint.

Other: Sup-ER Splint

Control (Currently accepted treatment)

ACTIVE COMPARATOR

Control group that will receive the currently accepted treatment.

Other: Currently accepted treatment

Interventions

Sup-ER SplintOTHER
Also known as: Splint
Sup-ER Splint
Currently accepted treatmentOTHER
Control (Currently accepted treatment)

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 for complete protocol fulfillment.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Interventions

Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Cynthia Verchere, MD FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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 9, 2012

First Posted

August 13, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11