Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
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|ClinicalTrials.gov Identifier: NCT01663428|
Recruitment Status : Withdrawn (It was decided to change the study from a cohort to a randomized controlled trial.)
First Posted : August 13, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Birth Related Brachial Plexus Injury Obstetrical Brachial Plexus Palsy||Other: Sup-ER Splint Other: Currently accepted treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2019|
Experimental: Sup-ER Splint
Experimental group that will receive Sup-ER splint.
Other: Sup-ER Splint
Other Name: Splint
Active Comparator: Control (Currently accepted treatment)
Control group that will receive the currently accepted treatment.
|Other: Currently accepted treatment|
- Toronto Active Movement Scale [ Time Frame: 1 year of age ]
- Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) [ Time Frame: 6 months of age ]The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663428
|Principal Investigator:||Cynthia Verchere, MD FRCSC||University of British Columbia|