Birth Related Brachial Plexus InjuryNCT01663428
Sup-ER Splint for Children With Birth Related Brachial Plexus Injury
A study testing Sup-ER Splint and Currently accepted treatment in people with Birth Related Brachial Plexus Injury and Obstetrical Brachial Plexus Palsy, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 weeks
- Conditions the study is for
- Birth Related Brachial Plexus Injury, Obstetrical Brachial Plexus Palsy
- What is being tested?
- Sup-ER Splint and Currently accepted treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Neuromuscular disorder.
- Unwillingness or inability to comply with the requirements of this protocol.
About this study
Official title: Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?
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.
Read the 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. One almost universally common outcome, even in children with otherwise "good" recovery, is that the motions of external rotation of the shoulder and supination of the forearm are weaker, later to recover, and often incomplete. Even beyond these direct functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance of these motions can interfere with other upper extremity movements like elbow flexion, even when elbow flexion itself is well recovered. 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. Surgery cannot completely correct this deformity. 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 and has significantly changed the care received by patients in BC. This study will evaluate the use of Sup-ER splint in multiple centres over a five year period by assessing the arm function at common time points in recovery.
- Being tested
- Sup-ER Splint, Currently accepted treatment
- Keywords
- birth related brachial plexus injury, brachial plexus, splint
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sup-ER SplintOther
Also called Splint
Currently accepted treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Sup-ER Splint | Experimental | Experimental group that will receive Sup-ER splint. Receives: Other: Sup-ER Splint |
| Control (Currently accepted treatment) | Active comparator | Control group that will receive the currently accepted treatment. Receives: Other: Currently accepted treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Active Movement Scale
Measured: 1 year of age
Secondary outcomes (1)
Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
The Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH) will be measured at baseline and 6 months of age by ultrasound.
Measured: 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2019 (estimated)
Why it stopped: It was decided to change the study from a cohort to a randomized controlled trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Related Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's & Women's Health Centre of British Columbia
- Responsible party
- Principal investigator, Cynthia Verchere, University of British Columbia
- Investigators
- Cynthia Verchere, MD FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663428
- Sponsor's protocol ID
- H12-00776
- Status last verified
- Nov 2017
- First submitted
- 9 Aug 2012
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sup-ER Splinting: Does Early Passive Positioning in Supination and External Rotation in Children With Birth Related Brachial Plexus Injury Have Benefit?
- ClinicalTrials.gov ID
- NCT01663428
- Acronym / sponsor ID
- H12-00776
- Keywords
- birth related brachial plexus injury, brachial plexus, splint
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided to change the study from a cohort to a randomized controlled trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Children's & Women's Health Centre of British Columbia
- Study start
- Jul 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. One almost universally common outcome, even in children with otherwise "good" recovery, is that the motions of external rotation of the shoulder and supination of the forearm are weaker, later to recover, and often incomplete. Even beyond these direct functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance of these motions can interfere with other upper extremity movements like elbow flexion, even when elbow flexion itself is well recovered. 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. Surgery cannot completely correct this deformity. 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 and has significantly changed the care received by patients in BC. This study will evaluate the use of Sup-ER splint in multiple centres over a five year period by assessing the arm function at common time points in recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sup-ER Splint | Experimental | Other: Sup-ER SplintExperimental group that will receive Sup-ER splint. |
| Control (Currently accepted treatment) | Active comparator | Other: Currently accepted treatmentControl group that will receive the currently accepted treatment. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Neuromuscular disorder.
- Unwillingness or inability to comply with the requirements of this protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sup-ER SplintAlso: Splint | Other | Sup-ER Splint |
| Currently accepted treatment | Other | Control (Currently accepted treatment) |
Primary outcome
Toronto Active Movement Scale
Time frame: 1 year of age
1 secondary outcome
Alpha angle (glenoid version) and posterior displacement of humeral head (PDHH)
Time frame: 6 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- SPLINTING FOR PERIPHERAL NERVE INJURY IN UPPER LIMBLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Verchere, MD FRCSC principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Sup-ER Splint and Currently accepted treatment in people with Birth Related Brachial Plexus Injury and Obstetrical Brachial Plexus Palsy, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Active Movement Scale (time frame: 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.