Birth Related Brachial Plexus InjuryNCT01933438
Sup-ER Protocol RCT
A study testing Sup-ER Protocol in people with Birth Related Brachial Plexus Injury and Obstetrical Brachial Plexus Palsy, run by University of British Columbia at 1 site in Canada.
Trial 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. 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 Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to May 2014
- 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
Who cannot join
- Neuromuscular disorder
- Unwillingness or inability to comply with the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Early Supination and External Rotation Repositioning in Children With Birth Related Brachial Plexus Injury Have Benefit? A Randomized Controlled Trial of the Sup-ER Protocol.
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.
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. 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.
- Being tested
- Sup-ER Protocol, Control
- 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 ProtocolOther
Early shoulder repositioning (Sup-ER Splint)
ControlOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Sup-ER protocol | Experimental | Early shoulder repositioning (Sup-ER Splint) Receives: Other: Sup-ER Protocol |
| Control | Active comparator | Standard treatment Receives: Other: Control |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: The study ended early after encountering logistics challenges and difficulties with site recruitment.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT01933438
- Sponsor's protocol ID
- H13-00751
- Status last verified
- Nov 2017
- First submitted
- 28 Aug 2013
- 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
- Does Early Supination and External Rotation Repositioning in Children With Birth Related Brachial Plexus Injury Have Benefit? A Randomized Controlled Trial of the Sup-ER Protocol.
- ClinicalTrials.gov ID
- NCT01933438
- Acronym / sponsor ID
- H13-00751
- Keywords
- birth related brachial plexus injury, brachial plexus, splint
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study ended early after encountering logistics challenges and difficulties with site recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Children's & Women's Health Centre of British Columbia
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Sep 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sup-ER protocol | Experimental | Other: Sup-ER ProtocolEarly shoulder repositioning (Sup-ER Splint) |
| Control | Active comparator | Other: ControlStandard 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
Key exclusion criteria (2 listed)
- Neuromuscular disorder
- Unwillingness or inability to comply with the requirements of the study 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 ProtocolEarly shoulder repositioning (Sup-ER Splint) | Other | Sup-ER protocol |
| ControlStandard treatment | Other | Control |
Primary outcome
Toronto Active Movement Scale
Time frame: 1 year of age
Results and safety
The study was stopped early (reason given: The study ended early after encountering logistics challenges and difficulties with site recruitment.). Results are not available in the source record.
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.
Related trials for Birth Related Brachial Plexus Injury
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sup-ER Protocol in people with Birth Related Brachial Plexus Injury and Obstetrical Brachial Plexus Palsy, run by University of British Columbia at 1 site in Canada.
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: stopped early, 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.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: The study ended early after encountering logistics challenges and difficulties with site recruitment.). Results are not available in the source record.
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.