2 to 6 Year Olds Diagnosed with Neonatal Brachial Plexus Injury Needed for a Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about whether the use of a dynamic splint with neuromuscular electrical stimulation is more effective than a dynamic splint alone for the treatment of elbow flexion contractures in children with neonatal brachial plexus injuries.

Treatments for neonatal brachial plexus injuries currently vary. We would like to know whether neuromuscular electrical stimulation provides an added benefit to dynamic splinting by producing active stretching. 

 

Who can participate?

Children, 2 to 6 years old, who have:

 

  • A Diagnosis of neonatal brachial plexus injury
  • Elbow flexion contracture greater than 20 degrees
  • No other co-existing heart problems, epilepsy or any implanted electrical devices
  • Previous elbow surgery 
 

 

Conditions

  • Brachial-Plexus

What will happen in the study?

If your child qualifies, and you decide you want them to participate, your child will be asked to come to Cincinnati Children’s for several 15-minute clinic visits, which will happen a few days, 1 month, 2 months and 1 year from the day he or she begins treatment. Your child will be part of this study for 1 year.

Your child will be "randomized" into 1 of 2 study groups, each receiving a different form of treatment:

  • Active stretching as treatment
  • Passive stretching as treatment

Being randomized means your child will be put into a study group by chance, like flipping a coin. Your child will have an equal chance of being in either study group.

At the initial clinic visit , your child will undergo a physical exam to assess pain and range of motion. Children in the passive stretching group will also receive a dynamic splint while children in the active stretching group will receive a dynamic splint as well as a neuromuscular electrical stimulation unit.

You, as the parent or guardian, will be required to complete a daily log every day at home, recording the date, length of time using the splint, and pain. If your child has the neuromuscular electrical stimulation unit, it will electronically record your child’s use

Depending on his or her treatment group, your child will use either the dynamic splint or dynamic splint/neuromuscular electrical stimulation unit together for 30 minutes once a day for the first 3 days of the study .

Your child will then change their usage of either the dynamic splint or dynamic splint/neuromuscular electrical stimulation unit to 30 minutes twice a day . Your child will follow this schedule for 2 months .

At 2 months , your child will finish using the dynamic splint or dynamic splint/neuromuscular electrical stimulation unit and will undergo a physical exam to assess pain and range of motion.

At 1 year , your child will undergo a final physical exam to assess pain and range of motion.

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

 

What are the good things that can happen from this research?

Being in this study may not help your child right now. However, it is possible that the treatment your child will receive may help to directly improve his or her elbow extension.

When we finish the research, we expect to know more about the effectiveness of active stretching treatment in improving elbow extension when it involves a combination of dynamic splinting and neuromuscular electrical stimulation. This may help other children with elbow flexion contractures later on.

What are the bad things that can happen from this research?

The research study procedures may cause some minimal side effects. A detailed list of those possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study.

 

 

Will you/your child be paid to be in this research study?

Participants will not be reimbursed for their participation in this study. 

Contact

Contact Us.Emily Louden
emily.louden@cchmc.org
513-636-6972
 Cincinnati Children’s Hospital Medical Center
Division of Orthopaedics
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Roger Cornwall, MD
Cincinnati Children’s Hospital Medical Center
Director, Hand and Upper Extremity Center
Division of Orthopaedics