6 to 17 Year Olds with Unilateral Brachial Plexus OR Hemiplegic Cerebral Palsy 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 arm muscle structure and function in children with cerebral palsy or neonatal brachial plexus injury who have elbow flexion contractures.

We will look at how the length of sarcomeres, the smallest units of muscle, in the biceps and brachialis muscles (on the affected side) relates to arm strength and the ability to move the arm. We would also like to know whether the elbow flexion contractures that sometimes occur with these two conditions are related to weakness and shortening of the biceps and brachialis muscles.

 

Who can participate?

Children and teens, 6 to 17 years old, who have:

 

  • A diagnosis of unilateral neonatal brachial plexus injury OR hemiplegic cerebral palsy
  • Elbow flexion contraction between 10 and 90 degrees
  • No previous elbow treatment
Your child must be undergoing a non-elbow related surgery under general anesthesia to be eligible for participation.
 

 

Conditions

  • Brachial-Plexus

Gender

  • Female
  • Male

What will happen in the study?

If your child qualifies, and you decide you want them to be in the study, your child will have 3 visits at Cincinnati Children’s for this research.

The study will be explained to you and your child during your regular clinic visit. This will be considered the first research visit .  

You and your child will be asked to visit our Motion Analysis Lab up to 4 weeks before your child’s scheduled surgery for the second research visit .

During this 30-minute visit, the strength of both of your child’s arms will be measured. We will do this by placing an electrode over your child’s biceps and have him/her do 10 flexion/extension cycles on a Biodex System (similar to a weight machine). These measurements are non-invasive and cause no pain.  

Your child’s scheduled surgery is also considered the third research visit .

Once your child is anesthetized (asleep) before the surgery, a thin sterile probe (the size of a needle) connected to a small camera will be inserted into your child’s upper arm (into the biceps and brachialis muscles). We will then take pictures of your child’s muscle sarcomeres and measure your child’s range of elbow motion as we move your child’s arm into different position. The probe will then be removed and this process will be repeated in the opposite arm.

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. We hope that when we finish this study, we will know more about the neuromuscular factors contributing to the elbow flexion contractures in patients with cerebral palsy and neonatal brachial plexus injury.
This may help us to develop new treatments that could help other children with these conditions 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