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.
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
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.