6 to 21 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 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, teens and adults, 6 to 21 years old, who are undergoing a previously planned surgery under general anesthesia AND have:
- A diagnosis of unilateral neonatal brachial plexus injury OR hemiplegic cerebral palsy
- Elbow flexion contracture between 10 and 90 degrees
- No previous elbow surgery
If you (if you are a participant who is at least 18 years of age) or your child has had Botox to the affected elbow flexors within 6 months of the scheduled surgery, previous elbow surgery, phenol injections to the elbow OR are unable to perform Motion Analysis, you will not be able to participate in this research study.
- Cerebral Palsy
What will happen in the study?
If you or your child qualifies, and you decide you want to be in the study, you will have 3 visits at Cincinnati Children’s for this research.
The study will be explained to you and/or your child during the regular clinic visit. This will be considered the first research visit.
You and/or your child will be asked to visit our Motion Analysis Lab up to 4 weeks before you or your child’s scheduled surgery for the second research visit, which will test muscle strength.
During this 30-minute visit, the strength of both of you or your child’s arms will be measured. We will do this by placing an electrode over you or your child’s biceps and have you do 10 flexion/extension cycles on a Biodex System (similar to a weight machine). These measurements are non-invasive and cause no pain.
You or your child’s scheduled surgery is also considered the third research visit.
Once you or 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 the upper arm (into the biceps and brachialis muscles). We will then take pictures of you or your child’s muscle sarcomeres and measure the range of elbow motion as we move you or your child’s arm into different position. The probe will then be removed and this process will be repeated in the opposite arm.
Participants or 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 you or 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.