Clinical Trials Office

12 to 17 Year Olds Who Have Had a Concussion During the Last 16 Weeks Needed for a Research Study

What is the purpose of this study?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if an exercise program can help reduce post-concussive syndrome symptoms in children. We will compare two different types of exercise programs to see how they can help with recovery after a concussion.  

Who can participate?

Children and teens, 12 to 17 years old, who have experienced a concussion less than 16 weeks ago, may be eligible for participation. 

What is involved?

Your child will have a baseline visit during which he or she will receive an evaluation to determine whether or not he or she qualifies for the study.

If your child is eligible, and you agree to have them participate, he or she will be in this study for up to 16 weeks.

While in this study, your child will complete the following evaluations and procedures:

  • Questionnaires about his or her symptoms
  • Exercise test
  • Physical exam (including height, weight, heart rate, breathing rate and blood pressure)
  • MRI scan (a way to take pictures of the body using a large magnet, radio waves and a computer)

Parents will also be asked to complete questionnaires about your child’s health, behavior and quality of life throughout the study.

Once in the study, your child will be randomly assigned (like flipping a coin) to one of two groups: the Aerobic Exercise Group or the Stretching Group.

Based on the group your child is assigned to, he or she will be taught an exercise program and be asked to come to the clinic every week for 8 weeks. At the end of the 8 weeks, your child will repeat the questionnaires, and MRI that were completed at the baseline visit.

In addition to the clinic visits, your child will be asked to do the exercises at home. Children and teens in the Aerobic Exercise Group will be loaned a stationary bicycle and be asked to ride it 5 to 6 days per week.

Children and teens in the Stretching Group will be taught a series of full body stretches and asked to do them at home 5 to 6 days per week.

Everyone will be given a FitBit device that will track the amount of physical activity and sleep they get each day.  The FitBit will be yours to keep after the study ends.

A more detailed list of procedures will be provided to anyone interested in knowing more about this study. 

What are the benefits?

Being in the study may or may not help your child’s concussion symptoms get better quicker.  

It is possible that the study will help health care providers understand how to help other children who have post-concussion symptoms. 

Will I get all the facts about the study?

You, as a parent interested in having your child participate, will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement. 

Do participants receive pay, compensation or reimbursement?

Participants will be paid up to $125 for their time and travel. 

Who should I contact for more information?

Jennifer Taylor

513-636-7506

Jennifer.taylor@cchmc.org

Cincinnati Children’s Hospital Medical Center

Division of Physical Medicine and Rehabilitation

3333 Burnet Avenue, MLC 4009

Cincinnati, OH  45229-3039 

Principal Investigator

Brad Kurowski, MD, MS                                                             

Division of Pediatric Physical Medicine and Rehabilitation

Cincinnati Children’s Hospital Medical Center