Cerebral Palsy Study for Children 4 to 12
What is the purpose of this study?
Cincinnati Children's is conducting a research study to learn how to measure change in children with cerebral palsy. As a result of this study, we hope to better understand how treatments impact different groups of children with cerebral palsy.
Who will be included in this study?
Children with cerebral palsy between the ages of 4 and 12 may be eligible to participate in this study.
What is involved?
The study lasts for 6 months and includes 3 visits. Change will be looked at and measured in the child's quality of life, motor functions and the extent to which they can take care of their personal needs such as brushing their teeth and dressing themselves. The following is a list of procedures that will take place during the study:
- Gross Motor Function Measure (GMFM), an evaluation in which a therapist will assess the child's motor functions. This is very much like a physical therapy visit.
- Pediatric Evaluation of Disability Inventory (PEDI), an evaluation in which a therapist will ask the parent/guardian about functional skills and caregiver assistance.
- Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL), an evaluation given through a questionnaire which asks the parent/guardian and the child (if able) about how the child feels about aspects of his/her life such as family, friends and school.
What are the benefits?
Your child may receive no direct benefit from participating in this study. The benefit may be that your child will be helping other children. Clinical studies are essential in evaluating new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents interested in having their 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/guardian has signed this form and, of age, the child has given at minimum his/her verbal agreement.
What are the risks?
There are no risks associated with this study.
What is the compensation?
Parents and participants will receive compensation for time and travel.
Who should I contact for more information?
Lauren Kennington
Cincinnati Children's Hospital Medical Center
Department of Pediatric Rehabilitation, MLC 4009
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-7506
lauren.kennington@cchmc.org
