WHY DO RESEARCH IN CHILDREN
According to the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health, “…children are not little adults. But without research in children themselves, we have no choice but to treat them that way.”
There are a number of reasons why research in children is so important as identified by the NHLBI.
- Children’s brains and musculoskeletal systems are developing.
- Medicines, devices, and treatments are often not tested in children.
- To continue to do research in children says to us as a society that children are important, are valued, and that we value their health.
- “We need to continue to do research in children to protect them, to improve outcomes, to enhance quality of life, and to make them ultimately healthier adults,” stated Victoria Pemberton, RNC.
One parent when considering enrolling her child into a research study, said to her child, “We hope that this helps you, but if not, we hope that it can help another young boy or girl.” At a very young age, this parent is teaching her child the meaning of altruism.
For comprehensive information about children and clinical studies, please look here.
Locomotor training, the therapy that we provide to your child today to advance recovery, was developed based on the work of both neuroscientists and clinical scientists. The neuroscientists wanted to understand the role of the spinal cord, if any, in controlling locomotion or walking. They determined that the spinal cord was in fact “smart” and highly responsive to sensory inputs (cues and information provided through sensation) and repetitive training. Similar to the brain, the spinal cord could learn through repetitive, yet a very specific type, and amount of practice. Combined with the inherent plasticity of a developing child’s nervous and musculoskeletal systems, activity-dependent plasticity is a key component of locomotor training in the clinic and at home.
These scientific findings laid the foundation for the development of locomotor training–the first activity-based therapy–changing the trajectory of outcomes for children affected by paralysis and their families. This close partnership among scientists and clinicians is at the heart of our ability to effectively and rapidly advance science into hope for recovery.
We have a comprehensive and aggressive research program aimed at achieving a new era of rehabilitation and hope for recovery in children with paralysis. There is an urgency to advance the effectiveness of our therapies, document short- and long-term effects, and develop new therapies so that children, once paralyzed, are able to more actively participate in their world and be spared surgeries, scoliosis, and hospitalizations.
Today, Kyle is an active teenager who can get around with crutches or a walker and loves to fish, swim, kayak and play paintball.
The new Pediatric NeuroRecovery Research Lab, known as “Discovery Cove,” will be used to:
- Examine ‘proof-of-principle’ for activity-based therapies,
- Assess the impact of change in sensory inputs (e.g., treadmill speed and body weight load), and
- Identify immediate effect of EMG output on muscles in children with and without injury.
KENTUCKY SPINAL CORD INJURY RESEARCH CENTER
Our partnership with the Kentucky Spinal Cord Injury Research Center is a primary reason that the Kosair Charities Center for Pediatric NeuroRecovery is able to fast-track scientific evidence into practice.
KSCIRC was opened in 2001 and is located in the Medical Dental Research Building close to the three major hospitals of the University of Louisville Health Science Center. The Center is led by Scientific Director Scott R. Whittemore, Ph.D., who is committed to further developing it into a world-class scientific and clinical research center. The Center, one of 12 spinal cord injury research centers in the United States, is in a rapid growth phase, made possible by funding and excellent cooperation between the State of Kentucky, University of Louisville and Norton Healthcare, and a recent $5.5 million grant from NIH. It is in a unique position to conduct research that, through its close association with clinical colleagues in the Department of Neurological Surgery, is expected to ultimately lead to effective treatments for spinal cord injury. This goal is guided by its mission: “to develop successful spinal cord repair strategies in the laboratory that can be taken to the clinic in a timely and responsible fashion”.
CRAWFORD SCHOLAR FELLOWSHIP
The Todd Crawford Foundation (TCF) to Cure Paralysis generously provides funds to support Crawford Scholars. The purpose of the TCF is to raise money and awareness for spinal cord injury research. In addition to donations, TCF holds a variety of charitable events throughout the year to raise funds to support research programs affiliated with the Kentucky Spinal Cord Injury Research Center (KSCIRC) at the University of Louisville. Individuals eligible to be designated Crawford Scholars are physical therapy
students, occupational therapy students, graduate or undergraduate students, medical students or postdoctoral fellows who are supported with research fellowships in the Pediatric NeuroRecovery Program.
Crawford Scholar fellowships are awarded to students for the term of a semester (fall, spring, summer) to contribute to research activities or a project that supports the mission of the Pediatric NeuroRecovery Program and enhances the academic achievement and career growth of the student. The maximum fellowship awarded for a Crawford Scholar per term is $3,000. Funds may be used to support compensation, tuition, supplies, equipment or travel to present research.
Our on-going studies are focused on four main priorities.
- First, we are seeking ways to improve the effectiveness of our activity-based therapies such that the therapy has an impact on the population of children with severe and mild disabilities.
- Second, as much of the scientific work has been conducted in adults, we are now developing our equipment for training and testing to meet the specific needs of children.
- Third, we want to understand the impact of new rehabilitative strategies on areas of particular concern for children with spinal cord injuries prior to age 12, for instance, respiration and cough to prevent pneumonia; spine growth and trunk muscle activation to prevent scoliosis; development of trunk control for sitting, standing, and walking; and bone development to prevent hip dislocation.
- Fourth, we lack good measures to assess recovery in children, in particular, and thus are developing new ways to assess both recovery and development in children who have suffered insult to their neurological systems.
WHAT ARE MY RIGHTS?
As the parent(s) and advocate for your child, you want to be fully aware of your child’s rights as a participant in research. Please read the rights below and ask us to discuss any questions that you may have.
As a participant in a research study, you have the right:
- To have enough time to decide whether or not to be in the research study and to make that decision without any pressure from the people who are conducting the research.
- To refuse to be in the study at all, and to stop participating at any time after you begin the study.
- To be told what the study is trying to find out, what will happen to you, and what you will be asked to do if you are in the study.
- To be told about the reasonably foreseeable risks of being in the study.
- To be told about the possible benefits of being in the study.
- To be told whether there are any costs associated with being in the study and whether you will be compensated for participating in the study.
- To be told who will have access to information collected about you, and how your confidentiality will be protected.
- To be told whom to contact with questions about the research, about research-related injury, and about your rights as a research subject.
If the study involves treatment or therapy:
- To be told about the other non-research treatment choices you have.
- To be told where treatment is available should you have a research-related injury, and who will pay for research-related treatment.
WHAT IS INFORMED CONSENT?
This is the way that you as a parent are given details about a study so that you can decide if your child should join the study. You are informed so that you can give your consent or okay. Nothing can happen until you give your consent to it. While there is a form to read, the discussion that you have with the research team is vital. The study team wants you to know about every detail of the study, when and what your child’s involvement will be. Take the time to ask questions, sit down and read the full informed consent document. If you still have questions, make notes to yourself and go back to the research team.
It has been found that most children from age 7 can understand basic information if given at their level. Therefore, if a child is old enough to understand the study, his or her assent may be required. Assent means “to agree to be in a study”. Often, children are asked if they agree (assent) to be in the study and to sign the assent form. These forms are a simpler version of the consent form that parents sign. Making sure that children have a say is important. However, not all studies require an assent and the age of assent varies by the study.
This information has been published and is available here.
WHAT HAPPENS IF I DECIDE NOT TO ENROLL?
If you decide not to enroll your child in a study, your child may still receive care through Kosair Charities Center for Pediatric NeuroRecovery in association with Frazier Rehab Institute.
If you feel for any reason, at any time, that you wish your child to be removed from a study, you have the right to do so.
IF WE CONSENT, WHAT’S NEXT?
If you agree to have your child participate in research, the Project Coordinator will assist you and your child in scheduling your child’s participation in the appropriate study. If you have further questions, the Project Coordinator will assist you or refer you to the appropriate resources.
NIH’S RESEARCH vs. CARE
How Research is Different from Care
Clinical research can look a lot like regular, or standard, medical care. Sometimes it is hard to tell the difference. However, research is done to find out if a treatment or procedure is good for a large group of people with a certain disease or condition. Research helps to answer questions for the future health of those populations. In contrast, standard medical care focuses on individual needs in the present.
Here are some of the ways they may be similar:
- The researcher and your health provider may be the same person.
- The setting may be your regular clinic.
- The treatments may seem the same.
National Heart, Lung and Blood Institute with the National Institutes for Health at the U.S. Department of Health and Human Services provides more detailed information about children and clinical studies.Learn More
OUR PARTNERS IN RESEARCH
Kosair Charities is funding the Kosair Charities Center for Pediatric NeuroRecovery at the University of Louisville. The Center provides a hub to 1) deliver state-of-the-art activity-based therapies to affected children with neurological disorders to promote recovery and enhance their quality of life, 2) train therapists, physicians and researchers, and 3) conduct ground-breaking research to provide the foundation for clinical decision-making, refinement, and development of novel therapies to promote neuromuscular recovery and achievement of developmentally-appropriate skills in children.
The Helmsley Charitable Trust has developed targeted programs in health, selected place-based initiatives, and education and human services, all dedicated to improving life in the U.S. and around the world. The Helmsley Charitable Trust supports pediatric rehabilitation research.
The mission of the Craig H. Neilsen Foundation is to improve the quality of life for those living with spinal cord injury and to support scientific exploration for effective therapies and treatments leading to a cure. The Craig H. Neilsen Foundation is funding the development of a new pediatric neuromuscular recovery scale for spinal cord injury.
The purpose of the Todd Crawford Foundation (TCF) is to raise money and awareness for spinal cord injury (SCI) research. TCF supports Crawford Kids, a fund that provides additional financial help for families for their child’s participation in annual follow-up research evaluations and to booster Locomotor Training sessions. TCF also funds Crawford Scholars, Physical Therapy, Medical, graduate and undergraduate students, who are supported with research fellowships in the Pediatric NeuroRecovery Laboratory.