Shepherd Center Researchers Making Research More Meaningful
Clinicians and researchers partner with patients in pragmatic clinical trials at Shepherd Center.
By Edelle Field-Fote, PT, Ph.D., FAPTA
Director of SCI Research and Co-Project Director, Shepherd Center SCIMS Program
When a young person thinks about having a career in research, he or she may envision days spent testing exciting new ideas. As a rehabilitation researcher, this involves testing new ways to help people with disability move and function in daily life.
For many years, rehabilitation researchers have designed studies in a way that is much like the studies done by drug companies, using a design called the randomized clinical trial (RCT). An RCT is designed to test cause-and-effect relationships, and for this reason, it is often referred to as an explanatory study. However, more and more, we are understanding that the RCT design may not be the best approach for rehabilitation research. The major drawback of the RCT approach is that many of the elements of an RCT study are different from the way things work in the real world of the clinic. For this reason, the ability to apply the findings from a RCT in a clinical setting may be limited.
There are a number of elements that make the RCT different from the real world of clinical practice. For instance, in an RCT there may be strict criteria about who may be included in the study. This strict inclusion criteria means the results may not be applicable for people are not exactly like those who were in the study. For example, the inclusion criteria may allow participation only by people between two and six months after injury. Another difference is that the treatment delivered as part of the RCT may not be practical in the real world, or the treatment may be delivered in a way that is not practical in the real world. For instance, a treatment that requires expensive, high-tech equipment and highly trained personnel is not likely to be widely available in a real-world setting.
An increasingly popular alternative to the RCT is the pragmatic clinical trial (PCT,) sometimes also called a practical study. In a PCT, the study is not designed to test cause-and-effect relationships, but instead to help make choices about practical options for treatment. The treatment is delivered in settings where everyday care happens, and it can be delivered to a diverse range of participants who represent the variety of ways that people with the disability might appear. An important element of the PCT is that the measures used to determine whether the treatment is valuable must be measures that are meaningful to the patients who are participating.
The clinicians at Shepherd Center are known for their contributions to improving the care of individuals with spinal cord injury. They also have a long history of involvement in research. For this reason, partnering with the clinicians to do research studies at Shepherd Center was the obvious route to take when we, the researchers, received research grants from the Department of Defense (DOD) and the National Institutes of Health (NIH). These studies combine the most valuable elements of both the RCT and PCT designs, rather than being strictly one or the other.
The study funded by the DOD will help determine whether adding non-invasive brain stimulation to fine-motor training improves hand function more than fine-motor training alone. Shepherd’s expert occupational therapy clinicians will provide fine-motor training using the approach they have found to be most useful. The non-invasive brain stimulation that will be added to the treatment uses a relatively inexpensive and widely available device. If the results indicate non-invasive brain stimulation makes the training more effective, then this could make the approach practical for use in a clinical setting.
The NIH-funded study focuses on the potential value of whole-body vibration. Working alongside Shepherd Center staff involved in locomotor training, this study will evaluate whether this widely available device has a meaningful influence on reducing spasticity and increasing the effects of locomotor training.
By combining our efforts, the clinicians and researchers at Shepherd Center make up a team where the whole is greater than the sum of its parts – and with practical benefits for making real-world care the best it can be.
More information about Shepherd Center research and how to participate is available here.
EDELLE FIELD-FOTE, PT, Ph.D., is the director of spinal cord injury research at Shepherd Center. She joined the staff in May 2014 after serving for 20 years as the director of the Neuromotor Rehabilitation Research Laboratory at the Miami Project to Cure Paralysis. Her research focuses on restoring motor function after spinal cord injury by making use of spinal pathways not damaged by injury.
Shepherd Center provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, multiple amputations, stroke, multiple sclerosis, and pain. Ranked by U.S. News as one of the nation’s top 10 hospitals for rehabilitation and the best in the Southeast, Shepherd Center treats more than 850 inpatients and 7,600 outpatients annually with unmatched expertise and unwavering compassion to help them begin again.