At Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.
In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.
The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.
Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.
During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.
“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”
Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.
Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.
“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”
The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.
Click to learn more about clinical trials at Emory, or call 404-778-7777.