Posts Tagged ‘clinical trials’

Stroke Rehabilitation Clinical Trial a Top International Trial

Rehab Clinical TrialAt 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.

Related Resources

Emory’s Stroke Rehabilitation Clinical Trial Chosen as Top International Trial

Rehab Clinical TrialAt 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.

Related Resources

Clinical Trials – FAQs

Clinical Trials at EmoryAt Emory Healthcare, we are proud to sponsor clinical trials and offer the opportunity for our patients to participate in them. Currently there are more than 1,000 clinical trials offered throughout our health care system. As one of the nation’s leading academic medical systems, our involvement in clinical trials sets us apart from other health care organizations. Access to advanced resources and technology allows our care team to provide patients with the most effective and progressive treatments. It’s only once these treatments are approved that they’re made available elsewhere.

Medical advances and improvements to patient care have been made possible by clinical trials and the participation of volunteers. Below are answers to frequently asked questions you may have about clinical trials.

Q. What is a clinical trial?

A. A clinical trial is a form of research that uses human volunteers (called participants) to help answer specific questions about new ways to prevent, diagnose and treat diseases. Clinical trials are extremely important because they allow researchers to work with patients suffering from the exact condition they are trying to treat.

Q. What types of clinical trials are available at Emory?

A. There are several forms of clinical trials. Some trials test new drugs, procedures or other treatments, and others look for better ways to prevent diseases in people who have either never had a disease or are trying to keep one from coming back. Some trials are used to develop better ways to diagnose a particular disease or condition while other trials help find ways to improve the care and quality of life of people with long-term illnesses.

Q. What do the different phases of trials mean?

A. Clinical trials take place in “phases,” and each phase helps researchers answer specific questions.

Phase I Clinical Trials: These trials are used to test brand new drugs, devices or procedures to find out how safe they are and identify possible side effects. They usually involve 20 to 80 people.

Phase II Clinical Trials: These trials are used to further evaluate the effectiveness and safety of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people.

Phase III Clinical Trials: These trials compare a new treatment or procedure with a standard old treatment or procedure to figure out which works best. Evaluation of side effects and effectiveness continues. They usually involve 1,000 to 8,000 people.

Phase IV Clinical Trials: Once a drug or procedure is approved by the U.S. Food and Drug Administration (FDA) and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment.

Q. Who can participate in clinical trials?

A. Both people in good health and people with certain diseases or conditions participate in clinical trials. People participate in trials to help researchers find better treatments, or to receive care or treatment only available as part of a clinical trial.

Q. How does clinical research make a difference?

A. Clinical research helps us learn about the safety and effectiveness of all drugs, procedures and other
treatments. Medical advances like new drugs and surgical procedures are made possible because of clinical trials and the voluntary participation of individuals.

At Emory, we’re conducting clinical trials and research to make a difference in people’s lives, here and now and for generations to come. While there are many benefits to participating in clinical trials, there can also be risks, which is why it is important to speak with a physician before deciding to participate. For more information on clinical trials at Emory, please view a complete list of our Frequently Asked Questions. If you have additional questions, visit our clinical trials website or call 404-778-7777.

Related Resources

Clinical Trials at Emory
Pioneering Medical Advancements
Fighting Cancer
Phase I Trials – Where All Anticancer Drugs Begin