(RxWiki News) After a stroke, a person may have difficulty moving an arm or leg due to brain damage. The FDA recently approved a muscle vibration device to help stroke patients regain that movement.
Stroke can result in the paralysis of a limb on one side of the body. Stroke patients may go through intensive repetitive movement exercises that reprogram the brain so they can function better.
The FDA recently approved a robotic device designed to help individuals regain movement in an arm or leg by assisting the motion of the limb and vibrating those muscles.
"Ask your doctor about new devices for stroke patients."
Dr. Paul Cordo, PhD, a professor and neuroscientist in the Oregon Stroke Center at Oregon Health & Science University in Portland and AMES Technology, Inc., developed a muscle and joint rehabilitation medical device, which is expected to be available for use in hospitals and clinics in early 2014 because of recent FDA clearance.
The AMES rehabilitation medical device helps a patient move his or her arms or leg while delivering sensory stimulation at the same time. The machine is designed to help the brain "locate" the muscles controlling the joint, to reduce joint tightness, and to enhance sensation at the treated joint or joints. This enhanced sensation is thought to help the brain re-establish communication with the affected muscles.
The central nervous system monitors the sensory output of the muscles and, when a signal is detected, the brain senses that movement, thereby helping guide the motion.
During use, the AMES Device measures and records the patient's input effort and other parameters important in therapy. Patients may view results as real-time visual biofeedback.
The device can also perform several diagnostic tests each time a patient is treated to track progress for clinicians and insurance providers.
"Taking stroke as an example, if a person survives the initial injury, the probability is about 50 percent that he or she will never recover any functional use of the affected limb," said Dr. Cordo. "Clinicians have few options for the most severely disabled people other than working around their disabilities. How many other types of medical conditions can you think of where we give up on curing the worst affected 50 percent of the affected population? We don't think this is acceptable, so over the last 10 years, we've been working to come up with an alternative that is effective with the severely disabled, or at least able to bring them to the point that other therapies will be effective. The AMES rehabilitation device is the product of that decade of work."
Investigators say the device may also be helpful for spinal cord injury patients.
Studies conducted by Dr. Cordo and his team have provided clinical evidence that the AMES approach improves movement and strength in people with injuries to the brain and spinal cord. In some cases, the device has helped restore the ability to carry out independent activities that were previously unattainable.
The studies included treating the arm, hand and the leg. Most of the participants who were enrolled in these studies were considered to be very disabled when they started AMES treatment.
Dr. Cordo told dailyRx News about a study he and his colleagues completed testing the device with a group of 43 stroke patients who were severely impaired—23 had no visible movement in the fingers and couldn’t open their hands. Participants received thirty 30-minute treatments (a total of 15 hours) with the AMES device.
“We gave these patients treatment and after that there were significant improvements in strength and other measurements,” said Dr. Cordo. “In some patients, there was an improved ability to pick up objects and move them. A select number got to the point where they could open the hand, pick objects up, move them somewhere else and release them. They couldn’t do that at all before. It was a return of function."
Dr. Cordo added that if patients can be restored to perform daily activities and even return to work, then healthcare costs can be reduced.
The FDA granted 510(k) clearance of the AMES rehabilitation medical device on May 30. AMES is an Oregon Health & Science University spinoff company, and OHSU and Dr. Cordo have a significant financial interest in AMES Technology, Inc., a company that may have a commercial interest in the results of this research and technology.
