The road of recovery from a stroke is long, arduous and full of challenges for many people. In the U.S. alone, some 590,000 people annually survive a stroke and already there are 4.8 million stroke survivors in this country.

One of the main challenges for survivors is to get the body back to performing the way it did before the stroke. Rehabilitative efforts play a key role in recovery, but often require many hours of work and involve several people in addition to the patient.

Clinical trials of a new device at Arizona State University’s Downtown Phoenix campus could help stroke survivors gain some independence and a bit of their self esteem along the way.

The clinical trial is being conducted on the “Hand Mentor,” a device invented by Kinetic Muscles Inc., Tempe. It is being tested at a new center in ASU’s College of Nursing & Healthcare Innovation. The trials will run through the middle of 2009.

Purpose of the study is to evaluate the effectiveness of the Hand Mentor, when used in conjunction with regular therapist visits and at-home physical therapy.

Linda Mottle, director of ASU’s Center for Healthcare Innovation & Clinical Trials, said a key challenge within the medical technology industry is that many new technologies like the Hand Mentor do not result in obvious gains in mortality or morbidity. That makes it important to demonstrate improvements in quality of life and economic benefits of any new invention or drug. It also is important to do so in community settings rather than just testing efficacy in carefully controlled environments.

“Some of these new interactive, patient-centered technologies coming out of laboratories can be a great boost to people who have survived a stroke or other injury,” Mottle said. “Now we need to test them in actual settings to see how effective they are in aiding recovering patients. The potential to positively impact patients’ functioning, quality of life and decrease overall costs of care is significant.”

“We are studying home use of the Hand Mentor and we want to see how it impacts rehabilitation costs of a stroke patient,” explained Ed Koeneman, founder and chief operating officer of Kinetic Muscles. “We suspect it will cost less for the patient as they try and regain hand movements by allowing much of the therapy to be done at home. It also will allow the patient to regain their independence and boost their self esteem.”

The Hand Mentor is a therapy device based on neuroplasticity, an understanding that the brain can, through certain practices, be “rewired.” For example, through memories created by repetition the brain can be taught to tell the limbs what to do, as it did before a stroke.

The Hand Mentor aids this effort by providing active repetitive motion therapy to a patient. In operation, a pneumatic muscle arm piece is strapped onto a person’s forearm and provides a coordinated motion of the hand and wrist triggered by the patient’s performance through biofeedback. This arm piece attaches to a control box, which houses the device computer and provides performance reinforcement, goal setting, clinician reports and patient feedback, Koeneman said.

The Hand Mentor simulates natural motion of the hand that has been lost due to stroke or other neurological damage. It actively involves the patient in their rehabilitation by encouraging self-initiated motion in the wrist and fingers, assisting movement only when necessary, Koeneman explained. An interactive display engages the patient and allows them to work on exercises that help them restore range of motion to their hand and wrist.

Mottle said that while the trials are on going, there still is a need for more test subjects.

“We are looking for another 20 post-stroke subjects for our trial,” she said, adding that the Nursing College’s downtown campus academic ambulatory health center is ideal for these tests.

“There’s a real need for these types of tests for new drugs, new devices, biologics and vaccines,” she explained. “That is why we are setting up collaborations with companies like Kinetic Muscles, because the outcomes of tests are fundamental to the success of these healthcare innovations.”

Mottle said these types of tests are perfect for the clinical trial center, which first opened its doors in July 2007. She added that the center includes an educational element. ASU’s College of Nursing has a graduate certificate in clinical management and it recently received approval to begin a Master of Science program for clinical research management, which will begin next fall.

While the center might only be in its early stages of development, with three clinical trials on going and six more in the pipeline she sees a bright future.

“We are small, we are new, but we’ve had huge impacts already,” Mottle said.

For more information on the Hand Mentor clinical trial and if you are interested in being part of the trials, contact Sharon Goldsworthy at (602) 496-1225.