Robotic Rehabilitation Study Inspires Massive Follow-On at the Veterans’ Administration
By John J. Otrompke, JD
A successful study completed at Burke Medical Research Institute, results from which was published in the journal Neurorehabilitation and Neurorepair this month, inspired so much confidence in the Department of veterans’ Affairs that the VA has begun a study of robotic devices manufactured and marketed by Interactive Motion Technology (IMT) (T), testing the device in 160 patients, 70 of whom have already been recruited. The study aims to confirm results from a prior trial that found that use of the robots offers stroke patients double the benefit of using just therapists alone.
“This is a gold standard clinical trial which could form the basis for a new standard of care in evidence-based medicine for these patients,” said Dr. Albert Lo, MD, PhD, associate professor of clinical neuroscience and engineering at Brown University. Lo is also a physician at the Providence VA Medical Center, one of the sites where the trial, CSB 558, is taking place. Other centers are in Baltimore, Gainesville, Seattle and Westhaven.
The study aims to confirm the bedrock principle of neuroplasticity, on which IMT’s successful medical rehabilitation robotics program is founded. All in all, four separate robotic devices from IMT are being used. The article, “Intensive Sensory Motor Arm Training Mediated by Therapists or Robot Improves Hemiparesis in Patients with Chronic Stroke,” by Dr. Bruce T. Volpe, MD, went on-line on January 9, and will in hard copy in the print edition in March.
Numerous Ongoing Studies Illustrate Clinical Benefit
This is not the first time IMT’s commercial robots program has illustrated its beneficial application. “We’ve treated well over 300 patients with the IMT robots,” said Volpe, who is a professor of neurology and neuroscience at Cornell University Medical College, as well as a physician at Burke. Together with occupational therapist Avrielle Rykman, OT, clinical research coordinator for Burke’s robotics program, Volpe has trained as many as 50 staff from the VA at Burke in how to make the best use of the IMT robots.
Positive experiences with the IMT robots have led Volpe and Rykman to organize several other studies with the devices. In addition to the on-going VA study (for which the duo serve as clinical consultants), Burke is the home for three other clinical trials. The largest one, the ‘order effects study’ which investigates the proximal-distal relationship of the robots to the patient’s nervous system, looks at whether a clinical benefit is enjoyed if the patient is treated with a shoulder-elbow robot before the hand-wrist robot.
Seventy patients are already in the process of completing the order effects study at Burke, and another 80 have already been recruited and will be treated in 2008. “We already have all the patients recruited; one of the hardest things with any study is patient recruitment,” said Volpe.
Another IMT robot trial currently underway at Burke is a vertical study, which uses an anti-gravity robot to treat patients with subluxation, or shoulder dislocation. There are currently 30 patients in the study of the vertical robot.
Other studies look at patients who have suffered from spinal cord injuries, or even the use of IMT robots in patients who are children who suffer from cerebral palsy, such as the study just beginning now at Blythedale Hospital in Valhalla, New York, according to Avrielle Rykman.
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Compassionate Care
Robots by Interactive Motion Technologies offer promising treatments for patients who have been considered very difficult to treat in the past. The Burke spinal cord study, for example, is currently treating five patients who were previously paralyzed with IMT robots. “One of the patients was in a car accident, two were in diving accidents, and one was in a skiing accident, for example,” said Dr. Volpe, noting that the patients are between the age of 16 and their mid-40s. “We are treating the 40-year-old patient 25 years after his injury,” Volpe noted.
The patients, who have all had their spinal cords broken off around cervical five area, suffer from paraplegia and quadriparesis. “The patients have very weak arms, and we are trying to treat the muscles in the area of the broken neck, which controls the biceps and forearms. Currently, the IMT robot appears to add functional capacity in their arms,” said Volpe.
Unfortunately, some patients do not qualify for the studies, according to Avrielle Rykman. “For those patients who don’t qualify, either because they had multiple strokes, or brain bleeds, we offer a compassionate care program, in which patients are treated for 6 weeks,” she said.
And another very exciting study has begun at Blythedale Hospital, looking at the use of IMT robots in treating children who suffer from cerebral palsy. Both Avrielle Rykman and Dr. Volpe trained five staff from Blythedale, including the medical director, two physical therapists and a research technician.
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