Data Published in Stroke Demonstrate Robotic Measurements of Motor Performance Can Be Used to Reduce Time and Cost of Phase III Drug Trials By 70 Percent
WATERTOWN, Mass., Feb. 24, 2014 /PRNewswire/ — Interactive Motion Technologies (IMT), global leader in Redefining Recovery™ using robotic tools for neurorehabilitation, has announced publication of results from a ground-breaking study identifying biomarkers of motor recovery in Stroke, Journal of the American Heart Association. Results of the study demonstrate that novel biomarkers of motor recovery have the potential to accelerate development of new therapeutic options for stroke patients by enabling early decision making in clinical testing, reducing required sample sizes, and offering a more reliable method to track longitudinal change in patients affected by stroke than current clinical scales.
Stroke is a leading cause of permanent disability in the United States. Every year, more than 800,000 people have a stroke. On average, one American dies from a stroke every four minutes.1 Because the population is aging and the risk of stroke more than doubles for each successive decade after the age of 55, it is anticipated that almost four percent of U.S. adults – nearly one in 25 – will have a stroke. This translates into an additional 3.4 million people with stroke in 2030. Between 2012 and 2030 total direct and in-direct stroke-related medical costs in the United States are expected to increase to $240.67 billion, an increase of 129%.2
The combination of an aging-stroke prone population, improved neurologic and medical care, and limitation of treatments for acute stroke has heightened the urgency for improved clinical trials. Despite the established networks of treatment centers, successful treatment trials for stroke require large numbers of patients, typically 600-850, largely due to variability of outcomes and assessment measurement.
Results of the 208 patient study demonstrate that Robot-Assisted Measurements of Kinematics and Kinetics (RMK2) yield objective information for an emerging archive on motor behavior after stroke and the effect of different treatments on recovery. The RMK2 assessment consists of a series of visually guided and visually evoked unconstrained reaching and circle-drawing movements and attempts to move against resistance that a patient completes over 30 minutes. Data from the study indicate robot derived models correlates very well with the Fugl-Meyer Assessment (FMA), Motor Power (MP), National Institutes of Health Stroke Scale (NIHSS), and modified Rankin Scale (mRS). Because of its predictive power, this new method, pioneered by IMT’s founder has the potential to reduce sample size and improve efficiency in clinical trials of neuroprotectants, allowing new treatment options to potentially reach patients faster.
“This study marks a novel beginning for the technology-based measurement of outcomes,” said Hermano I. Krebs, Ph.D., lead author, Principal Research Scientist and Lecturer, Newman Laboratory for Biomechanics and Human Rehabilitation, Massachusetts Institute of Technology, and founder of Interactive Motion Technologies. “It represents a proof of principle, with other robotic and wearable devices potentially affording even further efficiencies in development of therapeutic treatment options.”
InMotion Robots are an emerging class of machines designed to cooperate physically with patients that have also demonstrated significant therapeutic benefit for post stroke motor recovery of the upper extremities. InMotion robotic therapy augments each patient’s capability to learn, reacquire and improve motor skills using the brain’s own inherent neuroplasticity. The interactive robot sense the patient’s movement and responds to a patient’s continually changing ability, guiding exercise treatment accordingly. If the patient is unable to move, the robot gently assists the patient to initiate movement toward a target. If coordination is a problem, the robot “guides” the movement, allowing the patient to move towards the target using the correct motion. As the patient gains movement control, the robot provides less assistance and continually challenges the patient providing quantifiable feedback on progress and performance.
“We are very pleased to be leading the paradigm shift occurring in Physical Medicine and Rehabilitation,” said Rodolfo Rohr, Chief Executive Officer, Interactive Motion Technologies. “With the inclusion of upper extremity robot-assisted therapy in evidence based clinical guidelines from the American Heart Association and Department of Veterans Affairs robot-assisted upper extremity motor rehabilitation for post-stroke patients is an established clinical intervention. Our clinical partners have published the most substantial body of data from randomized controlled clinical trials demonstrating efficacy and cost effectiveness of InMotion robot-assisted therapy in post-stroke recovery. In addition to therapeutic benefit of upper extremity robot-assisted therapy, the ability of the InMotion Arm robot to provide objective clinical assessments of treatment progress has immense clinical impact. I am very excited with the results of this new capability of the InMotion arm robot to stream line drug clinical trials for development of new therapeutic options. This further supports our mission of improving the function and quality of life for a broad range of neurologic patients.”
About Interactive Motion Technologies
Interactive Motion Technologies (IMT) is the global pioneer and leader in providing effective robotic tools for neurorehabilitation professionals. Developed through groundbreaking medical engineering research at the Newman Laboratory for Biomechanics and Human Rehabilitation at the Massachusetts Institute of Technology (MIT), InMotion Robots have been evaluated in multiple large randomized controlled clinical trials, making them the most thoroughly researched robotic technology available in the rehabilitation industry, and are currently in use at leading medical centers worldwide. By applying the latest research in neuroscience, neurorehabilitation and biomedical engineering, IMT is redefining recovery for neurorehabilitation professionals, patients and their families. To learn more, please visit us at http://interactive-motion.com/.
1. AHA Statistical Update: Heart Disease and Stroke Statistics—2013 Update: Circulation: 2013; 127: e6-e245
2. AHA/ASA Policy Statement: Forecasting the Future of Stroke in the United States: Stroke, May 22, 2013http://stroke.ahajournals.org/content/44/8/2361
Interactive Motion Technologies
Source: PR Newswire