Myomo yesterday released results from an investigator-led study of its MyoPro myoelectric orthotic, touting reduced upper extremity impairment with the use of the device.
Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.
The study, conducted at the Ohio State University School of Medicine, was published in the journal the Archives of Physical Medicine and Rehabilitation.
In the study, researchers examined the use of the MyoPro on 18 chronic stroke patients with moderate post-stroke upper extremity hemiparesis. Subjects were tested to evaluate the degree of impairment without the MyoPro and compare it with impairment while wearing the device.
Results from the study indicated that the use of the MyoPro orthotic significantly reduced upper extremity impairment, with changes in functionality exceeding the clinically important difference threshold of standard impairment tests.
“The results show a clinically significant instantaneous reduction in arm and hand impairment and statistically significant improvements in a range of functional tasks and significant increases in ability for feeding and drinking. The subjects showed significant decreases in time taken to grasp a cup and increased gross manual dexterity while wearing the MyoPro. These changes exceeded the FM’s clinically important difference threshold,” study authors wrote.
The company said that the trial is the 1st of several for the device, with more underway and expected publications in the future.
“What we found was across the board with these 18 subjects, when they wore the MyoPro, their outcomes, their movements, were significantly better while they were wearing the MyoPro,” Dr. Steven Page of the Ohio State University College of Medicine Stroke Center said in a press release.
“This study is an important milestone supporting Myomo’s growing commercialization efforts. It clearly demonstrates the functional value of the MyoPro orthosis and how it meets a medical necessity. It provides useful information for clinicians who recommend and prescribe the device, as well as for payers. This is the first of several clinical studies that are underway that the company expects to see published over the coming months and years,” CEO & chair Paul Gudonis said in a prepared statement.
Earlier this month, Myomo said it launched its next-generation MyoPro 2 myoelectric arm orthosis designed to restore function to paralyzed or weakened arms.
The MyoPro 2 is designed to aid patients in performing daily living activities including eating, carrying objects and general household chores, as well as enabling certain individuals to return to work. The company said that the new version improves upon previous capabilities and adds interchangeable, extended-life rechargeable batteries designed to support continuous daily use.