MedRhythms, Inc., a Portland, Maine-based digital therapeutics company, today announced the launch of its 5-site randomized controlled trial (RCT) at the nation’s top rehabilitation hospitals and research centers to study a device that is the first product in the Company’s pipeline of digital therapeutics for neurologic disease and injury. This RCT will examine the product’s impact on walking among a group of subjects who are stroke survivors with post-stroke walking impairments.
There are an estimated 3.5 million people in the US who live with walking deficits caused by chronic stroke, and this number rises by 465,000 individuals annually. Walking deficits profoundly impact independence and quality of life in this underserved population, which currently has limited walking rehabilitation solutions. MedRhythms seeks to address a significant unmet medical need by developing this therapeutic that has the potential to impact the lives of millions.
“This clinical trial marks an important milestone toward MedRhythms’ mission to make this high-quality intervention available to those who need and deserve to have it,” said Brian Harris, Co-Founder and CEO of MedRhythms. “As this new industry grows, it is important for digital therapeutics to demonstrate efficacy with the support of rigorous clinical trials, and this RCT is an integral step in MedRhythms’ evidence generation strategy to do so.”
MedRhythms’ clinical trial will be conducted at the nation’s top rehabilitation hospitals and research centers. These sites include: the Shirley Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey, Mt. Sinai Hospital in New York, Spaulding Rehabilitation Hospital in Boston, and the Boston University Neuromotor Recovery Laboratory in Boston. This trial was launched following completion of a successful feasibility study in the target population, which was conducted at the Boston University Neuromotor Recovery Lab. The results of this feasibility study will be announced at the American Physical Therapy Association’s annual Combined Sections Meeting in February 2020 in Denver, Colorado.
“Right now, the MedRhythms digital therapeutic technology is a novel treatment for a subset of individuals that have few, if any, effective treatment options,” said David Putrino, the Director of Abilities Research Center (ARC) for the Department of Rehabilitation and Human Performance at the Mount Sinai Health System and the Principal Investigator at MedRhythms’ Mount Sinai clinical trial site. “The mission of the ARC is to identify and validate novel technologies that have the potential to significantly enhance the rehabilitation of people who are recovering from brain injuries and neurological conditions, including chronic stroke. The digital therapeutics industry has the potential to transform rehabilitation and disrupt healthcare, and it is imperative for companies in this space to run full-scale, multisite RCTs like MedRhythms is doing.”
Earlier this year, MedRhythms announced the creation of a Stroke Scientific Advisory Board that includes Dr. Lou Awad, Dr. Randi Black-Schaffer, and Dr. Magdy H. Selim. Click here for the full press release.
The digital therapeutic for post-stroke walking rehabilitation is one of a full pipeline of products that include therapeutics for indications such as Parkinson’s Disease, Multiple Sclerosis, Aging, and Fall Prevention, for which the company is actively exploring partnerships. MedRhythms is dedicated to developing products that use a direct mechanism of action, meaning that each therapeutic is designed to target specific neural pathways in each population.