MEDRhythms Inc has launched a randomized controlled trial (RCT) at five top rehab hospitals and research centers across the country to examine the impact of a digital therapeutic device on stroke survivors who have post-stroke walking impairments, in support of the company’s eventual FDA submission.

“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,” says Brian Harris, Co-Founder and CEO of Portland, Me-based MEDRhythms, in a media release. “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 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 Physica 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,” states 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.”

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, per the release.

[Source(s): MEDRhythms, Business Wire]