MedRhythms, a US-based digital therapeutics company, has launched its five-site randomised controlled trial (RCT) at rehabilitation hospitals and research centres to examine a post-stroke walking rehabilitation device.

This is the first product in the company’s pipeline of digital therapeutics.

This RCT will study the product’s effect on walking among a group of patients who are stroke survivors and have post-stroke walking impairments.

It is estimated that 3.5 million people in the US live with walking deficits due to chronic stroke, and this number will rise by 465,000 individuals every year.

MedRhythms aims to address this unmet medical need by developing the therapeutic.

MedRhythms co-founder and CEO Brian Harris said: “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.

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“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.”

The clinical trial will be carried out at 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 study is being launched after completing a feasibility study in the target population, which took place at the Boston University Neuromotor Recovery Lab.

The company will announce the results of the feasibility study at the American Physical Therapy Association’s annual Combined Sections Meeting in February 2020 in Denver, Colorado.

MedRhythms’ Mount Sinai clinical trial site principal investigator David Putrino said: “Right now, the MedRhythms digital therapeutic technology is a novel treatment for a subset of individuals that have few, if any, effective treatment options.

“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.”