MedRhythms Announces Key Publications Confirming Efficacy, Safety, and Usability of InTandem™ for Chronic Stroke Walking Impairment

• Multi-center randomized controlled trial achieved primary endpoint: Use of InTandem resulted in a clinically-meaningful and statistically-significant increase in walking speed.
• Participants randomized to InTandem were three times more likely to be responders as compared to an active control.
• Safe and effective home-use was confirmed in a summative usability study.

PORTLAND, Maine, Feb. 8, 2024 /PRNewswire/ -- MedRhythms announced today publication of two studies validating the efficacy, safety, and usability of InTandem™, a FDA-authorized, prescription-only neurorehabilitation system for home use to improve walking and ambulation in adults with chronic stroke. Results of the multi-site randomized controlled trial demonstrated the clinical benefits and safety of InTandem, and were published in Nature Communications. The summative usability study, results of which were published in JMIR Rehabilitation and Assistive Technologies, confirmed the safe and effective use of InTandem by people with chronic stroke in the home environment.

Stroke-induced impairments in neuromotor control contribute to the characteristically slow, asymmetrical and metabolically expensive gait of people post-stroke. Slow and asymmetrical walking is associated with a high fall risk, increased comorbidities, and reduced quality of life. Historically, there has been a key care gap in the availability of efficacious walking rehabilitation interventions for the chronic phase of stroke recovery, typically defined as six or more months after the initial stroke.

"Walking speed is widely thought of as the functional vital sign; slow walking is associated with reduced health and quality of life," said Dr. Lou Awad, founding director of Boston University's Neuromotor Recovery Lab in the Sargent College of Health & Rehabilitation Sciences, and PI of the randomized controlled trial. "But faster walking can sometimes come at the cost of gait quality. There are few interventions that can help people with chronic stroke gait impairment improve both their gait speed and quality. InTandem's use of auditory-motor entrainment to deliver an individualized gait intervention has shown a remarkable ability to improve walking speed, reduce gait asymmetry, and make walking after stroke ultimately less effortful and more stable."

In the randomized controlled trial, study participants with chronic stroke were randomly assignd to InTandem or an active control group. Both groups were asked to complete three, thirty-minute walking sessions each week for five weeks. The study found the following results:

• Trial participants randomized to InTandem demonstrated statistically significant increases in walking speed (?: 0.14±0.03 m/s) as compared to an Active Control (?: 0.06±0.02 m/s) (F(1,49)=6.58, p=0.013).
• InTandem users were over three times more likely to be classified as responders which required a walking speed increase >0.16m/s combined with a walking speed of = 0.8 m/s.
• 48% of InTandem users converted from limited ambulators to community ambulators (> 0.8 m/s).
• Data further confirmed that InTandem was safe.

Eight of the top rehabilitation hospitals and research institutions in the U.S. participated in the trial: Shirley Ryan AbilityLab, Spaulding Rehabilitation, the Boston University Neuromotor Recovery Laboratory, Kessler Foundation, Mount Sinai Health System, Atrium Health, the University of North Carolina at Chapel Hill, and Johns Hopkins University.

"Stroke can significantly impact a person's ability to walk, putting them at greater risk for falls, other health conditions and poorer quality of life," said Paolo Bonato, PhD, director of the Motion Analysis Lab at Spaulding Rehabilitation. "Our trial shows that an intervention applying algorithmically-controlled music as a rhythmic stimulus improves walking and ambulation by inciting and harnessing the unconscious synchronization of the auditory and motor systems."

In addition to the randomized controlled trial, results of a summative usability of InTandem were recently published in JMIR Rehabilitation and Assistive Technologies and found that 93% of adult chronic stroke participants could complete the tasks associated with using InTandem in a home environment. No adverse events, including slips, trips, or falls, occurred in the study.

"This cumulative evidence is an important step forward in our mission to improve health outcomes for stroke survivors. These results confirm InTandem's safety and efficacy for home use by patients living with gait impairment in the chronic stroke recovery phase. This evidence forms the most critical foundation for making a meaningful impact on patients' everyday lives," said Brian Harris, MedRhythms CEO and Co-Founder. 

To learn more about the research behind InTandem and how MedRhythms harnesses clinical applications of neuroscience to develop a novel neurorehabilitation system for chronic stroke, visit intandemrx.com

Meet the MedRhythms team and learn more about the full InTandem results at these upcoming events:

• Association of VA Neurology Services (AVANS) Inaugural Meeting on February 10, 2024
• American Physical Therapy Association (APTA) Combined Sections Meeting on February 15-17, 2024.
• Association of Academic Physiatrists (AAP) Annual Meeting on February 20-24, 2024

InTandem Indication and Intended Use
InTandem is indicated to improve walking and ambulation in chronic stroke, and is intended to be used in the home for the physical rehabilitation of ambulatory adults. For full prescriber information, including important safety information and Instructions for Use (IFU) visit: www.intandemrx.com

About MedRhythms
MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of products across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease.  In 2021, the company partnered with Universal Music Group and raised a Series B financing round led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine.

Contact: [email protected]

For more information, visit www.medrhythms.com.

MedRhythms and InTandem are trademarks of MedRhythms, Inc.

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