MR-001 is a medical device providing in-home outpatient rehabilitative therapy intended to improve walking and ambulation status in adult chronic stroke patients. The device is based on Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously. RAS is a therapy supported by rigorous research of both the foundational neuroscience mechanisms and its clinical application.
The scientific principle of “auditory-motor entrainment” is the basis for the standardized clinical intervention of RAS. Studies have shown that there is rich connectivity between the auditory and motor systems via multiple cortical and subcortical networks. Specifically, it has been shown that the auditory and motor system can synchronize subconsciously to an external, auditory rhythmic cue, a phenomenon known as “auditory-motor entrainment” (also referred to as “entrainment”). The auditory rhythm provides a consistent temporal structure for synchronization between these two systems. This consistent structure is used to subconsciously inform the brain where the next movement should be.
The primary endpoint of this study will be the evaluation of the implementation of MR-001 in clinical settings, including but not limited to hospital systems, outpatient rehabilitation centers, and non-acute clinic settings. This evaluation will include detailed qualitative feedback from clinicians on suitable implementation strategies for deploying MR-001, characterization of the facilitators and barriers to delivering MR-001 to chronic stroke patients, characterization of the enrolled patient profile, and characterization of the participant experience and satisfaction with MR-001. Secondary endpoints for this study will evaluate the impact of MR-001 on walking capacity, quality of life, mood, and cognition.
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