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This study is complete and is no longer recruiting subjects.

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Individuals who have had a stroke often experience difficulty walking within their homes and in the community. Current literature indicates that chronic walking deficits increase fall risk, reduce quality of life, and significantly lower levels of independence in stroke survivors.

Research shows that walking to an external rhythmic stimulus globally engages the brain, coupling the auditory and motor regions. For stroke survivors with damage to the motor system, this dual engagement has the effect of establishing new neural connections to the motor region. Furthermore, this has the potential to make walking certain distances, which may ordinarily be onerous or impossible tasks, achievable for these individuals. As a result of neuroplasticity, repeating these audio-cueing exercises on a consistent basis can change one¡¯s brain composition, allowing walking improvements made with the device to manifest without the engagement of the intervention.

The MedRhythms Stride Plus is an investigational device intended to help chronic stroke survivors ambulate more safely and independently within their communities by facilitating improvements in gait speed. The Stride Plus includes a patient application and sensors with commercially available headphones and smartphones. This technology uses Rhythmic Auditory Stimulation - embedded audio cues to facilitate improvements in walking speed. When using the system, patients walk with sensors that are attached to their shoes and collect gait parameters, including the following measurements: speed, stride length, symmetry (temporal and spatial), and cadence. When marketed, clinicians will be able to pre-program the device with the patient¡¯s rehabilitation goals, and the algorithm uses these endpoints and feedback from the sensors to inform changes made to the audio cues.

The purpose of this clinical study is to determine if using the Stride Plus device during gait training will result in improved walking function and quality of life. Participants will be randomized into one of two groups: one that uses the Stride Plus device during walking training, or one that performs walking training without music.

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• 50+ years old
• At least 6 months post-stroke
• Able to safely participate in 30-minute walking therapy sessions
• Not participating in another walking training study
• Does not have any hearing impairment

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Spaulding Rehabilitation Hospital

Boston University

Kessler Foundation

Mount Sinai

Johns Hopkins

Atrium Health

University of North Carolina

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MedRhythms, Inc.