(Research Hub Theater) MR-001 Rehabilitation System: A Multi-site Randomized Controlled Trial of the Efficacy of Music-based Autonomous Rehabilitation of Gait Impairment After Stroke

Background and/or Objectives: The study aimed to evaluate the efficacy of MR-001, a novel music-based rehabilitation system based on rhythmic auditory stimulation (RAS), designed to treat gait impairments and improve walking in people with chronic stroke.

Design: Multi-site, prospective, randomized controlled trial.

Setting: Study was conducted at eight leading rehabilitation hospitals and research institutions in the United States (U.S.).

Participants: The trial included 87 adults with chronic stroke who were, on average, 8 years post stroke, 62 years old, and who had a baseline comfortable walking speed between 0.5 meters per second (m/s) and 0.8 m/s.

Interventions: MR-001 or active control (walking) for 30 minutes three times per week over a 5-week intervention period. MR-001 is a rehabilitation system that autonomously delivers an individualized and progressively challenging gait rehabilitation intervention based on RAS.

Main Outcome Measures: Improvement in gait speed (as measured by the 10-meter walk test) and conversion to community ambulator status (walking speed >0.8 m/s).

Results: The study met its primary endpoint with results that were both statistically significant and clinically relevant. MR-001-treated participants had an average increase of 22% in comfortable walking speed and 47.5% converted to community ambulator status; when compared with control, MR-001-treated participants were 3.7 times more likely to both surpass minimal clinically important difference (MCID) thresholds of walking speed increase (0.16 m/s) and convert to community ambulator status.

Conclusions: There are at least three and a half million people with chronic stroke living with gait deficits, for which there is currently no standard of care in the U.S. The results of the pivotal trial in chronic stroke suggest that MR-001 can help address this unmet need to improve walking in people with chronic stroke.