Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM

Louis N. Awad (), Arun Jayaraman, Karen J. Nolan, Michael D. Lewek, Paolo Bonato, Mark Newman, David Putrino, Preeti Raghavan, Ryan T. Pohlig, Brian A. Harris, Danielle A. Parker and Sabrina R. Taylor
Additional contact information
Louis N. Awad: Boston University
Arun Jayaraman: Northwestern University, Shirley Ryan AbilityLab
Karen J. Nolan: Kessler Foundation
Michael D. Lewek: University of North Carolina at Chapel Hill
Paolo Bonato: Spaulding Rehabilitation Hospital
Mark Newman: Carolinas Rehabilitation
David Putrino: Icahn School of Medicine at Mount Sinai
Preeti Raghavan: Johns Hopkins University School of Medicine
Ryan T. Pohlig: University of Delaware
Brian A. Harris: MedRhythms, Inc.
Danielle A. Parker: MedRhythms, Inc.
Sabrina R. Taylor: MedRhythms, Inc.

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract Walking slowly after stroke reduces health and quality of life. This multi-site, prospective, interventional, 2-arm randomized controlled trial (NCT04121754) evaluated the safety and efficacy of an autonomous neurorehabilitation system (InTandemTM) designed to use auditory-motor entrainment to improve post-stroke walking. 87 individuals were randomized to 5-week walking interventions with InTandem or Active Control (i.e., walking without InTandem). The primary endpoints were change in walking speed, measured by the 10-meter walk test pre-vs-post each 5-week intervention, and safety, measured as the frequency of adverse events (AEs). Clinical responder rates were also compared. The trial met its primary endpoints. InTandem was associated with a 2x larger increase in speed (Δ: 0.14 ± 0.03 m/s versus Δ: 0.06 ± 0.02 m/s, F(1,49) = 6.58, p = 0.013), 3x more responders (40% versus 13%, χ2(1) ≥ 6.47, p = 0.01), and similar safety (both groups experienced the same number of AEs). The auditory-motor intervention autonomously delivered by InTandem is safe and effective in improving walking in the chronic phase of stroke.

Date: 2024
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DOI: 10.1038/s41467-024-44791-5

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