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; Sabrina R. Taylor

doi:10.1038/s41467-024-44791-5

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

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, Sabrina R. Taylor

^*Corresponding author for this work

Physical Medicine and Rehabilitation

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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 (InTandem^TM) 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.

Original language	English (US)
Article number	1081
Journal	Nature communications
Volume	15
Issue number	1
DOIs	https://doi.org/10.1038/s41467-024-44791-5
State	Published - Dec 2024

Funding

We acknowledge contributions by the following study staff: at BU: Johanna Spangler, Lillian Braga-Ribeirinha, Joan Breen, Terry Ellis; at SR: Sara Prokup, Kristine Buchler, Matt Gifforn, Kelly McKenzie, Matt McGuire, Jen Traines; at KF: Melvin Mejia, Brandon Ross, Corey Greene, Kathleen Chervin, Sharon Franco, Greg Ames, Oluwaseun Ibironke; at UNC-Chapel Hill: Chelsea Duppen, Alex Huntsinger, David Rowland; at SRH: Catherine Adans-Dester, Anne O’Brien; at AH: Jillian Cummings; at JH: Kendra M. Cherry-Allen, Margaret A. French, Spencer Gonzaga. We also acknowledge the following employees at MedRhythms, Inc.: Kirsten Smayda, Ph.D. for her manuscript editing support; Jennifer Lavanture and Owen McCarthy for their work during protocol development; and Brian Bousquet-Smith, Nicholas LaJoie, and Chrissy Stack for their Clinical Operations support during the conduct of the trial. This trial was funded by MedRhythms, Inc. L.N.A. is a paid advisor to MedRhythms Inc. B.A.H. is co-founder and CEO of MedRhythms Inc. with equity interest. S.R.T. and D.A.P. are employees of MedRhythms Inc. with equity interest. This study was completed under a master management plan instituted by the Boston University Financial Conflicts of Interest Committee. The remaining authors declare no competing interests.

ASJC Scopus subject areas

General Chemistry
General Biochemistry, Genetics and Molecular Biology
General Physics and Astronomy

Access to Document

10.1038/s41467-024-44791-5

Cite this

Awad, L. N., Jayaraman, A., Nolan, K. J., Lewek, M. D., Bonato, P., Newman, M., Putrino, D., Raghavan, P., Pohlig, R. T., Harris, B. A., Parker, D. A., & Taylor, S. R. (2024). Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandem^TM. Nature communications, 15(1), Article 1081. https://doi.org/10.1038/s41467-024-44791-5

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

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.",

author = "Awad, {Louis N.} and Arun Jayaraman and Nolan, {Karen J.} and Lewek, {Michael D.} and Paolo Bonato and Mark Newman and David Putrino and Preeti Raghavan and Pohlig, {Ryan T.} and Harris, {Brian A.} and Parker, {Danielle A.} and Taylor, {Sabrina R.}",

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Awad, LN, Jayaraman, A, Nolan, KJ, Lewek, MD, Bonato, P, Newman, M, Putrino, D, Raghavan, P, Pohlig, RT, Harris, BA, Parker, DA & Taylor, SR 2024, 'Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandem^TM', Nature communications, vol. 15, no. 1, 1081. https://doi.org/10.1038/s41467-024-44791-5

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AU - Lewek, Michael D.

AU - Bonato, Paolo

AU - Newman, Mark

AU - Putrino, David

AU - Raghavan, Preeti

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AU - Harris, Brian A.

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