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

Author

Listed:
  • Louis N. Awad

    (Boston University
    Spaulding Rehabilitation Hospital)

  • Arun Jayaraman

    (Northwestern University, Shirley Ryan AbilityLab)

  • Karen J. Nolan

    (Kessler Foundation
    Kessler Rehabilitation)

  • Michael D. Lewek

    (University of North Carolina at Chapel Hill
    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.)

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.

Suggested Citation

  • 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. T, 2024. "Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM," Nature Communications, Nature, vol. 15(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-44791-5
    DOI: 10.1038/s41467-024-44791-5
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