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

Nat Commun. 2024 Feb 8;15(1):1081. doi: 10.1038/s41467-024-44791-5.

Authors

Louis N Awad^{1

2}, Arun Jayaraman³, Karen J Nolan^{4

5}, Michael D Lewek^{6

7}, Paolo Bonato⁸, Mark Newman⁹, David Putrino¹⁰, Preeti Raghavan¹¹, Ryan T Pohlig¹², Brian A Harris¹³, Danielle A Parker¹³, Sabrina R Taylor¹³

Affiliations

¹ Dept. of Physical Therapy, Boston University, Boston, MA, USA. louawad@bu.edu.
² Dept. of PM&R, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA. louawad@bu.edu.
³ Dept. of PM&R, Northwestern University, Shirley Ryan AbilityLab, Chicago, IL, USA.
⁴ Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, USA.
⁵ Dept. of PM&R, Rutgers New Jersey Medical School, Kessler Rehabilitation, Newark, NJ, USA.
⁶ Dept. of Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁷ Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Dept. of PM&R, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.
⁹ Dept. of PM&R, Carolinas Rehabilitation, Charlotte, NC, USA.
¹⁰ Abilities Research Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹¹ Depts. of PM&R & Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹² College of Health Sciences, University of Delaware, Newark, DE, USA.
¹³ MedRhythms, Inc., Portland, ME, USA.

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.

Publication types

Randomized Controlled Trial

MeSH terms

Humans
Prospective Studies
Quality of Life
Stroke Rehabilitation*
Stroke* / complications
Stroke* / therapy
Walking