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...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-02-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-024-44791-5 |
| _version_ | 1797274108469182464 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Louis N. Awad |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T14:53:40Z |
| format | Article |
| id | doaj.art-90f0f2e3ed27432d8a60b585784e7dbb |
| institution | Directory Open Access Journal |
| issn | 2041-1723 |
| language | English |
| last_indexed | 2024-03-07T14:53:40Z |
| publishDate | 2024-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj.art-90f0f2e3ed27432d8a60b585784e7dbb2024-03-05T19:34:29ZengNature PortfolioNature Communications2041-17232024-02-0115111110.1038/s41467-024-44791-5Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTMLouis N. Awad0Arun Jayaraman1Karen J. Nolan2Michael D. Lewek3Paolo Bonato4Mark Newman5David Putrino6Preeti Raghavan7Ryan T. Pohlig8Brian A. Harris9Danielle A. Parker10Sabrina R. Taylor11Dept. of Physical Therapy, Boston UniversityDept. of PM&R, Northwestern University, Shirley Ryan AbilityLabCenter for Mobility and Rehabilitation Engineering, Kessler FoundationDept. of Health Sciences, University of North Carolina at Chapel HillDept. of PM&R, Harvard Medical School, Spaulding Rehabilitation HospitalDept. of PM&R, Carolinas RehabilitationAbilities Research Center, Icahn School of Medicine at Mount SinaiDepts. of PM&R & Neurology, Johns Hopkins University School of MedicineCollege of Health Sciences, University of DelawareMedRhythms, Inc.MedRhythms, Inc.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.https://doi.org/10.1038/s41467-024-44791-5 |
| spellingShingle | 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 Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM Nature Communications |
| title | Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM |
| title_full | Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM |
| title_fullStr | Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM |
| title_full_unstemmed | Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM |
| title_short | Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM |
| title_sort | efficacy and safety of using auditory motor entrainment to improve walking after stroke a multi site randomized controlled trial of intandemtm |
| url | https://doi.org/10.1038/s41467-024-44791-5 |
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