PMID- 38332008
OWN - NLM
STAT- MEDLINE
DCOM- 20240214
LR  - 20240214
IS  - 2041-1723 (Electronic)
IS  - 2041-1723 (Linking)
VI  - 15
IP  - 1
DP  - 2024 Feb 8
TI  - Efficacy and safety of using auditory-motor entrainment to improve walking after 
      stroke: a multi-site randomized controlled trial of InTandem(TM).
PG  - 1081
LID - 10.1038/s41467-024-44791-5 [doi]
LID - 1081
AB  - 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 
      (Delta: 0.14 +/- 0.03 m/s versus Delta: 0.06 +/- 0.02 m/s, F(1,49) = 6.58, p = 0.013), 3x 
      more responders (40% versus 13%, chi(2)(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.
CI  - (c) 2024. The Author(s).
FAU - Awad, Louis N
AU  - Awad LN
AUID- ORCID: 0000-0002-0159-8011
AD  - Dept. of Physical Therapy, Boston University, Boston, MA, USA. louawad@bu.edu.
AD  - Dept. of PM&R, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, 
      MA, USA. louawad@bu.edu.
FAU - Jayaraman, Arun
AU  - Jayaraman A
AD  - Dept. of PM&R, Northwestern University, Shirley Ryan AbilityLab, Chicago, IL, 
      USA.
FAU - Nolan, Karen J
AU  - Nolan KJ
AUID- ORCID: 0000-0002-4667-0873
AD  - Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West 
      Orange, NJ, USA.
AD  - Dept. of PM&R, Rutgers New Jersey Medical School, Kessler Rehabilitation, Newark, 
      NJ, USA.
FAU - Lewek, Michael D
AU  - Lewek MD
AD  - Dept. of Health Sciences, University of North Carolina at Chapel Hill, Chapel 
      Hill, NC, USA.
AD  - Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel 
      Hill, NC, USA.
FAU - Bonato, Paolo
AU  - Bonato P
AUID- ORCID: 0000-0002-1818-1714
AD  - Dept. of PM&R, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, 
      MA, USA.
FAU - Newman, Mark
AU  - Newman M
AD  - Dept. of PM&R, Carolinas Rehabilitation, Charlotte, NC, USA.
FAU - Putrino, David
AU  - Putrino D
AUID- ORCID: 0000-0002-2232-3324
AD  - Abilities Research Center, Icahn School of Medicine at Mount Sinai, New York, NY, 
      USA.
FAU - Raghavan, Preeti
AU  - Raghavan P
AD  - Depts. of PM&R & Neurology, Johns Hopkins University School of Medicine, 
      Baltimore, MD, USA.
FAU - Pohlig, Ryan T
AU  - Pohlig RT
AD  - College of Health Sciences, University of Delaware, Newark, DE, USA.
FAU - Harris, Brian A
AU  - Harris BA
AD  - MedRhythms, Inc., Portland, ME, USA.
FAU - Parker, Danielle A
AU  - Parker DA
AD  - MedRhythms, Inc., Portland, ME, USA.
FAU - Taylor, Sabrina R
AU  - Taylor SR
AUID- ORCID: 0000-0003-4867-1922
AD  - MedRhythms, Inc., Portland, ME, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20240208
PL  - England
TA  - Nat Commun
JT  - Nature communications
JID - 101528555
SB  - IM
MH  - Humans
MH  - *Stroke Rehabilitation
MH  - Quality of Life
MH  - Prospective Studies
MH  - Walking
MH  - *Stroke/therapy/complications
PMC - PMC10853163
COIS- 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.
EDAT- 2024/02/09 00:42
MHDA- 2024/02/10 22:54
PMCR- 2024/02/08
CRDT- 2024/02/08 23:49
PHST- 2023/10/02 00:00 [received]
PHST- 2024/01/03 00:00 [accepted]
PHST- 2024/02/10 22:54 [medline]
PHST- 2024/02/09 00:42 [pubmed]
PHST- 2024/02/08 23:49 [entrez]
PHST- 2024/02/08 00:00 [pmc-release]
AID - 10.1038/s41467-024-44791-5 [pii]
AID - 44791 [pii]
AID - 10.1038/s41467-024-44791-5 [doi]
PST - epublish
SO  - Nat Commun. 2024 Feb 8;15(1):1081. doi: 10.1038/s41467-024-44791-5.