Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
NCT ID: NCT07218094
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
EARLY_PHASE1
22 participants
INTERVENTIONAL
2025-09-11
2026-02-28
Brief Summary
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The main questions are:
1. How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
2. Do individuals with distinct neuromechanical patterns respond differently to robotic exosuit-assisted gait rehabilitation?
Researchers will compare walking performance without and with robotic exosuit assistance to determine whether tailoring exosuit-assisted gait intervention to patient-specific neuromechanical profiles can lead to greater improvements in walking function. Participants will complete treadmill and overground walking assessments instrumented with motion capture, EMG, and force plates, performing one trial without assistance and two trials with robotic exosuit assistance delivered at different assistance onset timings, from which a preferred assistance setting will be identified. The walking trial associated with the preferred assistance setting will be used for primary analyses.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Walking without robotic ankle assistance
Subjects will complete a 3-minute treadmill walking trial without any intervention
Walking with robotic ankle assistance
Subjects will complete two trials of 3-minute treadmill walking with active robotic exosuit assistance, from which a preferred assistance profile will be identified. The treadmill walk associated with the preferred profile will be used for primary analyses.
Interventions
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Walking with robotic ankle assistance
Subjects will complete two trials of 3-minute treadmill walking with active robotic exosuit assistance, from which a preferred assistance profile will be identified. The treadmill walk associated with the preferred profile will be used for primary analyses.
Eligibility Criteria
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Inclusion Criteria
* \>6 months post-stroke
* Observable gait deficits
* Able to walk overground and on a treadmill without body-weight support
* Able to communicate clearly with investigators and follow instructions
* Able to fit the exosuit components, including height between 4'8" and 6'7", weight \< 264lbs, neutral ankle dorsiflexion during standing.
Exclusion Criteria
* Severe pain, neglect, hemianopia, or aphasia limiting comprehension
* Unexplained dizziness or more than 2 falls in the previous month
* Inability to communicate (as assessed by a licensed physical therapist)
* Inability to wear the exosuit due to conditions that require medical management, such as open wounds or broken skin, or as assessed by a licensed physical therapist.
18 Years
ALL
No
Sponsors
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Boston University Charles River Campus
OTHER
Responsible Party
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Lou Awad, PT, DPT, PhD
Associate Professor
Locations
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Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, United States
Countries
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References
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Awad LN, Esquenazi A, Francisco GE, Nolan KJ, Jayaraman A. The ReWalk ReStore soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation. J Neuroeng Rehabil. 2020 Jun 18;17(1):80. doi: 10.1186/s12984-020-00702-5.
Farris DJ, Hampton A, Lewek MD, Sawicki GS. Revisiting the mechanics and energetics of walking in individuals with chronic hemiparesis following stroke: from individual limbs to lower limb joints. J Neuroeng Rehabil. 2015 Feb 27;12:24. doi: 10.1186/s12984-015-0012-x.
Hsiao H, Awad LN, Palmer JA, Higginson JS, Binder-Macleod SA. Contribution of Paretic and Nonparetic Limb Peak Propulsive Forces to Changes in Walking Speed in Individuals Poststroke. Neurorehabil Neural Repair. 2016 Sep;30(8):743-52. doi: 10.1177/1545968315624780. Epub 2015 Dec 31.
Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.
Porciuncula F, Arumukhom Revi D, Baker TC, Sloutsky R, Walsh CJ, Ellis TD, Awad LN. Effects of high-intensity gait training with and without soft robotic exosuits in people post-stroke: a development-of-concept pilot crossover trial. J Neuroeng Rehabil. 2023 Nov 7;20(1):148. doi: 10.1186/s12984-023-01267-9.
Awad LN, Kudzia P, Revi DA, Ellis TD, Walsh CJ. Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. IEEE Open J Eng Med Biol. 2020;1:108-115. doi: 10.1109/ojemb.2020.2984429. Epub 2020 Apr 2.
Moucheboeuf G, Griffier R, Gasq D, Glize B, Bouyer L, Dehail P, Cassoudesalle H. Effects of robotic gait training after stroke: A meta-analysis. Ann Phys Rehabil Med. 2020 Nov;63(6):518-534. doi: 10.1016/j.rehab.2020.02.008. Epub 2020 Mar 27.
Collimore AN, Aiello AJ, Pohlig RT, Awad LN. The Dynamic Motor Control Index as a Marker of Age-Related Neuromuscular Impairment. Front Aging Neurosci. 2021 Jul 22;13:678525. doi: 10.3389/fnagi.2021.678525. eCollection 2021.
Steele KM, Rozumalski A, Schwartz MH. Muscle synergies and complexity of neuromuscular control during gait in cerebral palsy. Dev Med Child Neurol. 2015 Dec;57(12):1176-82. doi: 10.1111/dmcn.12826. Epub 2015 Jun 17.
Bizzi E, Cheung VC. The neural origin of muscle synergies. Front Comput Neurosci. 2013 Apr 29;7:51. doi: 10.3389/fncom.2013.00051. eCollection 2013.
Allen JL, Kautz SA, Neptune RR. The influence of merged muscle excitation modules on post-stroke hemiparetic walking performance. Clin Biomech (Bristol). 2013 Jul;28(6):697-704. doi: 10.1016/j.clinbiomech.2013.06.003. Epub 2013 Jul 2.
Neptune RR, Clark DJ, Kautz SA. Modular control of human walking: a simulation study. J Biomech. 2009 Jun 19;42(9):1282-7. doi: 10.1016/j.jbiomech.2009.03.009. Epub 2009 Apr 25.
Ting LH, Chiel HJ, Trumbower RD, Allen JL, McKay JL, Hackney ME, Kesar TM. Neuromechanical principles underlying movement modularity and their implications for rehabilitation. Neuron. 2015 Apr 8;86(1):38-54. doi: 10.1016/j.neuron.2015.02.042.
Sloot LH, Baker LM, Bae J, Porciuncula F, Clement BF, Siviy C, Nuckols RW, Baker T, Sloutsky R, Choe DK, O'Donnell K, Ellis TD, Awad LN, Walsh CJ. Effects of a soft robotic exosuit on the quality and speed of overground walking depends on walking ability after stroke. J Neuroeng Rehabil. 2023 Sep 1;20(1):113. doi: 10.1186/s12984-023-01231-7.
Awad LN, Lewek MD, Kesar TM, Franz JR, Bowden MG. These legs were made for propulsion: advancing the diagnosis and treatment of post-stroke propulsion deficits. J Neuroeng Rehabil. 2020 Oct 21;17(1):139. doi: 10.1186/s12984-020-00747-6.
Allen JL, Kautz SA, Neptune RR. Step length asymmetry is representative of compensatory mechanisms used in post-stroke hemiparetic walking. Gait Posture. 2011 Apr;33(4):538-43. doi: 10.1016/j.gaitpost.2011.01.004. Epub 2011 Feb 11.
Moore SA, Boyne P, Fulk G, Verheyden G, Fini NA. Walk the Talk: Current Evidence for Walking Recovery After Stroke, Future Pathways and a Mission for Research and Clinical Practice. Stroke. 2022 Nov;53(11):3494-3505. doi: 10.1161/STROKEAHA.122.038956. Epub 2022 Sep 7.
Kesar T. The Effects of Stroke and Stroke Gait Rehabilitation on Behavioral and Neurophysiological Outcomes:: Challenges and Opportunities for Future Research. Dela J Public Health. 2023 Aug 31;9(3):76-81. doi: 10.32481/djph.2023.08.013. eCollection 2023 Aug.
Clark DJ, Ting LH, Zajac FE, Neptune RR, Kautz SA. Merging of healthy motor modules predicts reduced locomotor performance and muscle coordination complexity post-stroke. J Neurophysiol. 2010 Feb;103(2):844-57. doi: 10.1152/jn.00825.2009. Epub 2009 Dec 9.
Other Identifiers
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4440
Identifier Type: -
Identifier Source: org_study_id
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