Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke

NCT07218094 | Enrolling By Invitation Early Phase 1 FDA Device

• 1 other identifier: 4440
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors often experience impaired neuromechanical control that limits walking speed and quality, particularly due to deficits in paretic propulsion. This study aims to identify patient-specific neuromechanical locomotor control strategies, link them to biomechanical gait impairments, and investigate how these strategies influence responses to soft robotic exosuit assistance of paretic propulsion and ground clearance during walking. The study focuses on adults who are more than six months post-stroke and have observable gait deficits. The main questions are:

1. 1.How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
2. 2.Do individuals with distinct neuromechanical patterns respond differently to robotic exosuit-assisted gait rehabilitation?

Conditions

Stroke

Keywords

Stroke; Gait Disorders, Neurologic; Gait Analysis; Neuromuscular Control; Rehabilitation, Stroke; Exoskeleton Device; Biomechanics

Outcome Measures

Primary Outcomes (5)

• Dynamic Motor Control Index (DMCI)

  Difference in neuromuscular control quality compared to normative data with and without exosuit

  Assisted - Baseline

• Correlation Between Propulsion and Weight-Acceptance Motor Modules (Temporal)

  Difference in the merging of motor module structures quantified by correlation coefficient between the propulsion temporal module and weight-acceptance temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit

  Assisted - Baseline

• Correlation Between Weight-Acceptance and Swing-Limb Deceleration Motor Modules (Temporal)

  Difference in the merging of motor module structures quantified by correlation coefficient between the weight-acceptance temporal module and swing-limb deceleration temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit

  Assisted - Baseline

• Variance Accounted For (VAF) by Four Muscle Synergies

  Difference in the variance in muscle activation accounted for by the 4-synergy model, measuring the quantitative shift in muscle coordination complexity with and without exosuit (%)

  Assisted - Baseline

• Paretic Propulsion

  Difference in anterior-posterior ground reaction force with and without exosuit (N)

  Assisted - Baseline

Secondary Outcomes (3)

• Joint Angle

  Assisted - Baseline

• Joint Torque

  Assisted - Baseline

• Joint Power

  Assisted - Baseline

Study Arms (1)

Walking without robotic ankle assistance

ACTIVE COMPARATOR

Subjects will complete a 3-minute treadmill walking trial without any intervention

Device: Walking with robotic ankle assistance

Interventions

Walking with robotic ankle assistance DEVICE

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.

Walking without robotic ankle assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• \>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.

You may not qualify if:

• Comorbidities besides stroke that impair walking (musculoskeletal, cardiovascular, pulmonary, or neurological)
• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (19)

• 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.

  PMID: 32552775 BACKGROUND

• 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.

  PMID: 25889030 BACKGROUND

• 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.

  PMID: 26721869 BACKGROUND

• 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.

  PMID: 16456121 BACKGROUND

• 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.

  PMID: 37936135 BACKGROUND

• 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.

  PMID: 33748765 BACKGROUND

• 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.

  PMID: 32229177 BACKGROUND

• 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.

  PMID: 34366824 BACKGROUND

• 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.

  PMID: 26084733 BACKGROUND

• 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.

  PMID: 23641212 BACKGROUND

• 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.

  PMID: 23830138 BACKGROUND

• 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.

  PMID: 19394023 BACKGROUND

• 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.

  PMID: 25856485 BACKGROUND

• 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.

  PMID: 37658408 BACKGROUND

• 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.

  PMID: 33087137 BACKGROUND

• 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.

  PMID: 21316240 BACKGROUND

• 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.

  PMID: 36069185 BACKGROUND

• 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.

  PMID: 37701480 BACKGROUND

• 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.

  PMID: 20007501 BACKGROUND

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will complete a 3-minute treadmill walking trial without robotic exosuit assistance and then complete two trials with different assistance profiles from which a preferred profile will be identified.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 20, 2025
• Study Start: September 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of manuscript acceptance

Locations

US (1)