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Enrolling by Invitation

NCT Number: NCT07218094

Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke

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. 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Dynamic Motor Control Index (DMCI)

    Time frame: Assisted - Baseline

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

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

    Time frame: Assisted - Baseline

    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

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

    Time frame: Assisted - Baseline

    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

  4. Variance Accounted For (VAF) by Four Muscle Synergies

    Time frame: Assisted - Baseline

    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 (%)

  5. Paretic Propulsion

    Time frame: Assisted - Baseline

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

Secondary outcomes

  1. Joint Angle

    Time frame: Assisted - Baseline

    Difference in joint angles computed using inverse dynamics, including ankle, knee, and hip angles, with and without exosuit (degrees)

  2. Joint Torque

    Time frame: Assisted - Baseline

    Difference in joint torques computed using inverse dynamics, including ankle, knee, and hip torques, with and without exosuit (Nm/kg)

  3. Joint Power

    Time frame: Assisted - Baseline

    Difference in joint power computed using inverse dynamics, including ankle, knee, and hip power, with and without exosuit (W/kg)

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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