Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke

NCT07218094 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-17

No results posted yet for this study

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. 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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Boston University Charles River Campus

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218094 on ClinicalTrials.gov