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Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke

NCT06459401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-20

Study results available
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Summary

This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.

Conditions

Interventions

DEVICE

Propulsion Neuroprosthesis

A neuroprosthesis is a textile-based surface neurostimulation system worn on the waist and paretic lower limb that delivers neurostimulation assistance via electroconductive pads placed on the skin over the target muscles. The neuroprosthesis provides dorsiflexor stimulation during swing phase for foot clearance and plantarflexor stimulation during stance phase for propulsion, delivered synchronously based on integrated sensors detecting the wearer's gait pattern.

Sponsors & Collaborators

  • Harvard University

    collaborator OTHER

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • American Heart Association

    collaborator OTHER

  • Boston University Charles River Campus

    lead OTHER

Principal Investigators

  • Louis Awad, PT, DPT, PhD · Boston University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-05-17
Completion
2022-05-17
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06459401 on ClinicalTrials.gov