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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University Charles River Campus
Study ID
NCT06459401
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Propulsion Neuroprosthesis — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 22, 2021
Status verified
Oct 2025
Primary completion
May 17, 2022
Completion
May 17, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neuroprosthesis-Assisted Walking Evaluation
    Participants with chronic stroke will perform a series of short overground walking evaluations at a self-selected fast walking speed with the neuroprosthesis powered and unpowered. When the neuroprosthesis is powered, it provides active neurostimulation assistance for foot clearance and propulsion. When the neuroprosthesis is unpowered, it is worn by the participant but does not provide active assistance.

Primary Outcome Measure

Immediate Change in Walking Speed [ Time Frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Neuromotor Recovery LaboratoryBostonMassachusetts02215-
Science and Engineering ComplexBostonMassachusetts02134-

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Neuromotor Recovery Laboratory· Boston, MAScience and Engineering Complex· Boston, MA

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