NCT06459401

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston University Charles River Campus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Ten individuals with chronic post-stroke hemiparesis will complete a single session of walking with and without the neuroprosthesis. Study evaluations will be conducted both before and after the session, without the neuroprosthesis active, and during the neuroprosthesis-supported walking.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-22
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2024-06-14
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study