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

Boston University Charles River Campus

Status: Completed

Conditions: Stroke

Treatments: Device: Propulsion Neuroprosthesis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06459401

830019 (Other Grant/Funding Number)

5715

U54EB015408 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of a stroke event occurring at least 6 months ago
• Observable gait deficits
• Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
• Passive ankle dorsiflexion range of motion to neutral with the knee extended
• Ability to follow a 3-step command
• Resting heart rate between 40-100 bpm
• Resting blood pressure between 90/60 and 170/90 mmHg
• NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
• HIPAA Authorization to allow communication with healthcare provider
• Medical clearance by a physician

Exclusion criteria

• Severe aphasia or inability to communicate with investigators
• Neglect or hemianopia
• Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
• Pacemakers or similar electrical implants that could be affected by electrical stimulation
• Metal implants directly under the stimulation sites
• Pressure ulcers or skin wounds located near human-device interface sites
• More than 2 unexplained falls in the previous month

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Neuroprosthesis-Assisted Walking Evaluation

Experimental group

Description:

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.

Treatment:

Device: Propulsion Neuroprosthesis