Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
- Conditions
- Stroke
- Interventions
- Device: Propulsion Neuroprosthesis
- Registration Number
- NCT06459401
- Lead Sponsor
- Boston University Charles River Campus
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neuroprosthesis-Assisted Walking Evaluation Propulsion Neuroprosthesis 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 Measures
Name Time Method Paretic Propulsion with neurostimulation assistance During session 10-meter walk test Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.
Walking Speed without neurostimulation assistance During session 10-meter walk test Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.
Propulsion Impulse without neurostimulation assistance During session 10-meter walk test Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.
Propulsion Impulse with neurostimulation assistance During session 10-meter walk test Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.
Propulsion Symmetry without neurostimulation assistance During session 10-meter walk test Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).
Propulsion Symmetry with neurostimulation assistance During session 10-meter walk test Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).
Walking Speed with neurostimulation assistance During session 10-meter walk test Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.
Paretic Propulsion without neurostimulation assistance During session 10-meter walk test Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.
- Secondary Outcome Measures
Name Time Method Ankle Power without neurostimulation assistance During session 10-meter walk test Ankle power is the rate of change in ankle moment measured using optical motion capture.
Ankle Moment without neurostimulation assistance During session 10-meter walk test Ankle moment is the rotation force of the foot measured using optical motion capture.
Ankle Angle without neurostimulation assistance During session 10-meter walk test Ankle angle is the angle between the foot and the shank measured using optical motion capture.
Ankle Angle with neurostimulation assistance During session 10-meter walk test Ankle angle is the angle between the foot and the shank measured using optical motion capture.
Knee Angle without neurostimulation assistance During session 10-meter walk test Knee angle is the angle between the shank and the thigh measured using optical motion capture.
Knee Angle with neurostimulation assistance During session 10-meter walk test Knee angle is the angle between the shank and the thigh measured using optical motion capture.
Ankle Moment with neurostimulation assistance During session 10-meter walk test Ankle moment is the rotation force of the foot measured using optical motion capture.
Ankle Power with neurostimulation assistance During session 10-meter walk test Ankle power is the rate of change in ankle moment measured using optical motion capture.
Trial Locations
- Locations (2)
Science and Engineering Complex
🇺🇸Boston, Massachusetts, United States
Neuromotor Recovery Laboratory
🇺🇸Boston, Massachusetts, United States