Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
NCT Number: NCT06459401
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Stroke
Interventions: DEVICE: Propulsion Neuroprosthesis
Sponsor: Boston University Charles River Campus
Collaborators: Harvard University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-02-22
Completion Date: 2022-05-17
Locations: Science and Engineering Complex, Boston, Massachusetts, 02134, United States|Neuromotor Recovery Laboratory, Boston, Massachusetts, 02215, United States

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.

Primary Outcome Measures: Walking Speed without neurostimulation assistance, Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test., Immediate Pre-session 10-meter walk test|Walking Speed without neurostimulation assistance, Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test., Immediate Post-session 10-meter walk test|Walking Speed without neurostimulation assistance, Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test., During session 10-meter walk test|Walking Speed with neurostimulation assistance, Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test., During session 10-meter walk test|Paretic Propulsion without neurostimulation assistance, Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb., Immediate Pre-session 10-meter walk test|Paretic Propulsion without neurostimulation assistance, Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb., Immediate Post-session 10-meter walk test|Paretic Propulsion without neurostimulation assistance, Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb., During session 10-meter walk test|Paretic Propulsion with neurostimulation assistance, Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb., During session 10-meter walk test|Propulsion Impulse without neurostimulation assistance, Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve., Immediate Pre-session 10-meter walk test|Propulsion Impulse without neurostimulation assistance, Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve., Immediate Post-session 10-meter walk test|Propulsion Impulse without neurostimulation assistance, Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve., During session 10-meter walk test|Propulsion Impulse with neurostimulation assistance, Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve., During session 10-meter walk test|Propulsion Symmetry without neurostimulation assistance, Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic)., Immediate Pre-session 10-meter walk test|Propulsion Symmetry without neurostimulation assistance, Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic)., Immediate Post-session 10-meter walk test|Propulsion Symmetry without neurostimulation assistance, Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic)., During session 10-meter walk test|Propulsion Symmetry with neurostimulation assistance, Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic)., During session 10-meter walk test
Secondary Outcome Measures: Ankle Angle without neurostimulation assistance, Ankle angle is the angle between the foot and the shank measured using optical motion capture., Immediate Pre-session 10-meter walk test|Ankle Angle without neurostimulation assistance, Ankle angle is the angle between the foot and the shank measured using optical motion capture., Immediate Post-session 10-meter walk test|Ankle Angle without neurostimulation assistance, Ankle angle is the angle between the foot and the shank measured using optical motion capture., During session 10-meter walk test|Ankle Angle with neurostimulation assistance, Ankle angle is the angle between the foot and the shank measured using optical motion capture., During session 10-meter walk test|Knee Angle without neurostimulation assistance, Knee angle is the angle between the shank and the thigh measured using optical motion capture., Immediate Pre-session 10-meter walk test|Knee Angle without neurostimulation assistance, Knee angle is the angle between the shank and the thigh measured using optical motion capture., Immediate Post-session 10-meter walk test|Knee Angle without neurostimulation assistance, Knee angle is the angle between the shank and the thigh measured using optical motion capture., During session 10-meter walk test|Knee Angle with neurostimulation assistance, Knee angle is the angle between the shank and the thigh measured using optical motion capture., During session 10-meter walk test|Ankle Moment without neurostimulation assistance, Ankle moment is the rotation force of the foot measured using optical motion capture., Immediate Pre-session 10-meter walk test|Ankle Moment without neurostimulation assistance, Ankle moment is the rotation force of the foot measured using optical motion capture., Immediate Post-session 10-meter walk test|Ankle Moment without neurostimulation assistance, Ankle moment is the rotation force of the foot measured using optical motion capture., During session 10-meter walk test|Ankle Moment with neurostimulation assistance, Ankle moment is the rotation force of the foot measured using optical motion capture., During session 10-meter walk test|Ankle Power without neurostimulation assistance, Ankle power is the rate of change in ankle moment measured using optical motion capture., Immediate Pre-session 10-meter walk test|Ankle Power without neurostimulation assistance, Ankle power is the rate of change in ankle moment measured using optical motion capture., Immediate Post-session 10-meter walk test|Ankle Power without neurostimulation assistance, Ankle power is the rate of change in ankle moment measured using optical motion capture., During session 10-meter walk test|Ankle Power with neurostimulation assistance, Ankle power is the rate of change in ankle moment measured using optical motion capture., During session 10-meter walk test