Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
- Conditions
- Stroke
- 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
- Primary Outcome Measures
Name Time Method Immediate Change in Walking Speed Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Change in walking speed from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion.
Immediate Change in Paretic Propulsion Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Paretic Propulsion at Non-Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Paretic propulsion with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Immediate Change in Propulsion Symmetry Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Walking Speed at Non-Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway.
Propulsion Symmetry at Non-Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Propulsion symmetry with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Walking Speed at Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway.
Paretic Propulsion at Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Paretic propulsion with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Propulsion Symmetry at Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Propulsion symmetry with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Unassisted Fast Walking Speed Pre-Intervention; Post-Intervention Walking speed without neurostimulation assistance measured at a self-selected fast pace using the 10-Meter Walk Test.
Unassisted Paretic Propulsion at Fast Speed Pre-Intervention; Post-Intervention Paretic propulsion during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Comfortable Walking Speed Pre-Intervention; Post-Intervention Walking speed without neurostimulation assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test.
Unassisted Propulsion Symmetry at Fast Speed Pre-Intervention; Post-Intervention Propulsion symmetry during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Unassisted Paretic Propulsion at Comfortable Speed Pre-Intervention; Post-Intervention Paretic propulsion during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Propulsion Symmetry at Comfortable Speed Pre-Intervention; Post-Intervention Propulsion symmetry during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
- Secondary Outcome Measures
Name Time Method Plantarflexor Power at Non-Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Plantarflexor power with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Plantarflexor power is the peak rate of change in the rotation force of the foot towards the ground, measured using optical motion capture.
Plantarflexor Power at Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Plantarflexor power with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Plantarflexor power is the peak rate of change in the rotation force of the foot towards the ground, measured using optical motion capture.
Unassisted Dorsiflexion Angle at Fast Speed Pre-Intervention; Post-Intervention Dorsiflexion angle during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Unassisted Plantarflexor Power at Fast Speed Pre-Intervention; Post-Intervention Plantarflexor power during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Plantarflexor power is the peak rate of change in the rotation force of the foot towards the ground, measured using optical motion capture.
Unassisted Dorsiflexion Angle at Comfortable Speed Pre-Intervention; Post-Intervention Dorsiflexion angle during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Unassisted Plantarflexor Power at Comfortable Speed Pre-Intervention; Post-Intervention Plantarflexor power during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Plantarflexor power is the peak rate of change in the rotation force of the foot towards the ground, measured using optical motion capture.
Dorsiflexion Angle at Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Dorsiflexion angle with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Dorsiflexion Angle at Non-Preferred Timing Unassisted Walking Condition; Assisted Walking Condition Dorsiflexion angle with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Onset Timing of Plantarflexor Neurostimulation Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) The timepoint in the gait cycle when plantarflexor neurostimulation turns on. Early timing of plantarflexor neurostimulation was set at 40% of paretic limb support phase (before mid-stance). Late timing of plantarflexor neurostimulation was set at 60% of paretic limb support phase (after mid-stance). Actual delivery of neurostimulation may vary based on the inertial sensor based real-time control and sensing of gait features.
Preferred Neurostimulation Timing Preferred Neurostimulation Timing Condition (propulsion-based tuning) Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance).
Dorsiflexion Angle (No Dorsiflexor Impairment) Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Dorsiflexion angle during walking at a self-selected fast pace across a straight 10-meter walkway for the subset of participants without paretic dorsiflexor impairment. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Dorsiflexion Angle (With Dorsiflexor Impairment) Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Dorsiflexion angle during walking at a self-selected fast pace across a straight 10-meter walkway for the subset of participants with paretic dorsiflexor impairment. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture. Negative dorsiflexion angle indicates plantarflexion of the foot, downwards from a neutral 90-degree position.
Immediate Change in Dorsiflexion Angle Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Change in dorsiflexion angle from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Dorsiflexion angle is the positive angle between the foot and the shank from a neutral 90-degree position, measured using optical motion capture.
Immediate Change in Plantarflexor Power Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) Change in plantarflexor power from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Plantarflexor power is the peak rate of change in the rotation force of the foot towards the ground, measured using optical motion capture.
Trial Locations
- Locations (2)
Science and Engineering Complex
🇺🇸Boston, Massachusetts, United States
Neuromotor Recovery Laboratory
🇺🇸Boston, Massachusetts, United States
Science and Engineering Complex🇺🇸Boston, Massachusetts, United States