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| ID | Type | Description | Link |
|---|---|---|---|
| 830019 | Other Grant/Funding Number | American Heart Association Pre-Doctoral Fellowship Award | |
| U54EB015408 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroprosthesis-Assisted Walking Evaluation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propulsion Neuroprosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Change in Walking Speed | Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
| Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
| Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). 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. | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
| Measure | Description | Time Frame |
|---|---|---|
| Onset Timing of Plantarflexor Neurostimulation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Awad, PT, DPT, PhD | Boston University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science and Engineering Complex | Boston | Massachusetts | 02134 | United States | ||
| Neuromotor Recovery Laboratory |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22796242 | Background | Awad LN, Kesar TM, Reisman D, Binder-Macleod SA. Effects of repeated treadmill testing and electrical stimulation on post-stroke gait kinematics. Gait Posture. 2013 Jan;37(1):67-71. doi: 10.1016/j.gaitpost.2012.06.001. Epub 2012 Jul 15. | |
| 19926681 | Background | Kesar TM, Perumal R, Jancosko A, Reisman DS, Rudolph KS, Higginson JS, Binder-Macleod SA. Novel patterns of functional electrical stimulation have an immediate effect on dorsiflexor muscle function during gait for people poststroke. Phys Ther. 2010 Jan;90(1):55-66. doi: 10.2522/ptj.20090140. Epub 2009 Nov 19. |
| Label | URL |
|---|---|
| Results Reference | View source |
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Participants with chronic (> 6 months) stroke were screened from a participant pool known to the Boston University Neuromotor Recovery Laboratory. Of the 18 participants screened, 13 participants were eligible for enrollment, and 10 participants completed the study. Exclusions: pacemaker (1), live far away / unwilling to travel (1), joint replacement (1), ankle dorsiflexion less than neutral (2), unable to be contacted (1), medical complications preventing participation (1), not interested (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuroprosthesis-Assisted Walking Evaluation | 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. The propulsion neuroprosthesis is a textile-based 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuroprosthesis-Assisted Walking Evaluation | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immediate Change in Walking Speed | Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). | Posted | Mean | Standard Error | meters per second (m/s) | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuroprosthesis-Assisted Walking Evaluation | 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. The propulsion neuroprosthesis is a textile-based 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. |
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Data streaming issue led to two participants not having information about the timing of neurostimulation assistance during the gait cycle.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashlyn Aiello | Boston University | 617-500-3645 | ajma@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2021 | Apr 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2024 | Apr 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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All participants with stroke will complete study procedures that include walking with and without the intervention.
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|
| Immediate Change in Walking Speed |
Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. |
| Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). 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. | Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). 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. | Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Walking Speed | Change in walking speed from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance). 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. | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). 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. | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Walking Speed | 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. | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Paretic Propulsion | 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. | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Propulsion Symmetry | 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. | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Walking Speed at Non-Preferred Timing | Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. | Unassisted Walking Condition; Assisted Walking Condition |
| Paretic Propulsion at Non-Preferred Timing | 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. | Unassisted Walking Condition; Assisted Walking Condition |
| Propulsion Symmetry at Non-Preferred Timing | 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 Walking Condition; Assisted Walking Condition |
| Walking Speed at Preferred Timing | Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. | Unassisted Walking Condition; Assisted Walking Condition |
| Paretic Propulsion at Preferred Timing | 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. | Unassisted Walking Condition; Assisted Walking Condition |
| Propulsion Symmetry at Preferred Timing | 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 Walking Condition; Assisted Walking Condition |
| Unassisted Fast Walking Speed | Walking speed without neurostimulation assistance measured at a self-selected fast pace using the 10-Meter Walk Test. | Pre-Intervention; Post-Intervention |
| Unassisted Paretic Propulsion at Fast Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Propulsion Symmetry at Fast Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Comfortable Walking Speed | Walking speed without neurostimulation assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test. | Pre-Intervention; Post-Intervention |
| Unassisted Paretic Propulsion at Comfortable Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Propulsion Symmetry at Comfortable Speed | 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. | Pre-Intervention; Post-Intervention |
| Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
| Preferred Neurostimulation Timing | 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). | Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Dorsiflexion Angle (No Dorsiflexor Impairment) | 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. | Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Dorsiflexion Angle (With Dorsiflexor Impairment) | 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. | Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Dorsiflexion Angle | 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. | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Immediate Change in Plantarflexor Power | 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. | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
| Dorsiflexion Angle at Non-Preferred Timing | 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. | Unassisted Walking Condition; Assisted Walking Condition |
| Plantarflexor Power at Non-Preferred Timing | 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 Walking Condition; Assisted Walking Condition |
| Dorsiflexion Angle at Preferred Timing | 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. | Unassisted Walking Condition; Assisted Walking Condition |
| Plantarflexor Power at Preferred Timing | 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 Walking Condition; Assisted Walking Condition |
| Unassisted Dorsiflexion Angle at Fast Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Plantarflexor Power at Fast Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Dorsiflexion Angle at Comfortable Speed | 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. | Pre-Intervention; Post-Intervention |
| Unassisted Plantarflexor Power at Comfortable Speed | 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. | Pre-Intervention; Post-Intervention |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| 21401663 | Background | Hakansson NA, Kesar T, Reisman D, Binder-Macleod S, Higginson JS. Effects of fast functional electrical stimulation gait training on mechanical recovery in poststroke gait. Artif Organs. 2011 Mar;35(3):217-20. doi: 10.1111/j.1525-1594.2011.01215.x. |
| 19834018 | Background | Kesar TM, Perumal R, Reisman DS, Jancosko A, Rudolph KS, Higginson JS, Binder-Macleod SA. Functional electrical stimulation of ankle plantarflexor and dorsiflexor muscles: effects on poststroke gait. Stroke. 2009 Dec;40(12):3821-7. doi: 10.1161/STROKEAHA.109.560375. Epub 2009 Oct 15. |
| 24378803 | Background | Awad LN, Reisman DS, Kesar TM, Binder-Macleod SA. Targeting paretic propulsion to improve poststroke walking function: a preliminary study. Arch Phys Med Rehabil. 2014 May;95(5):840-8. doi: 10.1016/j.apmr.2013.12.012. Epub 2013 Dec 28. |
| 10619100 | Background | Nadeau S, Gravel D, Arsenault AB, Bourbonnais D. Plantarflexor weakness as a limiting factor of gait speed in stroke subjects and the compensating role of hip flexors. Clin Biomech (Bristol). 1999 Feb;14(2):125-35. doi: 10.1016/s0268-0033(98)00062-x. |
| 15996592 | Background | Chen G, Patten C, Kothari DH, Zajac FE. Gait differences between individuals with post-stroke hemiparesis and non-disabled controls at matched speeds. Gait Posture. 2005 Aug;22(1):51-6. doi: 10.1016/j.gaitpost.2004.06.009. |
| 31834220 | Background | Awad LN, Hsiao H, Binder-Macleod SA. Central Drive to the Paretic Ankle Plantarflexors Affects the Relationship Between Propulsion and Walking Speed After Stroke. J Neurol Phys Ther. 2020 Jan;44(1):42-48. doi: 10.1097/NPT.0000000000000299. |
| Background | Bae J, Siviy C, Rouleau M, Menard N, O'Donnell K, Galiana I, Athanassiu M, Ryan D, Bibeau C, Sloot L, Kudzia P, Ellis T, Awad L, Walsh CJ. A lightweight and efficient portable soft exosuit for particular ankle assistance in walking after stroke. IEEE International Conference on Robotics and Automation (ICRA). 2018; 2820-2827. |
| 16456121 | Background | Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2. |
| 30408710 | Background | Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25. |
| 39157060 | Result | Choe DK, Aiello AJ, Spangler JE, Walsh CJ, Awad LN. A Propulsion Neuroprosthesis Improves Overground Walking in Community-Dwelling Individuals After Stroke. IEEE Open J Eng Med Biol. 2024 Jul 4;5:563-572. doi: 10.1109/OJEMB.2024.3416028. eCollection 2024. |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Paretic Side | Side of body most affected by the stroke. | Count of Participants | Participants |
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| Stroke Chronicity | Length of time since onset of stroke, assessed at study start. | Mean | Standard Deviation | years |
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| Height | Mean | Standard Deviation | centimeters (cm) |
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| Weight | Mean | Standard Deviation | kilograms (kg) |
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| Comfortable Walking Speed | Speed of self-selected comfortable walking pace measured during the 10-Meter Walk Test (10mWT), a clinical assessment of walking speed. | Mean | Standard Deviation | meters per second (m/s) |
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| Fast Walking Speed | Speed of self-selected fast walking pace measured during the 10-Meter Walk Test (10mWT), a clinical assessment of walking speed. | Mean | Standard Deviation | meters per second (m/s) |
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| Paretic Propulsion | Peak anterior-posterior ground reaction force of the paretic limb, measured at a self-selected comfortable pace during the 10-Meter Walk Test. | Mean | Standard Deviation | percent bodyweight (%bw) |
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| Propulsion Symmetry | The contribution of the paretic limb to the total propulsion impulse (i.e., propulsion impulse of the paretic limb divided by the total propulsion impulse, paretic + nonparetic), measured at a self-selected comfortable pace during the 10-Meter Walk Test. Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve. | Mean | Standard Deviation | percent (%) |
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| Dorsiflexion Angle | Peak ankle angle during swing phase, measured at a self-selected comfortable pace during the 10-Meter Walk Test. | Mean | Standard Deviation | degrees |
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| Dorsiflexor Impairment | Number of participants with paretic dorsiflexion angle during swing phase that is less than neutral (90-degree angle between foot and shank). | Count of Participants | Participants |
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| Primary | Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
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| Primary | Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. 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). 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. | Posted | Mean | Standard Error | percent (%) | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
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| Primary | Immediate Change in Walking Speed | Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. | Posted | Mean | Standard Error | meters per second (m/s) | Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). 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. | Posted | Mean | Standard Error | percent (%) | Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Walking Speed | Change in walking speed from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. | Posted | Mean | Standard Error | meters per second (m/s) | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Paretic Propulsion | Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance). 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Propulsion Symmetry | Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). 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. | Posted | Mean | Standard Error | percent (%) | Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Walking Speed | 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. | Posted | Mean | Standard Error | meters per second (m/s) | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Paretic Propulsion | 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Immediate Change in Propulsion Symmetry | 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. | Posted | Mean | Standard Error | percent (%) | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Primary | Walking Speed at Non-Preferred Timing | Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. | Posted | Mean | Standard Error | meters per second (m/s) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Paretic Propulsion at Non-Preferred Timing | 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Propulsion Symmetry at Non-Preferred Timing | 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. | Posted | Mean | Standard Error | percent (%) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Walking Speed at Preferred Timing | Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. | Posted | Mean | Standard Error | meters per second (m/s) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Paretic Propulsion at Preferred Timing | 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Propulsion Symmetry at Preferred Timing | 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. | Posted | Mean | Standard Error | percent (%) | Unassisted Walking Condition; Assisted Walking Condition |
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| Primary | Unassisted Fast Walking Speed | Walking speed without neurostimulation assistance measured at a self-selected fast pace using the 10-Meter Walk Test. | Posted | Mean | Standard Error | meters per second (m/s) | Pre-Intervention; Post-Intervention |
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| Primary | Unassisted Paretic Propulsion at Fast Speed | 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Pre-Intervention; Post-Intervention |
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| Primary | Unassisted Propulsion Symmetry at Fast Speed | 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. | Posted | Mean | Standard Error | percent (%) | Pre-Intervention; Post-Intervention |
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| Primary | Unassisted Comfortable Walking Speed | Walking speed without neurostimulation assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test. | Posted | Mean | Standard Error | meters per second (m/s) | Pre-Intervention; Post-Intervention |
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| Primary | Unassisted Paretic Propulsion at Comfortable Speed | 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. | Posted | Mean | Standard Error | percent bodyweight (%bw) | Pre-Intervention; Post-Intervention |
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| Primary | Unassisted Propulsion Symmetry at Comfortable Speed | 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. | Posted | Mean | Standard Error | percent (%) | Pre-Intervention; Post-Intervention |
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| Secondary | Onset Timing of Plantarflexor Neurostimulation | 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. | Neurostimulation timing information was not available for 2 participants due to issues with data streaming from the neuroprosthesis. | Posted | Mean | Standard Deviation | percent stance (% stance) | Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance) |
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| Secondary | Preferred Neurostimulation Timing | 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). | Posted | Count of Participants | Participants | Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Secondary | Dorsiflexion Angle (No Dorsiflexor Impairment) | 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. | Posted | Mean | Standard Deviation | degrees | Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Secondary | Dorsiflexion Angle (With Dorsiflexor Impairment) | 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. | Posted | Mean | Standard Deviation | degrees | Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Secondary | Immediate Change in Dorsiflexion Angle | 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. | Posted | Mean | Standard Error | degrees | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Secondary | Immediate Change in Plantarflexor Power | 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. | Posted | Mean | Standard Error | watt per kilogram (W/kg) | Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning) |
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| Secondary | Dorsiflexion Angle at Non-Preferred Timing | 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. | Posted | Mean | Standard Error | degrees | Unassisted Walking Condition; Assisted Walking Condition |
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| Secondary | Plantarflexor Power at Non-Preferred Timing | 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. | Posted | Mean | Standard Error | watts per kilogram (W/kg) | Unassisted Walking Condition; Assisted Walking Condition |
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| Secondary | Dorsiflexion Angle at Preferred Timing | 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. | Posted | Mean | Standard Error | degrees | Unassisted Walking Condition; Assisted Walking Condition |
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| Secondary | Plantarflexor Power at Preferred Timing | 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. | Posted | Mean | Standard Error | watts per kilogram (W/kg) | Unassisted Walking Condition; Assisted Walking Condition |
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| Secondary | Unassisted Dorsiflexion Angle at Fast Speed | 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. | Posted | Mean | Standard Error | degrees | Pre-Intervention; Post-Intervention |
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| Secondary | Unassisted Plantarflexor Power at Fast Speed | 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. | Posted | Mean | Standard Error | watt per kilogram (W/kg) | Pre-Intervention; Post-Intervention |
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| Secondary | Unassisted Dorsiflexion Angle at Comfortable Speed | 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. | Posted | Mean | Standard Error | degrees | Pre-Intervention; Post-Intervention |
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| Secondary | Unassisted Plantarflexor Power at Comfortable Speed | 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. | Posted | Mean | Standard Error | watt per kilogram (W/kg) | Pre-Intervention; Post-Intervention |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
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Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.
Single group test of difference.