StrokeNCT06459401
Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
A study testing Propulsion Neuroprosthesis in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Propulsion Neuroprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by electrical stimulation
- Metal implants directly under the stimulation sites
- Pressure ulcers or skin wounds located near human-device interface sites
- More than 2 unexplained falls in the previous month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Science and Engineering Complex
Boston, Massachusetts, 02134
Neuromotor Recovery Laboratory
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Propulsion Neuroprosthesis
- Keywords
- Gait Rehabilitation, Functional Electrical Stimulation (FES), Stroke, Exosuit, Propulsion, Neuroprosthesis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propulsion NeuroprosthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Propulsion Neuroprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention; Post-Intervention
Secondary outcomes (14)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention; Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start22 Feb 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants with stroke will complete study procedures that include walking with and without the intervention.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, National Institute for Biomedical Imaging and Bioengineering (NIBIB), American Heart Association
- Responsible party
- Principal investigator, Lou Awad, PT, DPT, PhD, Boston University Charles River Campus
- Investigators
- Louis Awad, PT, DPT, PhD, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459401
- Sponsor's protocol ID
- 5715
- Other IDs
- 830019, U54EB015408
- Status last verified
- Oct 2025
- First submitted
- 7 Jun 2024
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22796242Kesar 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.
PubMed 19926681Hakansson 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.
PubMed 21401663Kesar 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.
PubMed 19834018Awad 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.
PubMed 24378803Nadeau 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.
PubMed 10619100Chen 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.
PubMed 15996592Awad 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.
PubMed 31834220Bae 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.
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.
PubMed 16456121Roelker 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.
PubMed 30408710Choe 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.
PubMed 39157060
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
- ClinicalTrials.gov ID
- NCT06459401
- Acronym / sponsor ID
- 5715
- Conditions
- Stroke
- Keywords
- Gait Rehabilitation, Functional Electrical Stimulation (FES), Stroke, Exosuit, Propulsion, Neuroprosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Harvard University, National Institute for Biomedical Imaging and Bioengineering (NIBIB), American Heart Association
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants with stroke will complete study procedures that include walking with and without the intervention.
| Arm | Type | Receives |
|---|---|---|
| Neuroprosthesis-Assisted Walking Evaluation | Experimental | Device: Propulsion NeuroprosthesisParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propulsion NeuroprosthesisA 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. | Device | Neuroprosthesis-Assisted Walking Evaluation |
Primary outcome
Immediate Change in Walking Speed
Time frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
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).
Immediate Change in Paretic Propulsion
Time frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
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.
Immediate Change in Propulsion Symmetry
Time frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
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.
Immediate Change in Walking Speed
Time frame: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Paretic Propulsion
Time frame: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Propulsion Symmetry
Time frame: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Walking Speed
Time frame: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Paretic Propulsion
Time frame: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Propulsion Symmetry
Time frame: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
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.
Immediate Change in Walking Speed
Time frame: 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
Time frame: 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.
Immediate Change in Propulsion Symmetry
Time frame: 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
Time frame: 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 Non-Preferred Timing
Time frame: 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 Non-Preferred Timing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Propulsion Symmetry at Fast Speed
Time frame: 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 Comfortable Walking Speed
Time frame: Pre-Intervention; Post-Intervention
Walking speed without neurostimulation assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test.
Unassisted Paretic Propulsion at Comfortable Speed
Time frame: 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
Time frame: 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.
14 secondary outcomes
Onset Timing of Plantarflexor Neurostimulation
Time frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
Preferred Neurostimulation Timing
Time frame: Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Dorsiflexion Angle (No Dorsiflexor Impairment)
Time frame: Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Dorsiflexion Angle (With Dorsiflexor Impairment)
Time frame: Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Immediate Change in Dorsiflexion Angle
Time frame: Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Immediate Change in Plantarflexor Power
Time frame: Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Dorsiflexion Angle at Non-Preferred Timing
Time frame: Unassisted Walking Condition; Assisted Walking Condition
Plantarflexor Power at Non-Preferred Timing
Time frame: Unassisted Walking Condition; Assisted Walking Condition
Dorsiflexion Angle at Preferred Timing
Time frame: Unassisted Walking Condition; Assisted Walking Condition
Plantarflexor Power at Preferred Timing
Time frame: Unassisted Walking Condition; Assisted Walking Condition
Unassisted Dorsiflexion Angle at Fast Speed
Time frame: Pre-Intervention; Post-Intervention
Unassisted Plantarflexor Power at Fast Speed
Time frame: Pre-Intervention; Post-Intervention
Unassisted Dorsiflexion Angle at Comfortable Speed
Time frame: Pre-Intervention; Post-Intervention
Unassisted Plantarflexor Power at Comfortable Speed
Time frame: Pre-Intervention; Post-Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22796242Awad 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.
- Background: PubMed 19926681Kesar 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.
- Background: PubMed 21401663Hakansson 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.
- Background: PubMed 19834018Kesar 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.
- Background: PubMed 24378803Awad 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.
- Background: PubMed 10619100Nadeau 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.
- Background: PubMed 15996592Chen 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.
- Background: PubMed 31834220Awad 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.
- BackgroundBae 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.
- Background: PubMed 16456121Bowden 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.
- Background: PubMed 30408710Roelker 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.
- Results publication: PubMed 39157060Choe 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.
- Results ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Awad, PT, DPT, PhD study director
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propulsion Neuroprosthesis in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Change in Walking Speed (time frame: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459401, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.