Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals 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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Propulsion Neuroprosthesis

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02134
      • Science and Engineering Complex
    • Boston, Massachusetts, United States, 02215
      • Neuromotor Recovery Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of a stroke event occurring at least 6 months ago
• Observable gait deficits
• Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
• Passive ankle dorsiflexion range of motion to neutral with the knee extended
• Ability to follow a 3-step command
• Resting heart rate between 40-100 bpm
• Resting blood pressure between 90/60 and 170/90 mmHg
• NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
• HIPAA Authorization to allow communication with healthcare provider
• Medical clearance by a physician

Exclusion Criteria:

• Severe aphasia or inability to communicate with investigators
• Neglect or hemianopia
• Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
• Pacemakers or similar electrical implants that could be affected by electrical stimulation
• Metal implants directly under the stimulation sites
• Pressure ulcers or skin wounds located near human-device interface sites
• More than 2 unexplained falls in the previous month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: American Heart Association; Harvard University; National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Study Director: Louis Awad, PT, DPT, PhD, Boston University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Results Reference

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Gait Rehabilitation; Neuroprosthesis; Propulsion; Functional Electrical Stimulation (FES); Exosuit
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 5715; U54EB015408 (U.S. NIH Grant/Contract); 830019 (Other Grant/Funding Number: American Heart Association Pre-Doctoral Fellowship Award)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No