Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke

NCT06459401 | Completed Results FDA Device

• 3 other identifiers: 5715830019U54EB015408
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.

Conditions

Stroke

Keywords

Gait Rehabilitation; Functional Electrical Stimulation (FES); Stroke; Exosuit; Propulsion; Neuroprosthesis

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (14)

• Onset Timing of Plantarflexor Neurostimulation

  Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)

• Preferred Neurostimulation Timing

  Preferred Neurostimulation Timing Condition (propulsion-based tuning)

• Dorsiflexion Angle (No Dorsiflexor Impairment)

  Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)

• Dorsiflexion Angle (With Dorsiflexor Impairment)

  Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)

• Immediate Change in Dorsiflexion Angle

  Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)

Study Arms (1)

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.

Device: Propulsion Neuroprosthesis

Interventions

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.

Neuroprosthesis-Assisted Walking Evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Harvard University: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• American Heart Association: collaborator

Study Sites (2)

Science and Engineering Complex

Boston, Massachusetts, 02134, United States

Location

Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (12)

• 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.

  PMID: 22796242 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.

  PMID: 19926681 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.

  PMID: 21401663 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.

  PMID: 19834018 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.

  PMID: 24378803 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.

  PMID: 10619100 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.

  PMID: 15996592 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.

  PMID: 31834220 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.

  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.

  PMID: 16456121 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.

  PMID: 30408710 BACKGROUND

• 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.

  PMID: 39157060 RESULT

Related Links

• Results Reference

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Data streaming issue led to two participants not having information about the timing of neurostimulation assistance during the gait cycle.

Results Point of Contact

• Title: Ashlyn Aiello
• Organization: Boston University

ajma@bu.edu

617-500-3645

Study Officials

• Louis Awad, PT, DPT, PhD

  Boston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants with stroke will complete study procedures that include walking with and without the intervention.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 14, 2024
• Study Start: February 22, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)