Clinical trial NCT06459401: Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
Official title: Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: Gait Rehabilitation
Functional Electrical Stimulation (FES)
Stroke
Exosuit
Propulsion
Neuroprosthesis
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2024-06-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants with stroke will complete study procedures that include walking with and without the intervention.
Primary purpose: TREATMENT

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

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

Ten individuals with chronic post-stroke hemiparesis will complete a single session of walking with and without the neuroprosthesis. Study evaluations will be conducted both before and after the session, without the neuroprosthesis active, and during the neuroprosthesis-supported walking.

Eligibility criteria: 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

Primary outcomes:
measure: Walking Speed without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Walking Speed without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Walking Speed without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Walking Speed with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Paretic Propulsion without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Paretic Propulsion without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Paretic Propulsion without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Paretic Propulsion with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Propulsion Impulse without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Propulsion Impulse without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Propulsion Impulse without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Propulsion Impulse with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Propulsion Symmetry without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Propulsion Symmetry without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Propulsion Symmetry without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Propulsion Symmetry with neurostimulation assistance
timeFrame: During session 10-meter walk test
Secondary outcomes:
measure: Ankle Angle without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Ankle Angle without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Ankle Angle without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Ankle Angle with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Knee Angle without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Knee Angle without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Knee Angle without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Knee Angle with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Ankle Moment without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Ankle Moment without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Ankle Moment without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Ankle Moment with neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Ankle Power without neurostimulation assistance
timeFrame: Immediate Pre-session 10-meter walk test
measure: Ankle Power without neurostimulation assistance
timeFrame: Immediate Post-session 10-meter walk test
measure: Ankle Power without neurostimulation assistance
timeFrame: During session 10-meter walk test
measure: Ankle Power with neurostimulation assistance
timeFrame: During session 10-meter walk test
Other outcomes:
Locations:
city: Boston
country: United States
facility: Science and Engineering Complex
state: Massachusetts
city: Boston
country: United States
facility: Neuromotor Recovery Laboratory
state: Massachusetts
Study officials:
affiliation: Boston University
name: Louis Awad, PT, DPT, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.