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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06459401
• Other study ID #: 5715
• Secondary ID: 830019U54EB01540
• Status: Completed
• Phase: Early Phase 1
• Start date: February 22, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: June 2024
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Neuromotor Recovery Laboratory	Boston	Massachusetts
United States	Science and Engineering Complex	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Harvard University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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, Avon). 1999 Feb;14(2):125-35. doi: 10.1016/s0268-0033(98)00062-x. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Speed without neurostimulation assistance	Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.	Immediate Pre-session 10-meter walk test
Primary	Walking Speed without neurostimulation assistance	Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.	Immediate Post-session 10-meter walk test
Primary	Walking Speed without neurostimulation assistance	Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.	During session 10-meter walk test
Primary	Walking Speed with neurostimulation assistance	Walking speed is measured at self-selected comfortable and fast paces using the 10-Meter Walk Test.	During session 10-meter walk test
Primary	Paretic Propulsion without neurostimulation assistance	Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.	Immediate Pre-session 10-meter walk test
Primary	Paretic Propulsion without neurostimulation assistance	Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.	Immediate Post-session 10-meter walk test
Primary	Paretic Propulsion without neurostimulation assistance	Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.	During session 10-meter walk test
Primary	Paretic Propulsion with neurostimulation assistance	Paretic propulsion is measured as the peak anterior-posterior ground reaction force of the paretic limb.	During session 10-meter walk test
Primary	Propulsion Impulse without neurostimulation assistance	Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.	Immediate Pre-session 10-meter walk test
Primary	Propulsion Impulse without neurostimulation assistance	Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.	Immediate Post-session 10-meter walk test
Primary	Propulsion Impulse without neurostimulation assistance	Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.	During session 10-meter walk test
Primary	Propulsion Impulse with neurostimulation assistance	Propulsion impulse is measured as the area under the positive portion of the anterior-posterior ground reaction force curve.	During session 10-meter walk test
Primary	Propulsion Symmetry without neurostimulation assistance	Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).	Immediate Pre-session 10-meter walk test
Primary	Propulsion Symmetry without neurostimulation assistance	Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).	Immediate Post-session 10-meter walk test
Primary	Propulsion Symmetry without neurostimulation assistance	Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).	During session 10-meter walk test
Primary	Propulsion Symmetry with neurostimulation assistance	Propulsion symmetry is calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic).	During session 10-meter walk test
Secondary	Ankle Angle without neurostimulation assistance	Ankle angle is the angle between the foot and the shank measured using optical motion capture.	Immediate Pre-session 10-meter walk test
Secondary	Ankle Angle without neurostimulation assistance	Ankle angle is the angle between the foot and the shank measured using optical motion capture.	Immediate Post-session 10-meter walk test
Secondary	Ankle Angle without neurostimulation assistance	Ankle angle is the angle between the foot and the shank measured using optical motion capture.	During session 10-meter walk test
Secondary	Ankle Angle with neurostimulation assistance	Ankle angle is the angle between the foot and the shank measured using optical motion capture.	During session 10-meter walk test
Secondary	Knee Angle without neurostimulation assistance	Knee angle is the angle between the shank and the thigh measured using optical motion capture.	Immediate Pre-session 10-meter walk test
Secondary	Knee Angle without neurostimulation assistance	Knee angle is the angle between the shank and the thigh measured using optical motion capture.	Immediate Post-session 10-meter walk test
Secondary	Knee Angle without neurostimulation assistance	Knee angle is the angle between the shank and the thigh measured using optical motion capture.	During session 10-meter walk test
Secondary	Knee Angle with neurostimulation assistance	Knee angle is the angle between the shank and the thigh measured using optical motion capture.	During session 10-meter walk test
Secondary	Ankle Moment without neurostimulation assistance	Ankle moment is the rotation force of the foot measured using optical motion capture.	Immediate Pre-session 10-meter walk test
Secondary	Ankle Moment without neurostimulation assistance	Ankle moment is the rotation force of the foot measured using optical motion capture.	Immediate Post-session 10-meter walk test
Secondary	Ankle Moment without neurostimulation assistance	Ankle moment is the rotation force of the foot measured using optical motion capture.	During session 10-meter walk test
Secondary	Ankle Moment with neurostimulation assistance	Ankle moment is the rotation force of the foot measured using optical motion capture.	During session 10-meter walk test
Secondary	Ankle Power without neurostimulation assistance	Ankle power is the rate of change in ankle moment measured using optical motion capture.	Immediate Pre-session 10-meter walk test
Secondary	Ankle Power without neurostimulation assistance	Ankle power is the rate of change in ankle moment measured using optical motion capture.	Immediate Post-session 10-meter walk test
Secondary	Ankle Power without neurostimulation assistance	Ankle power is the rate of change in ankle moment measured using optical motion capture.	During session 10-meter walk test
Secondary	Ankle Power with neurostimulation assistance	Ankle power is the rate of change in ankle moment measured using optical motion capture.	During session 10-meter walk test