Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic
NCT ID: NCT07218107
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2024-06-04
2024-10-23
Brief Summary
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Detailed Description
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The primary objective of this study seeks to understand the feasibility and rehabilitative effects of a Neurostimulation Exosuit Augmented Training (NEAT) program designed to provide high-intensity speed-driven gait training in progressively challenging environments. The investigators hypothesize that the NEAT program will safely provide a standard dose of gait rehabilitation training within a clinic setting and that the training will result in clinically meaningful gains in walking endurance and energy efficiency driven by improvements in forward propulsion and symmetry between limbs.
Secondary objectives of this study seek to assess the effects of the NEAT program on neuromuscular control to the paretic plantarflexors (i.e., central drive). The investigators hypothesize that repeated training with neurostimulation to the dorsiflexors and plantarflexors will result in increased neuromuscular control to the paretic plantarflexors.
The NEAT program will consist of 14 total study visits: i) Pre-training Evaluation, ii) NEAT Training (12 sessions, 2-3 times per week), iii) Post-training Evaluation. The neurostimulation exosuit used in this study was developed for investigational use only by investigators at the Boston University Neuromotor Recovery Laboratory, the Harvard University BioDesign Lab, and the Harvard University Move Lab.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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NEAT Program
Neurostimulation Exosuit Augmented Training (NEAT) refers to gait training with electrical stimulation exosuits, sometimes known as neuroprostheses. NEAT incorporates a speed-based approach that asks participants to walk at fast speeds on the treadmill and overground. Goal-directed walking practice if facilitated by a physical therapist who provides cues and feedback emphasizing a focus on increasing walking speed and forward propulsion. Training is progressively challenging based on environmental complexity and practice variability. NEAT includes 12 training sessions administered 2-3 times per week. Each session includes 30 minutes of gait training.
Neurostimulation Exosuit
A neurostimulation exosuit (i.e., neuroprosthesis) is a textile-based device worn on the paretic lower limb. Neuroprostheses deliver functional electrical stimulation through non-invasive surface electrodes placed on the front and the back of the leg, providing swing-phase dorsiflexor assistance for foot clearance and stance-phase plantarflexor assistance for forward propulsion, respectively. Neurostimulation assistance is provided synchronously with the wearer's gait, based on inertial sensors in the shoes that measure the wearer's unique walking pattern.
Interventions
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Neurostimulation Exosuit
A neurostimulation exosuit (i.e., neuroprosthesis) is a textile-based device worn on the paretic lower limb. Neuroprostheses deliver functional electrical stimulation through non-invasive surface electrodes placed on the front and the back of the leg, providing swing-phase dorsiflexor assistance for foot clearance and stance-phase plantarflexor assistance for forward propulsion, respectively. Neurostimulation assistance is provided synchronously with the wearer's gait, based on inertial sensors in the shoes that measure the wearer's unique walking pattern.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of stroke event occurring at least 6 months ago
* Observable gait deficits characteristic of post-stroke hemiparesis
* Independent ambulation for at least 30 meters (with an assistive device if needed but without a rigid brace for the ankle)
* Ankle dorsiflexion range of motion at least to neutral (i.e., 90 degrees between the shank and the foot)
* Resting heart rate between 40 - 100 bpm (inclusive)
* Resting blood pressure between 90/60 and 170/90 mmHg (inclusive)
* HIPAA authorization to allow communication with healthcare provider as needed during the study period
* Medical clearance by a physician
Exclusion Criteria
* Inability to communicate with investigators
* Visual neglect or hemianopia
* History of cerebellar stroke
* Actively receiving physical therapy for walking
* More than 2 unexplained falls in the previous month
* Pressure ulcers or skin wounds located near human-device interface sites
* Pacemakers or similar electrical implants that could be affected by electrical stimulation
* Metal implants directly under the stimulation sites
* Skin allergy or other condition sensitive to the adhesive from transcutaneous neurostimulation electrode pads
* Other medical, orthopedic, and neurological conditions that prevent full participation in the research
18 Years
80 Years
ALL
No
Sponsors
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Harvard University
OTHER
Boston University Charles River Campus
OTHER
Responsible Party
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Lou Awad, PT, DPT, PhD
Associate Professor, Physical Therapy
Principal Investigators
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Louis Awad, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Center for Neurorehabilitation
Boston, Massachusetts, United States
Neuromotor Recovery Laboratory
Boston, Massachusetts, United States
Countries
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References
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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.
Takahashi KZ, Lewek MD, Sawicki GS. A neuromechanics-based powered ankle exoskeleton to assist walking post-stroke: a feasibility study. J Neuroeng Rehabil. 2015 Feb 25;12:23. doi: 10.1186/s12984-015-0015-7.
Bowden MG, Woodbury ML, Duncan PW. Promoting neuroplasticity and recovery after stroke: future directions for rehabilitation clinical trials. Curr Opin Neurol. 2013 Feb;26(1):37-42. doi: 10.1097/WCO.0b013e32835c5ba0.
Allen JL, Ting LH, Kesar TM. Gait Rehabilitation Using Functional Electrical Stimulation Induces Changes in Ankle Muscle Coordination in Stroke Survivors: A Preliminary Study. Front Neurol. 2018 Dec 20;9:1127. doi: 10.3389/fneur.2018.01127. eCollection 2018.
Kesar TM, Reisman DS, Higginson JS, Awad LN, Binder-Macleod SA. Changes in Post-Stroke Gait Biomechanics Induced by One Session of Gait Training. Phys Med Rehabil Int. 2015;2(10):1072. Epub 2015 Dec 28.
Awad LN, Reisman DS, Pohlig RT, Binder-Macleod SA. Identifying candidates for targeted gait rehabilitation after stroke: better prediction through biomechanics-informed characterization. J Neuroeng Rehabil. 2016 Sep 23;13(1):84. doi: 10.1186/s12984-016-0188-8.
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.
Palmer JA, Hsiao H, Wright T, Binder-Macleod SA. Single Session of Functional Electrical Stimulation-Assisted Walking Produces Corticomotor Symmetry Changes Related to Changes in Poststroke Walking Mechanics. Phys Ther. 2017 May 1;97(5):550-560. doi: 10.1093/ptj/pzx008.
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.
Porciuncula F, Baker TC, Arumukhom Revi D, Bae J, Sloutsky R, Ellis TD, Walsh CJ, Awad LN. Targeting Paretic Propulsion and Walking Speed With a Soft Robotic Exosuit: A Consideration-of-Concept Trial. Front Neurorobot. 2021 Jul 28;15:689577. doi: 10.3389/fnbot.2021.689577. eCollection 2021.
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.
Sabut SK, Lenka PK, Kumar R, Mahadevappa M. Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects. J Electromyogr Kinesiol. 2010 Dec;20(6):1170-7. doi: 10.1016/j.jelekin.2010.07.003. Epub 2010 Aug 6.
Kesar TM, Reisman DS, Perumal R, Jancosko AM, Higginson JS, Rudolph KS, Binder-Macleod SA. Combined effects of fast treadmill walking and functional electrical stimulation on post-stroke gait. Gait Posture. 2011 Feb;33(2):309-13. doi: 10.1016/j.gaitpost.2010.11.019. Epub 2010 Dec 22.
Collimore AN, Alvarez JT, Sherman DA, Gerez LF, Barrow N, Choe DK, Binder-Macleod S, Walsh CJ, Awad LN. A Portable, Neurostimulation-Integrated, Force Measurement Platform for the Clinical Assessment of Plantarflexor Central Drive. Bioengineering (Basel). 2024 Jan 30;11(2):137. doi: 10.3390/bioengineering11020137.
Other Identifiers
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5715-FESTx
Identifier Type: -
Identifier Source: org_study_id
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