Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic

NCT07218107 | Completed FDA Device

• 1 other identifier: 5715-FESTx
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

The primary goal of this study is to understand the feasibility and rehabilitative effects of a Neurostimulation Exosuit Augmented Training (NEAT) program designed to provide high-intensity gait training in progressively challenging environments for individuals in the chronic phase of stroke recovery. The investigators will monitor feasibility of the training program and assess walking endurance and energy efficiency before and after the training to quantify effects of the training program on the recovery of walking function driven by improvements in forward propulsion and symmetry between limbs. Participants will complete pre-training and post-training evaluations alongside 12 gait training sessions across 4-5 weeks.

Conditions

Stroke

Keywords

functional electrical stimulation; neuroprosthesis; gait training; chronic stroke; exosuit; neurostimulation

Outcome Measures

Primary Outcomes (15)

• Six Minute Walk Test (6MWT) Distance

  This is a clinical test of long-distance walking function. The participant walks as far as they can safely in 6 minutes. Total distance covered in 6 minutes is the primary outcome from this test. This test will be performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Pre-training Evaluation (baseline)

• Six Minute Walk Test (6MWT) Distance

  This is a clinical test of long-distance walking function. The participant walks as far as they can safely in 6 minutes. Total distance covered in 6 minutes is the primary outcome from this test. This test will be performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Post-training Evaluation (average of 5 weeks)

• Six Minute Walk Test (6MWT) Speed

  Walking speed is also monitored during the 6MWT at each reference length completed (e.g., 30-meter stretch before turning around). Speed is calculated as the reference length divided by the time it took to walk that distance in meters per second (m/s). This metric will be measured during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Pre-training Evaluation (baseline)

• Six Minute Walk Test (6MWT) Speed

  Walking speed is assessed during the 6MWT at each reference length completed (e.g., 30-meter stretch before turning around). Speed is calculated as the reference length divided by the time it took to walk that distance in meters per second (m/s). This metric is assessed during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Post-training Evaluation (average of 5 weeks)

• Energy Expenditure

  Energy expenditure assessed using indirect calorimetry (COSMED K5) and is calculated as the volume of oxygen inhaled normalized by bodyweight and distance (mL O2/kg/m). This metric will be measured during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Pre-training Evaluation (baseline)

• Energy Expenditure

  Energy expenditure assessed using indirect calorimetry (COSMED K5) and is calculated as the volume of oxygen inhaled normalized by bodyweight and distance (mL O2/kg/m). This metric will be measured during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).

  Post-training Evaluation (average of 5 weeks)

• Ten Meter Walk Test (10mWT) Speed

  This is a clinical test of short-distance walking function. The participant walks at a comfortable walking speed (CWS) and fast walking speed (FWS) on a 10-meter straight walkway. The middle six meters are used to assess speed across 3 trials for CWS and 3 trials for FWS.

  Pre-training Evaluation (baseline)

• Ten Meter Walk Test (10mWT) Speed

  This is a clinical test of short-distance walking function. The participant walks at a comfortable walking speed (CWS) and fast walking speed (FWS) on a 10-meter straight walkway. The middle six meters are used to assess speed across 3 trials for CWS and 3 trials for FWS.

  Post-training Evaluation (average of 5 weeks)

• Plantarflexor Central Drive

  Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.

  Pre-training Evaluation (baseline)

• Plantarflexor Central Drive

  Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.

  Training Day 3

• Plantarflexor Central Drive

  Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.

  Training Day 6

• Plantarflexor Central Drive

  Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.

  Training Day 9

• Plantarflexor Central Drive

  Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.

  Post-training Evaluation (average of 5 weeks)

• Gait Propulsion

  Propulsion is the anterior component of the ground reaction force corresponding to the push-off subtask of walking that propels a forward into the next step. Gait propulsion is assessed during the 6MWT using floor-embedded forceplates.

  Pre-training Evaluation (baseline)

• Gait Propulsion

  Propulsion is the anterior component of the ground reaction force corresponding to the push-off subtask of walking that propels a forward into the next step. Gait propulsion is assessed during the 6MWT using floor-embedded forceplates.

  Post-training Evaluation (average of 5 weeks)

Secondary Outcomes (6)

• System Usability Scale (SUS)

  First Training Day (Day 1)

• System Usability Scale (SUS)

  Mid-Training (Day 7)

• System Usability Scale (SUS)

  Last Training Day (Day 12)

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) - Modified

  First Training Day (Day 1)

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) - Modified

  Mid-Training (Day 7)

Other Outcomes (8)

• Functional Gait Assessment (FGA)

  Pre-training Evaluation (baseline)

• Fugl-Meyer Assessment Lower Extremity Subsection (FMLE)

  Pre-training Evaluation (baseline)

• Physical Activity Scale for the Elderly (PASE) - Modified

  Pre-training Evaluation (baseline)

Study Arms (1)

NEAT Program

EXPERIMENTAL

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.

Device: Neurostimulation Exosuit

Interventions

Neurostimulation Exosuit DEVICE

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.

Also known as: Neuroprosthesis

NEAT Program

Eligibility Criteria

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

You may qualify if:

• Age 18 - 80 years old
• 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

You may not qualify if:

• NIH Stroke Scale Question 1b score \> 1 and Question 1c score \> 0
• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Harvard University: collaborator

Study Sites (2)

Center for Neurorehabilitation

Boston, Massachusetts, 02215, United States

Location

Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (14)

• 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

• 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.

  PMID: 25889283 BACKGROUND

• 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.

  PMID: 23254556 BACKGROUND

• 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.

  PMID: 30619077 BACKGROUND

• 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.

  PMID: 27819067 BACKGROUND

• 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.

  PMID: 27663199 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

• 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.

  PMID: 28339828 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

• 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.

  PMID: 34393750 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

• 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.

  PMID: 20692180 BACKGROUND

• 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.

  PMID: 21183351 BACKGROUND

• 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.

  PMID: 38391623 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Louis Awad, PT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Physical Therapy

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: October 20, 2025
• Study Start: June 4, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: October 20, 2025

Record last verified: 2024-07

Locations

US (2)