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StrokeNCT07218107

Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic

A study testing Neurostimulation Exosuit in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Neurostimulation Exosuit
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesUnited States
Study dates
4 Jun 2024to 23 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Center for Neurorehabilitation

    Boston, Massachusetts, 02215

  • Neuromotor Recovery Laboratory

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic Using a Wearable Propulsion Neuroprosthesis

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.

Read the detailed description

Functional electrical stimulation (FES) is commonly used to manage foot drop in people with post-stroke hemiparesis. Emerging use of FES applied to the paretic plantarflexors to facilitate push-off ability during walking has been limited to the treadmill and highly supervised laboratory-based settings. This novel neurostimulation exosuit (i.e., neuroprosthesis) enables overground gait training in environments of varying complexity by giving clinicians the ability to modulate neurostimulation timing and intensity delivered to the dorsiflexors for swing-phase foot clearance and to the plantarflexors for stance-phase plantarflexor forward propulsion. Combined with progressive, high-intensity, task-specific gait training, as has been performed previously with soft robotic exosuits developed by the same research group, this propulsion neuroprosthesis will leverage i) immediate gait assistance from the neurostimulation to facilitate high intensity training without sacrificing gait quality and ii) neurorestorative properties of FES to encourage the recovery motor function to affected muscles.

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
Stroke
Being tested
Neurostimulation Exosuit
Keywords
functional electrical stimulation, neuroprosthesis, gait training, chronic stroke, exosuit, neurostimulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurostimulation ExosuitDevice

    Also called Neuroprosthesis

    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.

Study groups in NCT07218107
Study groupRoleWhat they receive
NEAT ProgramExperimentalNeurostimulation 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.
Receives: Device: Neurostimulation Exosuit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Pre-training Evaluation (baseline)

  2. 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).

    Measured: Post-training Evaluation (average of 5 weeks)

  3. 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).

    Measured: Pre-training Evaluation (baseline)

  4. 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).

    Measured: Post-training Evaluation (average of 5 weeks)

  5. 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).

    Measured: Pre-training Evaluation (baseline)

  6. 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).

    Measured: Post-training Evaluation (average of 5 weeks)

  7. 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.

    Measured: Pre-training Evaluation (baseline)

  8. 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.

    Measured: Post-training Evaluation (average of 5 weeks)

  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.

    Measured: Pre-training Evaluation (baseline)

  10. 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.

    Measured: Training Day 3

  11. 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.

    Measured: Training Day 6

  12. 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.

    Measured: Training Day 9

  13. 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.

    Measured: Post-training Evaluation (average of 5 weeks)

  14. 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.

    Measured: Pre-training Evaluation (baseline)

  15. 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.

    Measured: Post-training Evaluation (average of 5 weeks)

Secondary outcomes (6)

  1. System Usability Scale (SUS)

    This is a self-report measure of usability of a device. The assessment asks about complexity of the device, need for technical support, confidence in using the device, etc. Each of the 10 questions is rated from 1 (strongly disagree) to 5 (strongly agree) and scaled with a maximum score of 100.

    Measured: First Training Day (Day 1)

  2. System Usability Scale (SUS)

    This is a self-report measure of usability of a device. The assessment asks about complexity of the device, need for technical support, confidence in using the device, etc. Each of the 10 questions is rated from 1 (strongly disagree) to 5 (strongly agree) and scaled with a maximum score of 100.

    Measured: Mid-Training (Day 7)

  3. System Usability Scale (SUS)

    This is a self-report measure of usability of a device. The assessment asks about complexity of the device, need for technical support, confidence in using the device, etc. Each of the 10 questions is rated from 1 (strongly disagree) to 5 (strongly agree) and scaled with a maximum score of 100.

    Measured: Last Training Day (Day 12)

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

    This is a self-report measure of satisfaction with an assistive device. The assessment asks about various aspects of the device, such as size, weight, comfort, etc. The questions are rated from 1 (not satisfied at all) to 5 (very satisfied). This measure has been modified by the investigators to assess only the 8 questions related to device characteristics (i.e., removed questions related to technology services).

    Measured: First Training Day (Day 1)

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

    This is a self-report measure of satisfaction with an assistive device. The assessment asks about various aspects of the device, such as size, weight, comfort, etc. The questions are rated from 1 (not satisfied at all) to 5 (very satisfied). This measure has been modified by the investigators to assess only the 8 questions related to device characteristics (i.e., removed questions related to technology services).

    Measured: Mid-Training (Day 7)

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

    This is a self-report measure of satisfaction with an assistive device. The assessment asks about various aspects of the device, such as size, weight, comfort, etc. The questions are rated from 1 (not satisfied at all) to 5 (very satisfied). This measure has been modified by the investigators to assess only the 8 questions related to device characteristics (i.e., removed questions related to technology services).

    Measured: Last Training Day (Day 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start4 Jun 2024
  3. Primary completion23 Oct 2024
  4. Study completion23 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218107
Sponsor's protocol ID
5715-FESTx
Status last verified
Jul 2024
First submitted
2 Jul 2024
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 10619100

  • 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.

    PubMed 25889283

  • 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.

    PubMed 23254556

  • 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.

    PubMed 30619077

  • 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.

    PubMed 27819067

  • 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.

    PubMed 27663199

  • 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.

    PubMed 19834018

  • 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.

    PubMed 28339828

  • 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.

    PubMed 31834220

  • 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.

    PubMed 34393750

  • 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.

    PubMed 24378803

  • 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.

    PubMed 20692180

  • 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.

    PubMed 21183351

  • 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.

    PubMed 38391623

Questions about this trial

What is this clinical trial studying?

A study testing Neurostimulation Exosuit in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Minute Walk Test (6MWT) Distance (time frame: Pre-training Evaluation (baseline)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07218107, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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