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StrokeNCT07218094

Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke

A study testing Walking with robotic ankle assistance in people with Stroke, run by Boston University Charles River Campus at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Stroke survivors often experience impaired neuromechanical control that limits walking speed and quality, particularly due to deficits in paretic propulsion. This study aims to identify patient-specific neuromechanical locomotor control strategies, link them to biomechanical gait impairments, and investigate how these… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Walking with robotic ankle assistance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years old
  • >6 months post-stroke
  • Observable gait deficits
  • Able to walk overground and on a treadmill without body-weight support
  • Able to communicate clearly with investigators and follow instructions
  • Able to fit the exosuit components, including height between 4'8" and 6'7", weight < 264lbs, neutral ankle dorsiflexion during standing.

Who cannot join

  • Comorbidities besides stroke that impair walking (musculoskeletal, cardiovascular, pulmonary, or neurological)
  • Severe pain, neglect, hemianopia, or aphasia limiting comprehension
  • Unexplained dizziness or more than 2 falls in the previous month
  • Inability to communicate (as assessed by a licensed physical therapist)
  • Inability to wear the exosuit due to conditions that require medical management, such as open wounds or broken skin, or as assessed by a licensed physical therapist.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Boston University Neuromotor Recovery Laboratory

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Stroke survivors often experience impaired neuromechanical control that limits walking speed and quality, particularly due to deficits in paretic propulsion. This study aims to identify patient-specific neuromechanical locomotor control strategies, link them to biomechanical gait impairments, and investigate how these strategies influence responses to soft robotic exosuit assistance of paretic propulsion and ground clearance during walking. The study focuses on adults who are more than six months post-stroke and have observable gait deficits.

The main questions are:

Read more
  1. How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
  2. Do individuals with distinct neuromechanical patterns respond differently to robotic exosuit-assisted gait rehabilitation?

Researchers will compare walking performance without and with robotic exosuit assistance to determine whether tailoring exosuit-assisted gait intervention to patient-specific neuromechanical profiles can lead to greater improvements in walking function. Participants will complete treadmill and overground walking assessments instrumented with motion capture, EMG, and force plates, performing one trial without assistance and two trials with robotic exosuit assistance delivered at different assistance onset timings, from which a preferred assistance setting will be identified. The walking trial associated with the preferred assistance setting will be used for primary analyses.

Conditions
Stroke
Being tested
Walking with robotic ankle assistance
Keywords
Stroke, Gait Disorders, Neurologic, Gait Analysis, Neuromuscular Control, Rehabilitation, Stroke, Exoskeleton Device, Biomechanics
Medical subject headings
Stroke, Gait Disorders, Neurologic

What participants receive

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

  • Walking with robotic ankle assistanceDevice

    Subjects will complete two trials of 3-minute treadmill walking with active robotic exosuit assistance, from which a preferred assistance profile will be identified. The treadmill walk associated with the preferred profile will be used for primary analyses.

Study groups in NCT07218094
Study groupRoleWhat they receive
Walking with and without robotic ankle assistanceExperimentalSubjects will complete a 3-minute treadmill walking trial with and without robotic ankle assistance
Receives: Device: Walking with robotic ankle assistance

What is being measured

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

  1. Dynamic Motor Control Index (DMCI)

    Difference in neuromuscular control quality compared to normative data with and without exosuit

    Measured: Baseline, Assisted (on average 1-2 hours)

  2. Correlation Between Propulsion and Weight-Acceptance Motor Modules (Temporal)

    Difference in the merging of motor module structures quantified by correlation coefficient between the propulsion temporal module and weight-acceptance temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit

    Measured: Baseline, Assisted (on average 1-2 hours)

  3. Correlation Between Weight-Acceptance and Swing-Limb Deceleration Motor Modules (Temporal)

    Difference in the merging of motor module structures quantified by correlation coefficient between the weight-acceptance temporal module and swing-limb deceleration temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit

    Measured: Baseline, Assisted (on average 1-2 hours)

  4. Variance Accounted For (VAF) by Four Muscle Synergies

    Difference in the variance in muscle activation accounted for by the 4-synergy model, measuring the quantitative shift in muscle coordination complexity with and without exosuit (%)

    Measured: Baseline, Assisted (on average 1-2 hours)

  5. Paretic Propulsion

    Difference in anterior-posterior ground reaction force with and without exosuit (N)

    Measured: Baseline, Assisted (on average 1-2 hours)

Secondary outcomes (3)
  1. Joint Angle

    Difference in joint angles computed using inverse dynamics, including ankle, knee, and hip angles, with and without exosuit (degrees)

    Measured: Baseline, Assisted (on average 1-2 hours)

  2. Joint Torque

    Difference in joint torques computed using inverse dynamics, including ankle, knee, and hip torques, with and without exosuit (Nm/kg)

    Measured: Baseline, Assisted (on average 1-2 hours)

  3. Joint Power

    Difference in joint power computed using inverse dynamics, including ankle, knee, and hip power, with and without exosuit (W/kg)

    Measured: Baseline, Assisted (on average 1-2 hours)

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 start11 Sep 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will complete a 3-minute treadmill walking trial without robotic exosuit assistance and then complete two trials with different assistance profiles from which a preferred profile will be identified.
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218094
Sponsor's protocol ID
4440
Status last verified
Aug 2026
First submitted
2 Oct 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified subject data with and without robotic ankle exosuit assistance may be published as part of the manuscript. Data may include kinematics, kinetics, and clinical data.

Publications

  • Awad LN, Esquenazi A, Francisco GE, Nolan KJ, Jayaraman A. The ReWalk ReStore soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation. J Neuroeng Rehabil. 2020 Jun 18;17(1):80. doi: 10.1186/s12984-020-00702-5.

    PubMed 32552775
  • Farris DJ, Hampton A, Lewek MD, Sawicki GS. Revisiting the mechanics and energetics of walking in individuals with chronic hemiparesis following stroke: from individual limbs to lower limb joints. J Neuroeng Rehabil. 2015 Feb 27;12:24. doi: 10.1186/s12984-015-0012-x.

    PubMed 25889030
  • Hsiao H, Awad LN, Palmer JA, Higginson JS, Binder-Macleod SA. Contribution of Paretic and Nonparetic Limb Peak Propulsive Forces to Changes in Walking Speed in Individuals Poststroke. Neurorehabil Neural Repair. 2016 Sep;30(8):743-52. doi: 10.1177/1545968315624780. Epub 2015 Dec 31.

    PubMed 26721869
  • 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.

    PubMed 16456121
  • Porciuncula F, Arumukhom Revi D, Baker TC, Sloutsky R, Walsh CJ, Ellis TD, Awad LN. Effects of high-intensity gait training with and without soft robotic exosuits in people post-stroke: a development-of-concept pilot crossover trial. J Neuroeng Rehabil. 2023 Nov 7;20(1):148. doi: 10.1186/s12984-023-01267-9.

    PubMed 37936135
  • Awad LN, Kudzia P, Revi DA, Ellis TD, Walsh CJ. Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. IEEE Open J Eng Med Biol. 2020;1:108-115. doi: 10.1109/ojemb.2020.2984429. Epub 2020 Apr 2.

    PubMed 33748765
  • Moucheboeuf G, Griffier R, Gasq D, Glize B, Bouyer L, Dehail P, Cassoudesalle H. Effects of robotic gait training after stroke: A meta-analysis. Ann Phys Rehabil Med. 2020 Nov;63(6):518-534. doi: 10.1016/j.rehab.2020.02.008. Epub 2020 Mar 27.

    PubMed 32229177
  • Collimore AN, Aiello AJ, Pohlig RT, Awad LN. The Dynamic Motor Control Index as a Marker of Age-Related Neuromuscular Impairment. Front Aging Neurosci. 2021 Jul 22;13:678525. doi: 10.3389/fnagi.2021.678525. eCollection 2021.

    PubMed 34366824
  • Steele KM, Rozumalski A, Schwartz MH. Muscle synergies and complexity of neuromuscular control during gait in cerebral palsy. Dev Med Child Neurol. 2015 Dec;57(12):1176-82. doi: 10.1111/dmcn.12826. Epub 2015 Jun 17.

    PubMed 26084733
  • Bizzi E, Cheung VC. The neural origin of muscle synergies. Front Comput Neurosci. 2013 Apr 29;7:51. doi: 10.3389/fncom.2013.00051. eCollection 2013.

    PubMed 23641212
  • Allen JL, Kautz SA, Neptune RR. The influence of merged muscle excitation modules on post-stroke hemiparetic walking performance. Clin Biomech (Bristol). 2013 Jul;28(6):697-704. doi: 10.1016/j.clinbiomech.2013.06.003. Epub 2013 Jul 2.

    PubMed 23830138
  • Neptune RR, Clark DJ, Kautz SA. Modular control of human walking: a simulation study. J Biomech. 2009 Jun 19;42(9):1282-7. doi: 10.1016/j.jbiomech.2009.03.009. Epub 2009 Apr 25.

    PubMed 19394023
  • Ting LH, Chiel HJ, Trumbower RD, Allen JL, McKay JL, Hackney ME, Kesar TM. Neuromechanical principles underlying movement modularity and their implications for rehabilitation. Neuron. 2015 Apr 8;86(1):38-54. doi: 10.1016/j.neuron.2015.02.042.

    PubMed 25856485
  • Sloot LH, Baker LM, Bae J, Porciuncula F, Clement BF, Siviy C, Nuckols RW, Baker T, Sloutsky R, Choe DK, O'Donnell K, Ellis TD, Awad LN, Walsh CJ. Effects of a soft robotic exosuit on the quality and speed of overground walking depends on walking ability after stroke. J Neuroeng Rehabil. 2023 Sep 1;20(1):113. doi: 10.1186/s12984-023-01231-7.

    PubMed 37658408
  • Awad LN, Lewek MD, Kesar TM, Franz JR, Bowden MG. These legs were made for propulsion: advancing the diagnosis and treatment of post-stroke propulsion deficits. J Neuroeng Rehabil. 2020 Oct 21;17(1):139. doi: 10.1186/s12984-020-00747-6.

    PubMed 33087137

Questions about this trial

What is this clinical trial studying?

A study testing Walking with robotic ankle assistance in people with Stroke, run by Boston University Charles River Campus at 1 site 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 6 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Dynamic Motor Control Index (DMCI) (time frame: Baseline, Assisted (on average 1-2 hours)). The study lists 5 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 NCT07218094, which also lists 19 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 11 Aug 2026.

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