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.
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
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
- How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
- 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 group | Role | What they receive |
|---|---|---|
| Walking with and without robotic ankle assistance | Experimental | Subjects 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.
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)
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)
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)
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)
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)
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)
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)
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.
- First posted20 Oct 2025
- Study start11 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis N Awad, PT, DPT, PhD, Principal investigator, Boston University Charles River Campus
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 32552775Farris 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 25889030Hsiao 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 26721869Bowden 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 16456121Porciuncula 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 37936135Awad 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 33748765Moucheboeuf 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 32229177Collimore 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 34366824Steele 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 26084733Bizzi 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 23641212Allen 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 23830138Neptune 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 19394023Ting 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 25856485Sloot 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 37658408Awad 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT07218094
- Acronym / sponsor ID
- 4440
- Conditions
- Stroke
- Keywords
- Stroke, Gait Disorders, Neurologic, Gait Analysis, Neuromuscular Control, Rehabilitation, Stroke, Exoskeleton Device, Biomechanics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking with and without robotic ankle assistance | Experimental | Device: Walking with robotic ankle assistanceSubjects will complete a 3-minute treadmill walking trial with and without robotic ankle assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking with robotic ankle assistanceSubjects 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. | Device | Walking with and without robotic ankle assistance |
Primary outcome
Dynamic Motor Control Index (DMCI)
Time frame: Baseline, Assisted (on average 1-2 hours)
Difference in neuromuscular control quality compared to normative data with and without exosuit
Correlation Between Propulsion and Weight-Acceptance Motor Modules (Temporal)
Time frame: Baseline, Assisted (on average 1-2 hours)
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
Correlation Between Weight-Acceptance and Swing-Limb Deceleration Motor Modules (Temporal)
Time frame: Baseline, Assisted (on average 1-2 hours)
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
Variance Accounted For (VAF) by Four Muscle Synergies
Time frame: Baseline, Assisted (on average 1-2 hours)
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 (%)
Paretic Propulsion
Time frame: Baseline, Assisted (on average 1-2 hours)
Difference in anterior-posterior ground reaction force with and without exosuit (N)
3 secondary outcomes
Joint Angle
Time frame: Baseline, Assisted (on average 1-2 hours)
Joint Torque
Time frame: Baseline, Assisted (on average 1-2 hours)
Joint Power
Time frame: Baseline, Assisted (on average 1-2 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 32552775Awad 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.
- Background: PubMed 25889030Farris 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.
- Background: PubMed 26721869Hsiao 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.
- Background: PubMed 16456121Bowden 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.
- Background: PubMed 37936135Porciuncula 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.
- Background: PubMed 33748765Awad 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.
- Background: PubMed 32229177Moucheboeuf 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.
- Background: PubMed 34366824Collimore 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.
- Background: PubMed 26084733Steele 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.
- Background: PubMed 23641212Bizzi 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.
- Background: PubMed 23830138Allen 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.
- Background: PubMed 19394023Neptune 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis N Awad, PT, DPT, PhD principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
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.