StrokeNCT07212608
Personalized Post-Stroke Gait Rehabilitation Interventions
A study testing Soft robotic exosuit and Propulsion neuroprosthesis in people with Stroke, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to different walking rehabilitation interventions that augment paretic limb propulsion (e.g., soft robotic exosuits or electrical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Soft robotic exosuit and Propulsion neuroprosthesis
- 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
- 13 Sep 2022to 24 Apr 2025
- 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
- Diagnosis of a stroke event occurring at least 6 months ago
- Observable gait deficits
- Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended
- Ability to follow a 3-step command
- Resting heart rate between 40-100 bpm
Show all 10Show fewer
- Resting blood pressure between 90/60 and 170/90 mmHg
- NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- HIPAA authorization to allow communication with healthcare provider
- Medical clearance by a physician
Who cannot join
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Serious comorbidities that may interfere with ability to participate in the research (e.g., musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by the FES
- Pressure ulcers or skin wounds located near human-device interface sites
- More than 2 unexplained falls in the previous month
- Actively receiving physical therapy for walking
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, 02215
About this study
Official title: Wearable Gait Interventions for Augmenting Paretic Propulsion: Towards Personalized Post-Stroke Gait Rehabilitation
The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to different walking rehabilitation interventions that augment paretic limb propulsion (e.g., soft robotic exosuits or electrical stimulation neuroprostheses). The results of this work could improve post-stroke gait recovery outcomes by informing clinical decision-making to better match patients with rehabilitation devices tailored to their specific gait characteristics.
Read the detailed description
Stroke is a leading cause of long-term disability that results in slow, asymmetrical, and inefficient walking. Personalized treatments matching patients to the treatments with which they are most likely to respond are not typical but are necessary to maximize recovery.
Post-stroke hemiparesis is commonly associated with reduced paretic limb propulsion that leads to slower, less efficient walking patterns. Our team has developed and tested two rehabilitation technologies targeting paretic propulsion: i) a soft robotic exosuit that uses cables to mechanically assist ankle dorsiflexion and plantarflexion during walking; ii) a neuroprosthesis that uses functional electrical stimulation (FES) to activate the dorsiflexor and plantarflexor muscles during walking. Both technologies aim to safely improve walking speed and paretic propulsion. The objective of this study is to evaluate if certain post-stroke patient subsets, identified from baseline clinical, biomechanical, and neuromuscular characteristics, preferentially respond to propulsion rehabilitation using soft robotic exosuits or electrical stimulation neuroprostheses.
Twenty participants with chronic (>6 months) stroke will complete one baseline gait evaluation in the laboratory and two gait training sessions: i) an exosuit day and ii) a neuroprosthesis day. Each visit will include walking with/without the respective technology.
The primary aim of this study is to identify predictors of a therapeutic response (i.e., improvement in walking speed) to determine whether certain patient subsets preferentially respond to the exosuit or the neuroprosthesis. We will evaluate baseline clinical, biomechanical, and neuromuscular abilities as potential predictors of a response. We hypothesize that a subset of individuals will respond preferentially to each intervention and that baseline measures of gait function will predict responders to each intervention.
A secondary aim of this study is to determine the rehabilitation mechanism underlying improved walking speed after walking with the propulsion exosuit and the neuroprosthesis. Improvements in walking speed can be achieved through recovery (e.g., increased propulsion symmetry) or compensation (e.g., increased nonparetic propulsion). We will independently evaluate the underlying biomechanical changes contributing to improvements in speed and metabolic cost. We hypothesize that both the exosuit and neuroprosthesis will promote improved speed via recovery of paretic propulsion.
- Conditions
- Stroke
- Being tested
- Soft robotic exosuit, Propulsion neuroprosthesis
- Keywords
- Exosuit, Neuroprosthesis, Soft Robotics, Wearable Robots, Gait Rehabilitation, Propulsion, Functional Electrical Stimulation (FES), Stroke, Neuromuscular Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft robotic exosuitDevice
A soft robotic exosuit is a textile-based system worn on the waist and paretic lower limb that provides assistive torques via cables connecting the front and back of the ankle to anchor points on the shank. The exosuit provides dorsiflexion assistance during swing phase for foot clearance and plantarflexion assistance during stance phase for propulsion delivered synchronously based on integrated sensors detecting the wearer's gait pattern.
Propulsion neuroprosthesisDevice
A neuroprosthesis is a textile-based, surface electrical stimulation system worn on the waist and paretic lower limb that delivers stimulation assistance via electroconductive pads placed on the skin over the target muscles. The neuroprosthesis provides coordinated dorsiflexor stimulation during swing phase for foot clearance and plantarflexor stimulation during stance phase for propulsion, delivered synchronously based on integrated sensors detecting the wearer's gait pattern.
| Study group | Role | What they receive |
|---|---|---|
| Exosuit Training | Experimental | A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with a soft robotic exosuit powered on and off. Shorter overground and treadmill evaluations without the exosuit will be completed immediately before and after the training. Receives: Device: Soft robotic exosuit |
| Neuroprosthesis Training | Active comparator | A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with the propulsion neuroprosthesis powered on and off. Shorter overground and treadmill evaluations without neurostimulation will be completed immediately before and after the training. Receives: Device: Propulsion neuroprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unassisted Overground Comfortable Walking Speed (Exosuit Day)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Fast Walking Speed (Exosuit Day)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Propulsion on Treadmill (Exosuit Day)
Paretic propulsion during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Energy Efficiency on Treadmill (Exosuit Day)
Energy efficiency during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Comfortable Walking Speed (Neuroprosthesis Day)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Fast Walking Speed (Neuroprosthesis Day)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Propulsion on Treadmill (Neuroprosthesis Day)
Paretic propulsion during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Energy Efficiency on Treadmill (Neuroprosthesis Day)
Energy efficiency during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
Measured: Periprocedural (Before); Periprocedural (After)
Secondary outcomes (10)
Unassisted Overground Paretic Propulsion at Comfortable Speed (Exosuit Day)
Paretic propulsion during walking without assistance at a self-selected comfortable pace during the 10-Meter Walk Test on the training day with the soft robotic exosuit. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Exosuit Day)
Paretic trailing limb angle during walking without assistance at a self-selected comfortable pace during the 10-Meter Walk Test on the training day with the soft robotic exosuit. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Fast Speed (Exosuit Day)
Paretic propulsion during walking without assistance at a self-selected fast pace during the 10-Meter Walk Test on the training day with the soft robotic exosuit. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Exosuit Day)
Paretic trailing limb angle during walking without assistance at a self-selected fast pace during the 10-Meter Walk Test on the training day with the soft robotic exosuit. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Trailing Limb Angle on Treadmill (Exosuit Day)
Paretic trailing limb angle during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Comfortable Speed (Neuroprosthesis Day)
Paretic propulsion during walking without assistance at a self-selected comfortable pace during the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Neuroprosthesis Day)
Paretic trailing limb angle during walking without assistance at a self-selected comfortable pace during the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Fast Speed (Neuroprosthesis Day)
Paretic propulsion during walking without assistance at a self-selected fast pace during the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Neuroprosthesis Day)
Paretic trailing limb angle during walking without assistance at a self-selected fast pace during the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Trailing Limb Angle on Treadmill (Neuroprosthesis Day)
Paretic trailing limb angle during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic trailing limb angle is the peak angle that the paretic limb makes during terminal stance phase with respect to vertical. Trailing limb angle is measured from the fifth metatarsal head to the greater trochanter with respect to vertical.
Measured: Periprocedural (Before); Periprocedural (After)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start13 Sep 2022
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete a baseline evaluation followed by two training days in a randomly assigned order. The training days are randomized between i) propulsion neuroprosthesis, ii) soft robotic exosuit.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, American Heart Association, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Lou Awad, PT, DPT, PhD, Boston University Charles River Campus
- Investigators
- Louis N Awad, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212608
- Sponsor's protocol ID
- 5715-FEX
- Other IDs
- U54EB015408, 830019
- Status last verified
- Oct 2025
- First submitted
- 28 Mar 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Awad LN, Bae J, O'Donnell K, et al. Soft exosuits increase walking speed and distance after stroke. In: International Symposium on Wearable Robotics and Rehabilitation (WeRob). Houston, TX: IEEE; 2; 2017.
Awad LN, Bae J, Kudzia P, Long A, Hendron K, Holt KG, O'Donnell K, Ellis TD, Walsh CJ. Reducing Circumduction and Hip Hiking During Hemiparetic Walking Through Targeted Assistance of the Paretic Limb Using a Soft Robotic Exosuit. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S157-S164. doi: 10.1097/PHM.0000000000000800.
PubMed 28777105Awad LN, Bae J, O'Donnell K, De Rossi SMM, Hendron K, Sloot LH, Kudzia P, Allen S, Holt KG, Ellis TD, Walsh CJ. A soft robotic exosuit improves walking in patients after stroke. Sci Transl Med. 2017 Jul 26;9(400):eaai9084. doi: 10.1126/scitranslmed.aai9084.
PubMed 28747517Bae J, Awad LN, Long A, O'Donnell K, Hendron K, Holt KG, Ellis TD, Walsh CJ. Biomechanical mechanisms underlying exosuit-induced improvements in walking economy after stroke. J Exp Biol. 2018 Mar 7;221(Pt 5):jeb168815. doi: 10.1242/jeb.168815.
PubMed 29361587Ardestani MM, Kinnaird CR, Henderson CE, Hornby TG. Compensation or Recovery? Altered Kinetics and Neuromuscular Synergies Following High-Intensity Stepping Training Poststroke. Neurorehabil Neural Repair. 2019 Jan;33(1):47-58. doi: 10.1177/1545968318817825. Epub 2018 Dec 29.
PubMed 30595090Paci M. Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies. J Rehabil Med. 2003 Jan;35(1):2-7. doi: 10.1080/16501970306106.
PubMed 12610841Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.
PubMed 30408710Bowden 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 16456121Bae J, Siviy C, Rouleau M, et al. A lightweight and efficient portable soft exosuit for paretic ankle assistance in walking after stroke. Proc - IEEE Int Conf Robot Autom. 2018:2820-2827. doi:10.1109/ICRA.2018.8461046
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 33748765Porciuncula F, Arumukhom Revi D, Baker TC, et al. Speed-Based Gait Training with Soft Robotic Exosuits Improves Walking after Stroke: A Crossover Pilot Study. In: American Physical Therapy Association Combined Sections Meeting.; 2021.
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 27819067Awad 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 27663199Reisman D, Kesar T, Perumal R, Roos M, Rudolph K, Higginson J, Helm E, Binder-Macleod S. Time course of functional and biomechanical improvements during a gait training intervention in persons with chronic stroke. J Neurol Phys Ther. 2013 Dec;37(4):159-65. doi: 10.1097/NPT.0000000000000020.
PubMed 24189337Awad LN, Kesar TM, Reisman D, Binder-Macleod SA. Effects of repeated treadmill testing and electrical stimulation on post-stroke gait kinematics. Gait Posture. 2013 Jan;37(1):67-71. doi: 10.1016/j.gaitpost.2012.06.001. Epub 2012 Jul 15.
PubMed 22796242
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Gait Interventions for Augmenting Paretic Propulsion: Towards Personalized Post-Stroke Gait Rehabilitation
- ClinicalTrials.gov ID
- NCT07212608
- Acronym / sponsor ID
- 5715-FEX
- Conditions
- Stroke
- Keywords
- Exosuit, Neuroprosthesis, Soft Robotics, Wearable Robots, Gait Rehabilitation, Propulsion, Functional Electrical Stimulation (FES), Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Harvard University, American Heart Association, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 8 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.
The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to different walking rehabilitation interventions that augment paretic limb propulsion (e.g., soft robotic exosuits or electrical stimulation neuroprostheses). The results of this work could improve post-stroke gait recovery outcomes by informing clinical decision-making to better match patients with rehabilitation devices tailored to their specific gait characteristics.
Detailed description
Stroke is a leading cause of long-term disability that results in slow, asymmetrical, and inefficient walking. Personalized treatments matching patients to the treatments with which they are most likely to respond are not typical but are necessary to maximize recovery.
Post-stroke hemiparesis is commonly associated with reduced paretic limb propulsion that leads to slower, less efficient walking patterns. Our team has developed and tested two rehabilitation technologies targeting paretic propulsion: i) a soft robotic exosuit that uses cables to mechanically assist ankle dorsiflexion and plantarflexion during walking; ii) a neuroprosthesis that uses functional electrical stimulation (FES) to activate the dorsiflexor and plantarflexor muscles during walking. Both technologies aim to safely improve walking speed and paretic propulsion. The objective of this study is to evaluate if certain post-stroke patient subsets, identified from baseline clinical, biomechanical, and neuromuscular characteristics, preferentially respond to propulsion rehabilitation using soft robotic exosuits or electrical stimulation neuroprostheses.
Twenty participants with chronic (>6 months) stroke will complete one baseline gait evaluation in the laboratory and two gait training sessions: i) an exosuit day and ii) a neuroprosthesis day. Each visit will include walking with/without the respective technology.
The primary aim of this study is to identify predictors of a therapeutic response (i.e., improvement in walking speed) to determine whether certain patient subsets preferentially respond to the exosuit or the neuroprosthesis. We will evaluate baseline clinical, biomechanical, and neuromuscular abilities as potential predictors of a response. We hypothesize that a subset of individuals will respond preferentially to each intervention and that baseline measures of gait function will predict responders to each intervention.
A secondary aim of this study is to determine the rehabilitation mechanism underlying improved walking speed after walking with the propulsion exosuit and the neuroprosthesis. Improvements in walking speed can be achieved through recovery (e.g., increased propulsion symmetry) or compensation (e.g., increased nonparetic propulsion). We will independently evaluate the underlying biomechanical changes contributing to improvements in speed and metabolic cost. We hypothesize that both the exosuit and neuroprosthesis will promote improved speed via recovery of paretic propulsion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will complete a baseline evaluation followed by two training days in a randomly assigned order. The training days are randomized between i) propulsion neuroprosthesis, ii) soft robotic exosuit.
| Arm | Type | Receives |
|---|---|---|
| Exosuit Training | Experimental | Device: Soft robotic exosuitA single 30-minute training of goal-directed overground walking practice at a moderately fast speed with a soft robotic exosuit powered on and off. Shorter overground and treadmill evaluations without the exosuit will be completed immediately before and after the training. |
| Neuroprosthesis Training | Active comparator | Device: Propulsion neuroprosthesisA single 30-minute training of goal-directed overground walking practice at a moderately fast speed with the propulsion neuroprosthesis powered on and off. Shorter overground and treadmill evaluations without neurostimulation will be completed immediately before and after the training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of a stroke event occurring at least 6 months ago
- Observable gait deficits
- Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended
- Ability to follow a 3-step command
Key exclusion criteria (8 listed)
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Serious comorbidities that may interfere with ability to participate in the research (e.g., musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by the FES
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 |
|---|---|---|
| Soft robotic exosuitA soft robotic exosuit is a textile-based system worn on the waist and paretic lower limb that provides assistive torques via cables connecting the front and back of the ankle to anchor points on the shank. The exosuit provides dorsiflexion assistance during swing phase for foot clearance and plantarflexion assistance during stance phase for propulsion delivered synchronously based on integrated sensors detecting the wearer's gait pattern. | Device | Exosuit Training |
| Propulsion neuroprosthesisA neuroprosthesis is a textile-based, surface electrical stimulation system worn on the waist and paretic lower limb that delivers stimulation assistance via electroconductive pads placed on the skin over the target muscles. The neuroprosthesis provides coordinated dorsiflexor stimulation during swing phase for foot clearance and plantarflexor stimulation during stance phase for propulsion, delivered synchronously based on integrated sensors detecting the wearer's gait pattern. | Device | Neuroprosthesis Training |
Primary outcome
Unassisted Overground Comfortable Walking Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Unassisted Overground Fast Walking Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Unassisted Paretic Propulsion on Treadmill (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Paretic propulsion during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Energy Efficiency on Treadmill (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Energy efficiency during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
Unassisted Overground Comfortable Walking Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Unassisted Overground Fast Walking Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Unassisted Paretic Propulsion on Treadmill (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Paretic propulsion during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Energy Efficiency on Treadmill (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Energy efficiency during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
10 secondary outcomes
Unassisted Overground Paretic Propulsion at Comfortable Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Fast Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Trailing Limb Angle on Treadmill (Exosuit Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Comfortable Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Propulsion at Fast Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Unassisted Paretic Trailing Limb Angle on Treadmill (Neuroprosthesis Day)
Time frame: Periprocedural (Before); Periprocedural (After)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- BackgroundAwad LN, Bae J, O'Donnell K, et al. Soft exosuits increase walking speed and distance after stroke. In: International Symposium on Wearable Robotics and Rehabilitation (WeRob). Houston, TX: IEEE; 2; 2017.
- Background: PubMed 28777105Awad LN, Bae J, Kudzia P, Long A, Hendron K, Holt KG, O'Donnell K, Ellis TD, Walsh CJ. Reducing Circumduction and Hip Hiking During Hemiparetic Walking Through Targeted Assistance of the Paretic Limb Using a Soft Robotic Exosuit. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S157-S164. doi: 10.1097/PHM.0000000000000800.
- Background: PubMed 28747517Awad LN, Bae J, O'Donnell K, De Rossi SMM, Hendron K, Sloot LH, Kudzia P, Allen S, Holt KG, Ellis TD, Walsh CJ. A soft robotic exosuit improves walking in patients after stroke. Sci Transl Med. 2017 Jul 26;9(400):eaai9084. doi: 10.1126/scitranslmed.aai9084.
- Background: PubMed 29361587Bae J, Awad LN, Long A, O'Donnell K, Hendron K, Holt KG, Ellis TD, Walsh CJ. Biomechanical mechanisms underlying exosuit-induced improvements in walking economy after stroke. J Exp Biol. 2018 Mar 7;221(Pt 5):jeb168815. doi: 10.1242/jeb.168815.
- Background: PubMed 30595090Ardestani MM, Kinnaird CR, Henderson CE, Hornby TG. Compensation or Recovery? Altered Kinetics and Neuromuscular Synergies Following High-Intensity Stepping Training Poststroke. Neurorehabil Neural Repair. 2019 Jan;33(1):47-58. doi: 10.1177/1545968318817825. Epub 2018 Dec 29.
- Background: PubMed 12610841Paci M. Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies. J Rehabil Med. 2003 Jan;35(1):2-7. doi: 10.1080/16501970306106.
- Background: PubMed 30408710Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.
- 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.
- BackgroundBae J, Siviy C, Rouleau M, et al. A lightweight and efficient portable soft exosuit for paretic ankle assistance in walking after stroke. Proc - IEEE Int Conf Robot Autom. 2018:2820-2827. doi:10.1109/ICRA.2018.8461046
- 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.
- BackgroundPorciuncula F, Arumukhom Revi D, Baker TC, et al. Speed-Based Gait Training with Soft Robotic Exosuits Improves Walking after Stroke: A Crossover Pilot Study. In: American Physical Therapy Association Combined Sections Meeting.; 2021.
- Background: PubMed 27819067Kesar 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Louis N Awad, PT, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft robotic exosuit and Propulsion neuroprosthesis 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 10 inclusion and 8 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 8 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 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?
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?
Unassisted Overground Comfortable Walking Speed (Exosuit Day) (time frame: Periprocedural (Before); Periprocedural (After)). The study lists 8 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 NCT07212608, which also lists 29 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 8 Oct 2025.