Personalized Post-Stroke Gait Rehabilitation Interventions
NCT ID: NCT07212608
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2022-09-13
2025-04-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
NCT07218094
Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
NCT06459401
Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
NCT05138016
Ankle Exoskeleton for Stroke Gait Enhancement
NCT07179627
Adaptive Hip Exoskeleton for Stroke Gait Enhancement
NCT05536739
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exosuit Training
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.
Soft robotic exosuit
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.
Neuroprosthesis Training
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.
Propulsion neuroprosthesis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Soft robotic exosuit
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 neuroprosthesis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Harvard University
OTHER
American Heart Association
OTHER
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Boston University Charles River Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lou Awad, PT, DPT, PhD
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Louis N Awad, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Awad 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.
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.
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.
Awad 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.
Bae 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.
Ardestani 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.
Paci 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.
Roelker 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.
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.
Bae 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.
Porciuncula 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.
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.
Reisman 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.
Koelewijn AD, Audu M, Del-Ama AJ, Colucci A, Font-Llagunes JM, Gogeascoechea A, Hnat SK, Makowski N, Moreno JC, Nandor M, Quinn R, Reichenbach M, Reyes RD, Sartori M, Soekadar S, Triolo RJ, Vermehren M, Wenger C, Yavuz US, Fey D, Beckerle P. Adaptation Strategies for Personalized Gait Neuroprosthetics. Front Neurorobot. 2021 Dec 16;15:750519. doi: 10.3389/fnbot.2021.750519. eCollection 2021.
Bajd T, Munih M. VI.2. Basic functional electrical stimulation (FES) of extremites - an engineer's view. Stud Health Technol Inform. 2010;152:343-52.
Embrey DG, Holtz SL, Alon G, Brandsma BA, McCoy SW. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010 May;91(5):687-96. doi: 10.1016/j.apmr.2009.12.024.
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.
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.
Awad LN, Reisman DS, Pohlig RT, Binder-Macleod SA. Reducing The Cost of Transport and Increasing Walking Distance After Stroke: A Randomized Controlled Trial on Fast Locomotor Training Combined With Functional Electrical Stimulation. Neurorehabil Neural Repair. 2016 Aug;30(7):661-70. doi: 10.1177/1545968315619696. Epub 2015 Nov 30.
Reisman DS, Binder-MacLeod S, Farquhar WB. Changes in metabolic cost of transport following locomotor training poststroke. Top Stroke Rehabil. 2013 Mar-Apr;20(2):161-70. doi: 10.1310/tsr2002-161.
Clark DJ, Ting LH, Zajac FE, Neptune RR, Kautz SA. Merging of healthy motor modules predicts reduced locomotor performance and muscle coordination complexity post-stroke. J Neurophysiol. 2010 Feb;103(2):844-57. doi: 10.1152/jn.00825.2009. Epub 2009 Dec 9.
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.
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.
Collimore AN, Pohlig RT, Awad LN. Minimal viable muscle set for identifying impairments in the neuromuscular control of walking using the dynamic motor control index. In: North American Congress on Biomechanics. Ottawa, CA. 2022.
Collimore AN, Aiello AJM, Pohlig RT, Awad LN. The dynamic motor control index is a better marker of age-related neuromotor impairments than the number of muscle synergies: Toward early detection of walking deficits. Neural Control of Movement Annual Meeting. Virtual. 2021.
Choe DK, Aiello AJ, Spangler JE, Walsh CJ, Awad LN. A Propulsion Neuroprosthesis Improves Overground Walking in Community-Dwelling Individuals After Stroke. IEEE Open J Eng Med Biol. 2024 Jul 4;5:563-572. doi: 10.1109/OJEMB.2024.3416028. eCollection 2024.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
830019
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
5715-FEX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.