Personalized Post-Stroke Gait Rehabilitation Interventions

NCT07212608 | Completed FDA Device

• 3 other identifiers: 5715-FEXU54EB015408830019
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Keywords

Exosuit; Neuroprosthesis; Soft Robotics; Wearable Robots; Gait Rehabilitation; Propulsion; Functional Electrical Stimulation (FES); Stroke; Neuromuscular Control

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Periprocedural (Before); Periprocedural (After)

Secondary Outcomes (10)

• Unassisted Overground Paretic Propulsion at Comfortable Speed (Exosuit Day)

  Periprocedural (Before); Periprocedural (After)

• Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Exosuit Day)

  Periprocedural (Before); Periprocedural (After)

• Unassisted Overground Paretic Propulsion at Fast Speed (Exosuit Day)

  Periprocedural (Before); Periprocedural (After)

• Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Exosuit Day)

  Periprocedural (Before); Periprocedural (After)

• Unassisted Paretic Trailing Limb Angle on Treadmill (Exosuit Day)

  Periprocedural (Before); Periprocedural (After)

Other Outcomes (4)

• Stroke Chronicity

  Baseline (Day 1)

• Six-Minute Walk Test Distance

  Baseline (Day 1)

• Fugl-Meyer Assessment of Motor Recovery After Stroke

  Baseline (Day 1)

Study Arms (2)

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.

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.

Device: Propulsion neuroprosthesis

Interventions

Soft robotic exosuit DEVICE

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.

Exosuit Training

Propulsion neuroprosthesis DEVICE

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.

Neuroprosthesis Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Harvard University: collaborator
• American Heart Association: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (29)

• 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.

  BACKGROUND

• 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.

  PMID: 28777105 BACKGROUND

• 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.

  PMID: 28747517 BACKGROUND

• 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.

  PMID: 29361587 BACKGROUND

• 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.

  PMID: 30595090 BACKGROUND

• 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.

  PMID: 12610841 BACKGROUND

• 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.

  PMID: 30408710 BACKGROUND

• 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.

  PMID: 16456121 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33748765 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27819067 BACKGROUND

• 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.

  PMID: 27663199 BACKGROUND

• 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.

  PMID: 24189337 BACKGROUND

• 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.

  PMID: 22796242 BACKGROUND

• 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.

  PMID: 20692180 BACKGROUND

• 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.

  PMID: 34975445 BACKGROUND

• 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.

  PMID: 20407203 BACKGROUND

• 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.

  PMID: 20434604 BACKGROUND

• 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.

  PMID: 19834018 BACKGROUND

• 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.

  PMID: 28339828 BACKGROUND

• 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.

  PMID: 26621366 BACKGROUND

• 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.

  PMID: 23611857 BACKGROUND

• 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.

  PMID: 20007501 BACKGROUND

• 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.

  PMID: 26084733 BACKGROUND

• 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.

  PMID: 34366824 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39157060 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Louis N Awad, PT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: October 8, 2025
• Study Start: September 13, 2022
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)