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| ID | Type | Description | Link |
|---|---|---|---|
| U54EB015408 | U.S. NIH Grant/Contract | View source | |
| 830019 | Other Grant/Funding Number | American Heart Association Pre-Doctoral Fellowship |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| American Heart Association | OTHER |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Periprocedural (Before); Periprocedural (After) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Chronicity | Length of time since onset of stroke. | Baseline (Day 1) |
| Six-Minute Walk Test Distance | Distance walked during the Six-Minute Walk Test (6MWT), a clinical assessment measuring walking endurance. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis N Awad, PT, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Neuromotor Recovery Laboratory | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 28777105 | 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. | |
| 28747517 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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. |
|
| 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) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Periprocedural (Before); Periprocedural (After) |
| Baseline (Day 1) |
| Fugl-Meyer Assessment of Motor Recovery After Stroke | Score on the Fugl-Meyer Assessment - Lower Extremity (FMA-LE). The FMA-LE includes a series of short activities that are assessed by a physical therapist to evaluate post-stroke recovery. | Baseline (Day 1) |
| Plantarflexor Central Drive | Plantarflexor central drive captures the percentage of the plantarflexor muscle's total force-generating capacity that can be voluntarily controlled by an individual with a neurological injury. Central drive is calculated as the ratio of the maximum voluntary isometric contraction (MVIC) to the maximum force generating ability (MFGA). | Baseline (Day 1) |
| 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. |
| 29361587 | 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. |
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| 30408710 | 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. |
| 16456121 | 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. |
| 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 |
| 33748765 | 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. |
| 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. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |