StrokeNCT05138016
Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
A study testing Soft exosuit and No Soft exosuit in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
High intensity exercise is known to improve a person's ability to learn new motor skills. The goal of this project is to evaluate if a robotic exosuit can help people who have had a stroke perform walking rehabilitation at higher intensities than they are able to without the exosuit. 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 exosuit and No Soft exosuit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2021to 17 Jan 2023
- 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 stroke
- Chronic phase of recovery (>6mo post-stroke) (self-report)
- 18-80 years old (self-report)
- Independent ambulation (with or without an assistive device) for at least two minutes (confirmed at secondary screening visit)
- Provide HIPAA Authorization to allow communication with the healthcare provider as needed during the study period
- Medical clearance by the participant's physician
Who cannot join
- Score of > 1 on question 1b and > 0 on question 1c on the NIH Stroke Scale (NIHSS)
- Inability to communicate
- Unexplained dizziness in the last 6 months
- Serious comorbidities that may interfere with the ability to participate in this research (for example: musculoskeletal, cardiovascular, pulmonary, and neurological - other than stroke)
- Anemia (defined as hemoglobin levels of <13 g/dL for men and <12 g/dL for women)
- Clotting disorders**
Show all 17Show fewer
- Have given blood to any other entity within 60 days prior to blood collection
- History of significant Peripheral Artery Disease (PAD)
- Unresolved Deep Vein Thrombosis (DVT)
- Uncontrolled or untreated hypertension
- Significant paretic ankle contractures (plantarflexion > 5°)
- Psychiatric or cognitive impairments that may interfere with the proper operation of the device
- Presence of open wounds or broken skin at device locations requiring medical management
- Known urethane allergies
- Pregnancy
- Note: If the study team suspects neglect or hemianopia at any time during the course of the research, the physical therapist may administer the Star Cancellation Test (https://www.strokengine.ca/en/assess/sct/) for neglect or a visual field test (e.g., showing visual stimuli on different sides of the body) for hemianopia.
- Note: We may enroll participants who do not have a clotting disorder, but who are on anti-clotting medications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Boston, Massachusetts, 02215
Spaulding Rehabiliation Hospital
Charlestown, Massachusetts, 02129
About this study
High intensity exercise is known to improve a person's ability to learn new motor skills. The goal of this project is to evaluate if a robotic exosuit can help people who have had a stroke perform walking rehabilitation at higher intensities than they are able to without the exosuit. The investigators will measure exercise training intensity, biomarkers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF), and motor learning when people poststroke exercise with and without the exosuit. For this protocol, exosuits developed in collaboration with ReWalk™ Robotics will be used.
Aim 1: Determine the effects of a soft robotic exosuit on gait training intensity and serum BDNF in persons post-stroke completing a single bout of high intensity walking.
Read more
Hypothesis 1: Exosuits will allow individuals post-stroke to (i) walk at higher intensities or (ii) walk at a high intensity for longer durations.
Hypothesis 2: Training at a higher intensity, or training at high intensity for longer durations, will result in increased serum BDNF.
Aim 2: Determine the effects of a soft robotic exosuit on gait biomechanics measured after a single bout of high intensity walking with versus without a soft robotic exosuit.
Hypothesis 3: A single bout of high intensity walking with an exosuit will lead to demonstrably better gait biomechanics than a single bout of high intensity exercise without an exosuit.
Read the detailed description
Prior studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for impaired paretic limb function during walking. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce post-training improvements in gait quality. Indeed, current rehabilitation efforts are focused on either quality or intensity. They focus on gait quality by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without regard for the quality of their movements. The investigators posit that exosuits can uniquely enable high intensity gait training that promotes quality of movements.
Acute bouts of high intensity exercise prior to skilled task practice have been shown to enhance motor learning in neurologically intact individuals. However, the impact of high intensity exercise on motor learning in clinical populations remains largely unknown. A major limitation to studying this relationship in survivors of stroke are challenges in achieving and maintaining high intensity exercise levels (>75% max HR) during gait training for durations that are comparable to neurologically intact individuals. Exercising at a lower intensity or for a shorter duration may result in insufficient neurological "priming" for motor learning that typically follows high intensity training-which would be evidenced in reduced production of activity-dependent markers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF). For this study, the investigators will use standardized, maximal effort tests to evaluate the ability of a soft robotic exosuit to increase a patient's capacity for high intensity gait training. The investigators will also examine the resulting effect on BDNF and the relationship between training intensity, BDNF and motor learning measures.
- Conditions
- Stroke
- Being tested
- Soft exosuit, No Soft exosuit
- Keywords
- Neuroplasticity, Motor Learning, Exercise, Soft Robotics
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft exosuitDevice
Progressive cardiovascular exercise testing with soft exosuit assistance.
No Soft exosuitBehavioural
Progressive cardiovascular exercise testing.
| Study group | Role | What they receive |
|---|---|---|
| Exercise testing with soft exosuit assistance | Experimental | Progressive cardiovascular exercise testing on a treadmill with soft exosuit assistance. Receives: Device: Soft exosuit |
| Exercise testing without soft exosuit assistance | Active comparator | Progressive cardiovascular exercise testing on a treadmill. Receives: Behavioral: No Soft exosuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2-Peak
Average peak oxygen consumption rate.
Measured: Last 30 seconds of maximal effort exercise test.
Duration of high intensity exercise
Seconds spent exercising at greater than or equal to 76% age-predicted heart rate maximum value.
Measured: From the beginning to the end of the test, as determined based on standardized test termination criteria (e.g., volitional fatigue, cardiovascular abnormalities, or physical safety)
Concentration of brain-derived neurotrophic factor (BDNF)
A neurotrophic factor that is essential for learning and memory.
Measured: Baseline.
Concentration of brain-derived neurotrophic factor (BDNF)
A neurotrophic factor that is essential for learning and memory.
Measured: Immediately after maximal effort exercise test.
Forward Propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Measured: Baseline.
Forward Propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Measured: Immediately after maximal effort exercise test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start21 Jul 2021
- Primary completion28 Aug 2022
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject design
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Harvard University, Spaulding Rehabilitation Hospital
- Responsible party
- Sponsor
- Investigators
- Anna Roto, MS, MPH, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138016
- Sponsor's protocol ID
- 4977
- Status last verified
- Jul 2023
- First submitted
- 16 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 28747517Awad 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 33748765Bathina S, Das UN. Brain-derived neurotrophic factor and its clinical implications. Arch Med Sci. 2015 Dec 10;11(6):1164-78. doi: 10.5114/aoms.2015.56342. Epub 2015 Dec 11.
PubMed 26788077Charalambous CC, Helm EE, Lau KA, Morton SM, Reisman DS. The feasibility of an acute high-intensity exercise bout to promote locomotor learning after stroke. Top Stroke Rehabil. 2018 Mar;25(2):83-89. doi: 10.1080/10749357.2017.1399527. Epub 2017 Nov 5.
PubMed 29105605Crozier J, Roig M, Eng JJ, MacKay-Lyons M, Fung J, Ploughman M, Bailey DM, Sweet SN, Giacomantonio N, Thiel A, Trivino M, Tang A. High-Intensity Interval Training After Stroke: An Opportunity to Promote Functional Recovery, Cardiovascular Health, and Neuroplasticity. Neurorehabil Neural Repair. 2018 Jun;32(6-7):543-556. doi: 10.1177/1545968318766663. Epub 2018 Apr 20.
PubMed 29676956Dinoff A, Herrmann N, Swardfager W, Lanctot KL. The effect of acute exercise on blood concentrations of brain-derived neurotrophic factor in healthy adults: a meta-analysis. Eur J Neurosci. 2017 Jul;46(1):1635-1646. doi: 10.1111/ejn.13603. Epub 2017 Jun 19.
PubMed 28493624Ferris LT, Williams JS, Shen CL. The effect of acute exercise on serum brain-derived neurotrophic factor levels and cognitive function. Med Sci Sports Exerc. 2007 Apr;39(4):728-34. doi: 10.1249/mss.0b013e31802f04c7.
PubMed 17414812Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
PubMed 23877260Leech KA, Hornby TG. High-Intensity Locomotor Exercise Increases Brain-Derived Neurotrophic Factor in Individuals with Incomplete Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1240-1248. doi: 10.1089/neu.2016.4532. Epub 2017 Jan 18.
PubMed 27526567Mackay CP, Kuys SS, Brauer SG. The Effect of Aerobic Exercise on Brain-Derived Neurotrophic Factor in People with Neurological Disorders: A Systematic Review and Meta-Analysis. Neural Plast. 2017;2017:4716197. doi: 10.1155/2017/4716197. Epub 2017 Sep 19.
PubMed 29057125Nepveu JF, Thiel A, Tang A, Fung J, Lundbye-Jensen J, Boyd LA, Roig M. A Single Bout of High-Intensity Interval Training Improves Motor Skill Retention in Individuals With Stroke. Neurorehabil Neural Repair. 2017 Aug;31(8):726-735. doi: 10.1177/1545968317718269. Epub 2017 Jul 8.
PubMed 28691645Roig M, Skriver K, Lundbye-Jensen J, Kiens B, Nielsen JB. A single bout of exercise improves motor memory. PLoS One. 2012;7(9):e44594. doi: 10.1371/journal.pone.0044594. Epub 2012 Sep 4.
PubMed 22973462Skriver K, Roig M, Lundbye-Jensen J, Pingel J, Helge JW, Kiens B, Nielsen JB. Acute exercise improves motor memory: exploring potential biomarkers. Neurobiol Learn Mem. 2014 Dec;116:46-58. doi: 10.1016/j.nlm.2014.08.004. Epub 2014 Aug 14.
PubMed 25128877Snow NJ, Mang CS, Roig M, McDonnell MN, Campbell KL, Boyd LA. The Effect of an Acute Bout of Moderate-Intensity Aerobic Exercise on Motor Learning of a Continuous Tracking Task. PLoS One. 2016 Feb 22;11(2):e0150039. doi: 10.1371/journal.pone.0150039. eCollection 2016.
PubMed 26901664
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
- ClinicalTrials.gov ID
- NCT05138016
- Acronym / sponsor ID
- 4977
- Conditions
- Stroke
- Keywords
- Neuroplasticity, Motor Learning, Exercise, Soft Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- American Heart Association, Harvard University, Spaulding Rehabilitation Hospital
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 30 Nov 2021 (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.
High intensity exercise is known to improve a person's ability to learn new motor skills. The goal of this project is to evaluate if a robotic exosuit can help people who have had a stroke perform walking rehabilitation at higher intensities than they are able to without the exosuit. The investigators will measure exercise training intensity, biomarkers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF), and motor learning when people poststroke exercise with and without the exosuit. For this protocol, exosuits developed in collaboration with ReWalk™ Robotics will be used.
Aim 1: Determine the effects of a soft robotic exosuit on gait training intensity and serum BDNF in persons post-stroke completing a single bout of high intensity walking.
Hypothesis 1: Exosuits will allow individuals post-stroke to (i) walk at higher intensities or (ii) walk at a high intensity for longer durations.
Hypothesis 2: Training at a higher intensity, or training at high intensity for longer durations, will result in increased serum BDNF.
Aim 2: Determine the effects of a soft robotic exosuit on gait biomechanics measured after a single bout of high intensity walking with versus without a soft robotic exosuit.
Hypothesis 3: A single bout of high intensity walking with an exosuit will lead to demonstrably better gait biomechanics than a single bout of high intensity exercise without an exosuit.
Detailed description
Prior studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for impaired paretic limb function during walking. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce post-training improvements in gait quality. Indeed, current rehabilitation efforts are focused on either quality or intensity. They focus on gait quality by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without regard for the quality of their movements. The investigators posit that exosuits can uniquely enable high intensity gait training that promotes quality of movements.
Acute bouts of high intensity exercise prior to skilled task practice have been shown to enhance motor learning in neurologically intact individuals. However, the impact of high intensity exercise on motor learning in clinical populations remains largely unknown. A major limitation to studying this relationship in survivors of stroke are challenges in achieving and maintaining high intensity exercise levels (>75% max HR) during gait training for durations that are comparable to neurologically intact individuals. Exercising at a lower intensity or for a shorter duration may result in insufficient neurological "priming" for motor learning that typically follows high intensity training-which would be evidenced in reduced production of activity-dependent markers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF). For this study, the investigators will use standardized, maximal effort tests to evaluate the ability of a soft robotic exosuit to increase a patient's capacity for high intensity gait training. The investigators will also examine the resulting effect on BDNF and the relationship between training intensity, BDNF and motor learning measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-subject design
| Arm | Type | Receives |
|---|---|---|
| Exercise testing with soft exosuit assistance | Experimental | Device: Soft exosuitProgressive cardiovascular exercise testing on a treadmill with soft exosuit assistance. |
| Exercise testing without soft exosuit assistance | Active comparator | Behavioral: No Soft exosuitProgressive cardiovascular exercise testing on a treadmill. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke
- Chronic phase of recovery (>6mo post-stroke) (self-report)
- 18-80 years old (self-report)
- Independent ambulation (with or without an assistive device) for at least two minutes (confirmed at secondary screening visit)
- Provide HIPAA Authorization to allow communication with the healthcare provider as needed during the study period
Key exclusion criteria (17 listed)
- Score of > 1 on question 1b and > 0 on question 1c on the NIH Stroke Scale (NIHSS)
- Inability to communicate
- Unexplained dizziness in the last 6 months
- Serious comorbidities that may interfere with the ability to participate in this research (for example: musculoskeletal, cardiovascular, pulmonary, and neurological - other than stroke)
- Anemia (defined as hemoglobin levels of <13 g/dL for men and <12 g/dL for women)
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 exosuitProgressive cardiovascular exercise testing with soft exosuit assistance. | Device | Exercise testing with soft exosuit assistance |
| No Soft exosuitProgressive cardiovascular exercise testing. | Behavioural | Exercise testing without soft exosuit assistance |
Primary outcome
VO2-Peak
Time frame: Last 30 seconds of maximal effort exercise test.
Average peak oxygen consumption rate.
Duration of high intensity exercise
Time frame: From the beginning to the end of the test, as determined based on standardized test termination criteria (e.g., volitional fatigue, cardiovascular abnormalities, or physical safety)
Seconds spent exercising at greater than or equal to 76% age-predicted heart rate maximum value.
Concentration of brain-derived neurotrophic factor (BDNF)
Time frame: Baseline.
A neurotrophic factor that is essential for learning and memory.
Concentration of brain-derived neurotrophic factor (BDNF)
Time frame: Immediately after maximal effort exercise test.
A neurotrophic factor that is essential for learning and memory.
Forward Propulsion
Time frame: Baseline.
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Forward Propulsion
Time frame: Immediately after maximal effort exercise test.
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
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 1 Aug 2023.
- 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 33748765Awad LN, Kudzia P, Revi DA, Ellis TD, Walsh CJ. Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. IEEE Open J Eng Med Biol. 2020;1:108-115. doi: 10.1109/ojemb.2020.2984429. Epub 2020 Apr 2.
- Background: PubMed 26788077Bathina S, Das UN. Brain-derived neurotrophic factor and its clinical implications. Arch Med Sci. 2015 Dec 10;11(6):1164-78. doi: 10.5114/aoms.2015.56342. Epub 2015 Dec 11.
- Background: PubMed 29105605Charalambous CC, Helm EE, Lau KA, Morton SM, Reisman DS. The feasibility of an acute high-intensity exercise bout to promote locomotor learning after stroke. Top Stroke Rehabil. 2018 Mar;25(2):83-89. doi: 10.1080/10749357.2017.1399527. Epub 2017 Nov 5.
- Background: PubMed 29676956Crozier J, Roig M, Eng JJ, MacKay-Lyons M, Fung J, Ploughman M, Bailey DM, Sweet SN, Giacomantonio N, Thiel A, Trivino M, Tang A. High-Intensity Interval Training After Stroke: An Opportunity to Promote Functional Recovery, Cardiovascular Health, and Neuroplasticity. Neurorehabil Neural Repair. 2018 Jun;32(6-7):543-556. doi: 10.1177/1545968318766663. Epub 2018 Apr 20.
- Background: PubMed 28493624Dinoff A, Herrmann N, Swardfager W, Lanctot KL. The effect of acute exercise on blood concentrations of brain-derived neurotrophic factor in healthy adults: a meta-analysis. Eur J Neurosci. 2017 Jul;46(1):1635-1646. doi: 10.1111/ejn.13603. Epub 2017 Jun 19.
- Background: PubMed 17414812Ferris LT, Williams JS, Shen CL. The effect of acute exercise on serum brain-derived neurotrophic factor levels and cognitive function. Med Sci Sports Exerc. 2007 Apr;39(4):728-34. doi: 10.1249/mss.0b013e31802f04c7.
- Background: PubMed 23877260Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
- Background: PubMed 27526567Leech KA, Hornby TG. High-Intensity Locomotor Exercise Increases Brain-Derived Neurotrophic Factor in Individuals with Incomplete Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1240-1248. doi: 10.1089/neu.2016.4532. Epub 2017 Jan 18.
- Background: PubMed 29057125Mackay CP, Kuys SS, Brauer SG. The Effect of Aerobic Exercise on Brain-Derived Neurotrophic Factor in People with Neurological Disorders: A Systematic Review and Meta-Analysis. Neural Plast. 2017;2017:4716197. doi: 10.1155/2017/4716197. Epub 2017 Sep 19.
- Background: PubMed 28691645Nepveu JF, Thiel A, Tang A, Fung J, Lundbye-Jensen J, Boyd LA, Roig M. A Single Bout of High-Intensity Interval Training Improves Motor Skill Retention in Individuals With Stroke. Neurorehabil Neural Repair. 2017 Aug;31(8):726-735. doi: 10.1177/1545968317718269. Epub 2017 Jul 8.
- 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.
Anna Roto, MS, MPH study director
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft exosuit and No Soft exosuit in people with Stroke, run by Boston University Charles River Campus at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
VO2-Peak (time frame: Last 30 seconds of maximal effort exercise test.). The study lists 6 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 NCT05138016, which also lists 20 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 1 Aug 2023.