Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05138016
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-08-16
Brief Title:
Effects of Soft Robotic Exosuit on Exercise Capacity Biomakers of Neuroplasticity and Motor Learning After Stroke
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Effects of Soft Robotic Exosuit on Exercise Capacity Biomakers of Neuroplasticity and Motor Learning After Stroke
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High intensity exercise is known to improve a persons 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 eg 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
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 exosuits 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 eg 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 patients 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
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 eg 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None