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Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soft exosuit
No Soft exosuit
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Neuroplasticity, Motor Learning, Exercise, Soft Robotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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**
  • 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.

Sites / Locations

  • Boston University
  • Spaulding Rehabiliation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise testing with soft exosuit assistance

Exercise testing without soft exosuit assistance

Arm Description

Progressive cardiovascular exercise testing on a treadmill with soft exosuit assistance.

Progressive cardiovascular exercise testing on a treadmill.

Outcomes

Primary Outcome Measures

VO2-Peak
Average peak oxygen consumption rate.
Duration of high intensity exercise
Seconds spent exercising at greater than or equal to 76% age-predicted heart rate maximum value.
Concentration of brain-derived neurotrophic factor (BDNF)
A neurotrophic factor that is essential for learning and memory.
Concentration of brain-derived neurotrophic factor (BDNF)
A neurotrophic factor that is essential for learning and memory.
Forward Propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Forward Propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
July 28, 2023
Sponsor
Boston University Charles River Campus
Collaborators
American Heart Association, Harvard University, Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05138016
Brief Title
Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
Official Title
Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
August 28, 2022 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
American Heart Association, Harvard University, Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Neuroplasticity, Motor Learning, Exercise, Soft Robotics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within-subject design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise testing with soft exosuit assistance
Arm Type
Experimental
Arm Description
Progressive cardiovascular exercise testing on a treadmill with soft exosuit assistance.
Arm Title
Exercise testing without soft exosuit assistance
Arm Type
Active Comparator
Arm Description
Progressive cardiovascular exercise testing on a treadmill.
Intervention Type
Device
Intervention Name(s)
Soft exosuit
Intervention Description
Progressive cardiovascular exercise testing with soft exosuit assistance.
Intervention Type
Behavioral
Intervention Name(s)
No Soft exosuit
Intervention Description
Progressive cardiovascular exercise testing.
Primary Outcome Measure Information:
Title
VO2-Peak
Description
Average peak oxygen consumption rate.
Time Frame
Last 30 seconds of maximal effort exercise test.
Title
Duration of high intensity exercise
Description
Seconds spent exercising at greater than or equal to 76% age-predicted heart rate maximum value.
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)
Title
Concentration of brain-derived neurotrophic factor (BDNF)
Description
A neurotrophic factor that is essential for learning and memory.
Time Frame
Baseline.
Title
Concentration of brain-derived neurotrophic factor (BDNF)
Description
A neurotrophic factor that is essential for learning and memory.
Time Frame
Immediately after maximal effort exercise test.
Title
Forward Propulsion
Description
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Time Frame
Baseline.
Title
Forward Propulsion
Description
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Time Frame
Immediately after maximal effort exercise test.
Other Pre-specified Outcome Measures:
Title
International Physical Activities Questionnaire
Description
A 27-item self-report questionnaire used to collect data on health-related physical activity.
Time Frame
Baseline.
Title
Number of Participants with Rs6265
Description
A single nucleotide polymorphism in the BDNF gene.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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** 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Roto, MS, MPH
Organizational Affiliation
Boston University
Official's Role
Study Director
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Spaulding Rehabiliation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke

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