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

About this trial
This is an interventional basic science trial for Stroke focused on measuring Neuroplasticity, Motor Learning, Exercise, Soft Robotics
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.
Sites / Locations
- Boston University
- Spaulding Rehabiliation Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Exercise testing with soft exosuit assistance
Exercise testing without soft exosuit assistance
Progressive cardiovascular exercise testing on a treadmill with soft exosuit assistance.
Progressive cardiovascular exercise testing on a treadmill.