Muscle Coordination-Based Feedback for Stroke Rehabilitation
Stroke
About this trial
This is an interventional basic science trial for Stroke focused on measuring Stroke, Functional Electrical Stimulation (FES), Gait Rehabilitation, Stroke Rehabilitation, Muscle Synergies
Eligibility Criteria
Healthy participants: Inclusion Criteria: Age 18-80 years, inclusive Normal hearing and vision, can be corrected Able to understand and give informed consent Able to understand and speak English Exclusion Criteria: Reduced cognitive function or inability to perform study tasks Any neurological disorder or history of neurological injuries (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, peripheral nerve injury, or cancer of the central nervous system) Presence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, marked arthritis, chronic pain, musculoskeletal injuries) Recent fracture or osteoporosis (as reported by subject) Lesions or wounds on the legs Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures Pregnancy Prisoners Patients: Inclusion Criteria: Age 18-80 years, inclusive Normal hearing and vision, can be corrected History of a single unilateral, supratentorial ischemic or hemorrhagic stroke at least six months prior Reduced ambulation but able to walk >10m independently on level ground (with assistive device if needed) Medical clearance from medical team (signed Medical Clearance form) Able to understand and give informed consent Able to understand and speak English Able to passively move all joints (i.e., hip, knee, ankle) through the range of motion of a typical gait cycle Exclusion Criteria: Reduced cognitive function and inability to perform study tasks Severe aphasia Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system) History of peripheral nerve injury Severe hip, knee, or ankle arthritis Recent fracture or osteoporosis (as reported by subject) Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures Significant spasticity or contracture in the lower limbs (Modified Ashworth Scale score of 3 or higher) Use of pacemakers, defibrillators, electrical implants, or metallic implants Lesions or wounds on the paretic leg Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period Pregnancy Prisoners Concurrent or planned participation in surgeries, significant medical treatments, other lower limb research studies, or physical therapy during the study timeline Therapists: Inclusion Criteria: Licensed physical therapist at SRALab At least 1 year of experience as a physical therapist Regularly treats people with stroke, at minimum once per week Able to give informed consent Active CITI training certification, or willing to complete this online CITI training Exclusion Criteria: Inability to interact safety with the technologies Unwillingness to try to use the technologies Unable to complete at least 1 competency session and deliver at least 6 intervention sessions
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Conventional High Intensity Gait Training
Standard FES to the Tibialis Anterior (TA)
Synergy-Based Multichannel FES (MFES)
Muscle Synergy Visual Biofeedback
Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback
Participants in the conventional high-intensity gait training group will undergo gait training on a treadmill. Each session will consist of between 30-60 minutes of walking targeted to reach a high intensity, as measured via heart rate and Borg rating of perceived exertion. This may also include inclined walking, walking with an ankle weight, backwards walking, sidestepping, and/or obstacle walking.
Participants in the standard FES gait training group will receive FES applied to the TA muscle/peroneal nerve on his/her more affected leg. FES strategically stimulates the TA/peroneal nerve at specific phases of the gait cycle identified by internal inertial measurement units (IMUs).
Participants in the synergy-based MFES gait training group will receive FES applied to muscles of the affected lower limb. These muscles may include the TA, gastrocnemius medialis, gastrocnemius lateralis, soleus, rectus femoris, vastus medialis, vastus lateralis, semitendinosus, biceps femoris, gluteus medius, and adductor longus. FES will be applied to each muscle with an activation pattern that is derived from extracted healthy muscle synergies that are scaled to fit the patient's gait cycle.
Participants in the muscle synergy visual biofeedback group will wear bipolar EMG sensors on the muscles of interest. In real time, muscle synergies will be extracted and the similarity of affected synergies to healthy synergies will be displayed on a screen. Patients in this group will be instructed to try to increase the similarity score of the affected synergies and the healthy synergies. No electrical stimulation will be provided in this group.
Participants in the group will receive a combination of the synergy-based MFES and muscle synergy visual biofeedback interventions. Because EMG cannot be recorded while FES is being applied in a continuous fashion, this method will alternate between providing sensory feedback (FES) and visual feedback of the muscle synergies.