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Suspended NCT06099444

Muscle Coordination-Based Feedback for Stroke Rehabilitation

Conditions: Stroke

Sex: All
Ages: 18 Years – 18 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: Shirley Ryan AbilityLab

Location: Shirley Ryan AbilityLab Chicago Illinois

Summary

The purpose of this study is to compare two interventions currently used to improve gait and lower limb function in individuals with chronic stroke (i.e., high-intensity gait training and high-intensity gait training with functional electrical stimulation (FES)) with novel interventions based on the coordinated activity of multiple muscles, known as muscle synergies. To this end, the researchers will recruit chronic stroke patients to participate in training protocols according to the currently used rehabilitation programs as well as novel rehabilitation programs that provide real time feedback of muscle synergies using multichannel FES and visual feedback.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06099444). StuddyBuddy aggregates publicly available trial information.