Trial Summary
What is the purpose of this trial?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
This trial is for individuals aged 18-80 who have had a single unilateral stroke at least six months ago and can walk over 10 meters with or without an assistive device. They must be able to understand English, give consent, and have normal hearing and vision (correctable). Excluded are those with severe cognitive issues, aphasia, major medical conditions that could interfere with the study, pregnancy, prisoners, metallic/electrical implants in the body or significant spasticity in lower limbs.Inclusion Criteria
I am between 18 and 80 years old.
I am between 18 and 80 years old.
My hearing and vision are normal or corrected to normal.
My hearing and vision are normal or corrected to normal.
I understand the study and agree to participate.
I can understand and speak English.
I can move all my joints normally.
Exclusion Criteria
I am healthy but have trouble with memory or understanding tasks.
I am healthy but have wounds or lesions on my legs.
I do not have any health conditions that would affect my participation in the study.
I do not have any health conditions that would affect my participation in the study.
I have sores or wounds on my leg that has reduced strength.
I have not had Botox injections in my legs in the last 3 months and do not plan to during the study.
I do not have any neurological disorders or history of neurological injuries.
I do not have conditions like epilepsy or severe arthritis affecting my movement.
I struggle with thinking clearly or doing tasks for a study.
I have severe arthritis in my hip, knee, or ankle.
I do not have other neurological conditions like Parkinson's, dementia, or brain injuries.
I am a therapist who hasn't completed 1 competency session or delivered 6 intervention sessions.
Treatment Details
The study compares traditional high-intensity gait training and gait training using functional electrical stimulation (FES) against new methods providing real-time feedback on muscle coordination. Participants will receive either standard FES to the Tibialis Anterior muscle or Synergy-Based Multichannel FES combined with visual biofeedback based on muscle synergies.
5Treatment groups
Experimental Treatment
Active Control
Group I: Synergy-Based Multichannel FES (MFES)Experimental Treatment1 Intervention
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.
Group II: Synergy-Based Multichannel (MFES) + Muscle Synergy Visual BiofeedbackExperimental Treatment2 Interventions
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.
Group III: Standard FES to the Tibialis Anterior (TA)Experimental Treatment1 Intervention
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).
Group IV: Muscle Synergy Visual BiofeedbackExperimental Treatment1 Intervention
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.
Group V: Conventional High Intensity Gait TrainingActive Control1 Intervention
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Shirley Ryan AbilityLabChicago, IL
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor