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Muscle Coordination Feedback + Electrical Stimulation for Stroke Rehabilitation

N/A

Waitlist Available

Led By Jose L Pons, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy participants: Age 18-80 years, inclusive

Patients: Age 18-80 years, inclusive

Must not have

Healthy participants: Reduced cognitive function or inability to perform study tasks

Healthy participants: Lesions or wounds on the legs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-assessment after 3 weeks of training, post-assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare current stroke rehab treatments to novel ones that use electrical stimulation and feedback to coordinate multiple muscles for improved gait and lower limb function.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation during FES therapy sessions. There might also be general fatigue due to high-intensity gait training exercises. The specific side effects of synergy-based interventions are not detailed but could involve similar experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I am between 18 and 80 years old.

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My hearing and vision are normal or corrected to normal.

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My hearing and vision are normal or corrected to normal.

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I understand the study and agree to participate.

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I can understand and speak English.

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I can move all my joints normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am healthy but have trouble with memory or understanding tasks.

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I am healthy but have wounds or lesions on my legs.

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I do not have any health conditions that would affect my participation in the study.

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I do not have any health conditions that would affect my participation in the study.

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I have sores or wounds on my leg that has reduced strength.

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I have not had Botox injections in my legs in the last 3 months and do not plan to during the study.

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I do not have any neurological disorders or history of neurological injuries.

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I do not have conditions like epilepsy or severe arthritis affecting my movement.

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I struggle with thinking clearly or doing tasks for a study.

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I have severe arthritis in my hip, knee, or ankle.

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I do not have other neurological conditions like Parkinson's, dementia, or brain injuries.

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I am a therapist who hasn't completed 1 competency session or delivered 6 intervention sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-assessment after 3 weeks of training, post-assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-assessment after 3 weeks of training, post-assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-assessment after 3 weeks of training, post-assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in muscle synergies during walking

Secondary study objectives

Change in "The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure"

Change in 10 Meter Walk Test

Change in 6 Minute Walk Test

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 19Eligibility criteria met