Muscle Coordination Feedback + Electrical Stimulation for Stroke Rehabilitation

Overseen By Grace Hoo, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Neurological disorders, Severe arthritis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to improve walking and leg function in stroke survivors. Researchers compare traditional high-intensity walking exercises with treatments using electrical pulses and visual feedback to enhance muscle coordination. Participants will be divided into groups to try different therapy combinations. Ideal candidates are individuals who had a stroke over six months ago and can walk at least 10 meters independently, though they may use a cane or walker. As an unphased trial, this study provides participants the chance to explore innovative therapies that could enhance recovery and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the lower limbs within the last 3 months or plan to have one during the study, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that functional electrical stimulation (FES) is generally well-received in stroke rehabilitation. A review of 25 studies found that FES-based treatments positively affect stroke recovery, particularly in improving movement. However, some studies noted that FES did not significantly enhance certain aspects of walking, such as the distance covered in a 6-minute walk for some patients.

For synergy-based multichannel FES, studies indicate it effectively enhances motor coordination and walking in stroke patients. This method uses multiple channels to stimulate different muscles and is considered safe and beneficial. Research supports its use in stroke rehabilitation due to positive feedback on improving motor function.

Muscle synergy visual biofeedback, which provides real-time feedback on muscle activity, has been studied for its role in rehabilitation. Evidence suggests it helps patients improve movement by aligning muscle activity with healthy patterns. Studies indicate it is a safe method with no significant adverse events reported.

Overall, current research findings suggest these treatments are well-tolerated and safe for use in stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring Muscle Coordination Feedback and Electrical Stimulation for stroke rehabilitation because it introduces new ways to enhance motor recovery. Unlike traditional rehabilitation methods like physical therapy, which rely on repetitive physical exercises, this approach uses advanced electrical stimulation techniques to target specific muscle groups. The synergy-based multichannel FES (MFES) and muscle synergy visual biofeedback provide real-time feedback and stimulation, helping patients retrain their muscles more effectively. This combination aims to mimic natural muscle movements more closely, potentially leading to faster and more efficient recovery for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that functional electrical stimulation (FES) can help stroke patients improve their walking ability. In one study, all participants who received FES could walk after treatment, and 84.6% returned home, compared to 53.3% in a group without FES. In this trial, participants in the "Standard FES to the Tibialis Anterior (TA)" arm will receive FES applied to the TA muscle/peroneal nerve. A more advanced version, synergy-based multichannel FES (MFES), is being tested in the "Synergy-Based Multichannel FES (MFES)" arm and has shown promising results, with noticeable improvements in walking speed and distance. When combined with visual biofeedback, as in the "Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback" arm, MFES also enhances movement quality. Visual biofeedback alone, tested in the "Muscle Synergy Visual Biofeedback" arm, aids recovery by encouraging patients to adjust their muscle movements to healthier patterns. These findings suggest that these techniques could significantly aid stroke rehabilitation. ^{1 3 5 6 7}

Who Is on the Research Team?

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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

Patients: Medical clearance from medical team (signed Medical Clearance form)

Healthy participants: Able to understand and give informed consent

I am a therapist with current CITI training or willing to complete it.

Exclusion Criteria

Patients: Prisoners

Healthy participants: Pregnancy

Healthy participants: Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gait training using various interventions including high-intensity gait training, standard FES, and novel muscle synergy-based interventions

6 weeks

3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1-month follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Muscle Coordination-Based Feedback

Trial Overview

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.

How Is the Trial Designed?

Group I: Synergy-Based Multichannel FES (MFES) Experimental Treatment 1 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 Biofeedback Experimental Treatment 2 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 Treatment 1 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 Biofeedback Experimental Treatment 1 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 Training Active Control 1 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.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

The study involving 9 chronic stroke survivors showed that using a surface electromyography (sEMG) biofeedback system through a video game significantly improved muscle activation during wrist movements, indicating potential for enhancing motor control.

However, while there were positive changes in muscle activation, the intervention did not lead to significant improvements in overall movement quality or functional abilities, suggesting that adding more functional activities could enhance the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary investigation of an electromyography-controlled video game as a home program for persons in the chronic phase of stroke recovery. Donoso Brown, EV., McCoy, SW., Fechko, AS., et al.[2022]

The study demonstrated that using real-time feedback surface electromyography (sEMG) to control muscle activation is a reliable method for measuring motor evoked potentials (MEPs) in stroke patients, with high test-retest reliability for motor threshold and moderate reliability for MEP latency and amplitude.

Patients with detectable MEPs showed significantly better muscle power and functional scores compared to those without MEPs, indicating that sEMG-guided muscle activation can effectively assess recovery and may be useful for long-term monitoring in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using surface electromyography to guide the activation during motor-evoked potential measurement: An activation control method for follow-up studies. Lin, LF., Huang, YZ., Hu, CJ., et al.[2016]

Functional electrical stimulation (FES) combined with voluntary movement (FESVOL) enhances cerebellar activity and may improve rehabilitation outcomes for post-stroke hemiplegia, suggesting a synergistic effect between electrical stimulation and voluntary effort.

The study indicates that FESVOL leads to reduced activity in secondary somatosensory areas, which may reflect a more accurate internal model of movement, potentially improving the effectiveness of rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of electrical stimulation and voluntary hand movement in SII and the cerebellum during simulated therapeutic functional electrical stimulation in healthy adults. Iftime-Nielsen, SD., Christensen, MS., Vingborg, RJ., et al.[2021]

The Tele-REINVENT system, a low-cost telerehabilitation biofeedback tool, has been developed to help stroke survivors improve muscle control at home, showing feasibility and safety in a case study with one stroke patient over 40 sessions in 10 weeks.

Preliminary results indicate that the system can effectively train differentiated muscle activity and reduce unwanted co-contractions, suggesting it could be a valuable tool for personalized rehabilitation in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Low-Cost, Modular Muscle-Computer Interface for At-Home Telerehabilitation for Chronic Stroke. Marin-Pardo, O., Phanord, C., Donnelly, MR., et al.[2021]

In a pilot study with 5 chronic stroke patients, position feedback during upper limb reach training led to improvements in kinematic variables, indicating enhanced motor learning.

Subjects required only a small percentage (7.4% to 14.7%) of training time for position feedback, yet all showed increased movement performance, suggesting that immediate feedback on errors can effectively aid rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. Molier, BI., Prange, GB., Krabben, T., et al.[2019]

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