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

100 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Muscle Coordination-Based Feedback for stroke rehabilitation?

Research shows that feedback, such as vibratory or position feedback, can improve motor learning and movement performance in stroke rehabilitation. Additionally, robotic rehabilitation, which involves feedback and muscle coordination, has shown promising results in improving arm function and motor control in stroke survivors. ^{1 2 3 4 5}

Is the Muscle Coordination Feedback + Electrical Stimulation treatment safe for humans?

Preliminary data from a case study with a stroke survivor suggest that using a muscle biofeedback system for 10 weeks is safe and enjoyable, indicating that this approach is generally safe for humans. ^{6 7 8 9 10}

How does the treatment 'Muscle Coordination Feedback + Electrical Stimulation for Stroke Rehabilitation' differ from other treatments for stroke rehabilitation?

This treatment is unique because it combines muscle coordination feedback with electrical stimulation to enhance stroke rehabilitation. Unlike traditional therapies, it uses real-time feedback on muscle activity and joint movement to improve motor control and gait, potentially offering more precise and effective rehabilitation. ^{1 2 11 12 13}

Research Team

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Practice Variability Combined with Task-Oriented Electromyographic Biofeedback Enhances Strength and Balance in People with Chronic Stroke. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Accelerometers and force sensing resistors for optimal control of walking of a hemiplegic. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Motor task performance under vibratory feedback early poststroke: single center, randomized, cross-over, controlled clinical trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on the effects induced by robot-assisted and usual-care rehabilitation on upper limb muscle synergies in post-stroke subjects. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Low-Cost, Modular Muscle-Computer Interface for At-Home Telerehabilitation for Chronic Stroke. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cyclical electrical stimulation increases strength and improves activity after stroke: a systematic review. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Eccentric versus concentric resistance training to enhance neuromuscular activation and walking speed following stroke. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Electrostimulation for promoting recovery of movement or functional ability after stroke. [2022]

10. England 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. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Feedback of ankle joint angle and soleus electromyography in the rehabilitation of hemiplegic gait. [2019]

12. United States 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. [2022]

13. United States 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. [2021]