EMG-Controlled Device for Stroke Rehabilitation

Overseen By Holly B Henry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Hemorrhagic stroke, Seizures, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those currently taking medications that lower the threshold for seizures.

What data supports the effectiveness of the treatment MARK for stroke rehabilitation?

Research shows that using surface electromyography (EMG) to monitor muscle activity can help track recovery and improve rehabilitation for stroke patients. EMG feedback has been shown to enhance control and movement in stroke-affected limbs, suggesting that EMG-controlled devices like MARK could be effective in stroke rehabilitation. ^{1 2 3 4 5}

Is the EMG-Controlled Device for Stroke Rehabilitation safe for humans?

Research on similar technologies like surface electromyography (sEMG) and MIRA has shown that they are generally safe for use in humans, with no adverse events reported in studies. These technologies are non-invasive and have been used comfortably in clinical settings to monitor muscle activity and aid rehabilitation. ^{1 2 6 7 8}

How does the EMG-controlled device treatment for stroke rehabilitation differ from other treatments?

The EMG-controlled device for stroke rehabilitation is unique because it uses electromyography (EMG) signals, which are the electrical signals from muscle contractions, to control rehabilitation devices. This allows for personalized and real-time feedback, enabling stroke patients to engage in rehabilitation exercises at home without needing a therapist present, which is different from traditional rehabilitation methods that often require in-person supervision. ^{1 9 10 11 12}

Research Team

Ahlam Salameh, PhD MSc

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

This trial is for veterans over 18 who've had an ischemic stroke within the last 6 months, can understand English, and follow directions. They should be medically stable with a certain level of muscle stiffness in their arm but able to move it enough to wear a device. They must not have severe arm contractures, involuntary movements, or conditions that could interfere with the study.

Inclusion Criteria

I had a stroke caused by a clot between 2 days and 6 months ago.

You can consistently and intentionally produce detectable muscle signals in your upper and lower arm with your wrist in a normal or bent position, as detected by the Myopro software.

I can move my elbow, forearm, wrist, and hand well enough to wear a device.

Exclusion Criteria

My family has a history of epilepsy that doesn't respond well to medication.

I have had a stroke that affected my ability to move the opposite side of my body.

I can't lift my arm sideways or in front above shoulder level.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acute rehabilitation with an EMG controlled device for stroke survivors with severe arm deficit

6 weeks

Follow-up

Participants are monitored for changes in arm function and impairment after treatment

4 weeks

Treatment Details

Interventions

• MARK

Trial Overview The trial tests if using an EMG controlled device during early rehabilitation helps stroke survivors with severe arm deficits improve more than standard care alone. The goal is to see if this technology increases their ability to perform daily activities independently.

Participant Groups

Group I: Feasibility Experimental Treatment 1 Intervention

To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Using surface electromyography (EMG) in acute care for stroke survivors is feasible and can effectively monitor muscle activity, even in patients with no detectable movement through traditional assessments.

EMG has the potential to enhance recovery tracking and rehabilitation planning, but challenges such as the need for affordable, user-friendly technology and rapid data processing must be addressed to fully realize its benefits in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle Activity After Stroke: Perspectives on Deploying Surface Electromyography in Acute Care. Steele, KM., Papazian, C., Feldner, HA.[2020]

Stroke survivors recognize the potential of surface electromyography (sEMG) technology for aiding recovery, but they express a need for clearer interpretation of the data it provides to enhance its clinical application.

The study highlights that while sEMG can track small progress in recovery, its current design and user interface are seen as cumbersome, indicating a need for improvements to make it more user-friendly and effective in neurorehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's All Sort of Cool and Interesting…but What Do I Do With It?" A Qualitative Study of Stroke Survivors' Perceptions of Surface Electromyography. Feldner, HA., Papazian, C., Peters, K., et al.[2023]

The electromyography-driven robot system combined with neuromuscular electrical stimulation (NMES) significantly improved finger movement accuracy and muscle activation in five stroke patients, demonstrating its potential for enhancing rehabilitation outcomes.

After a 20-session training program, upper limb function improved in chronic stroke patients, as indicated by better scores on clinical assessments and reduced muscle co-contraction, suggesting that this combined approach effectively aids recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. Rong, W., Tong, KY., Hu, XL., et al.[2022]

In a study involving 5 patients with hemiplegic upper limb motor disorders post-stroke, visually displayed EMG feedback significantly improved motor control, particularly in elbow movements, with all patients regaining control of at least one targeted activity.

While shoulder flexion and finger extension showed clinical improvements in some patients, only specific cases could be statistically linked to EMG gains, indicating that the effectiveness of the feedback varied among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visually displayed EMG feedback: single case studies of hemiplegic upper extremity rehabilitation. Gianutsos, JG., Eberstein, A., Krasilovsky, G., et al.[2019]

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]

Surface electromyography (sEMG) systems are not commonly used in neurologic rehabilitation, despite clinicians recognizing their potential benefits for targeted populations, such as improving assessment and intervention strategies.

Key barriers to the adoption of sEMG include limited time and resources, highlighting the need for more streamlined and user-friendly systems to enhance clinical effectiveness and encourage implementation in rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Look, Your Muscles Are Firing!": A Qualitative Study of Clinician Perspectives on the Use of Surface Electromyography in Neurorehabilitation. Feldner, HA., Howell, D., Kelly, VE., et al.[2023]

The use of MIRA technology for upper limb rehabilitation in 10 adult patients post-neurological damage was feasible and did not negatively impact service operations or lead to any adverse events.

Patients generally enjoyed using MIRA and found it helpful in supplementing their prescribed exercises, especially those with prior experience in technology, although some reported discomfort during exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using MIRA with adult patients presenting with upper limb motor dysfunction post neurological damage. McGlinchey, M., Curtis, A., Ritchie, R., et al.[2017]

In a study of 20 stroke patients with partial paralysis, those who received bilateral movement and stimulation showed significantly higher muscle activation levels in their wrist and finger extensors compared to those who received unilateral treatment.

The results suggest that bilateral neuromuscular stimulation can enhance voluntary control and improve motor capabilities in impaired muscles, as indicated by increased EMG activation levels over the course of the treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress toward motor recovery with active neuromuscular stimulation: muscle activation pattern evidence after a stroke. Cauraugh, JH., Kim, S.[2019]

Myoelectric signals (EMG) provide valuable information about muscle contractions and can be used to control neurorehabilitation devices, making them effective for restoring or enhancing lost muscle functions.

EMG-based systems are utilized in various applications, including prostheses, rehabilitation robots, and functional electrical stimulation, highlighting their versatility and effectiveness in both research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric control in neurorehabilitation. Jiang, N., Falla, D., d'Avella, A., et al.[2019]

A new myoelectric control system was developed to help stroke survivors by accurately detecting their intention to move their affected limbs, using high-density surface EMG recordings from 12 participants.

The system achieved a high classification accuracy of 96.1%, demonstrating that significant motor control information can be extracted from the muscles of stroke survivors, which could enhance rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-density myoelectric pattern recognition toward improved stroke rehabilitation. Zhang, X., Zhou, P.[2016]

High density surface electromyogram (sEMG) recordings can effectively extract motor control information from the muscles of 12 chronic stroke patients, enabling the classification of 20 different movements.

Improvements in classification performance were achieved through spatial filtering and optimizing parameters like analysis window length and sampling rate, which can enhance myoelectric control for stroke rehabilitation while reducing computational costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Several practical issues toward implementing myoelectric pattern recognition for stroke rehabilitation. Li, Y., Chen, X., Zhang, X., et al.[2016]

The newly developed EMG-controlled knee exoskeleton allows stroke patients to engage in rehabilitation at home, significantly simplifying the setup process to just 72 seconds and enabling autonomous control through EMG signals.

Initial tests with six healthy subjects demonstrated that the exoskeleton not only improved user engagement through a game-based training approach but also enhanced control performance, indicating its potential effectiveness for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an EMG-Controlled Knee Exoskeleton to Assist Home Rehabilitation in a Game Context. Lyu, M., Chen, WH., Ding, X., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Muscle Activity After Stroke: Perspectives on Deploying Surface Electromyography in Acute Care. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

"It's All Sort of Cool and Interesting…but What Do I Do With It?" A Qualitative Study of Stroke Survivors' Perceptions of Surface Electromyography. [2023]

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

Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. [2022]

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

Visually displayed EMG feedback: single case studies of hemiplegic upper extremity rehabilitation. [2019]

5. 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]

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

"Look, Your Muscles Are Firing!": A Qualitative Study of Clinician Perspectives on the Use of Surface Electromyography in Neurorehabilitation. [2023]

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

Feasibility of using MIRA with adult patients presenting with upper limb motor dysfunction post neurological damage. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Progress toward motor recovery with active neuromuscular stimulation: muscle activation pattern evidence after a stroke. [2019]

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

Myoelectric control in neurorehabilitation. [2019]

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

High-density myoelectric pattern recognition toward improved stroke rehabilitation. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Several practical issues toward implementing myoelectric pattern recognition for stroke rehabilitation. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Development of an EMG-Controlled Knee Exoskeleton to Assist Home Rehabilitation in a Game Context. [2023]