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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called MARK, designed to help stroke survivors with severe arm issues regain function. The researchers aim to determine if using this device early in rehabilitation improves arm movement more effectively than standard care alone. They seek participants who have experienced an ischemic stroke within the last six months and have some ability to move their arm muscles. This device could help stroke survivors perform daily activities more independently. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance rehabilitation options for future stroke survivors.

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 prior data suggests that this EMG-controlled device is safe for stroke rehabilitation?

Research has shown that devices controlled by EMG (electromyography) can safely aid stroke recovery. Studies have found that these devices improve arm movement more effectively than standard treatments. They function by using muscle signals to assist brain recovery after a stroke.

Reports do not highlight any major safety issues with these devices. For instance, studies found that EMG-based therapy improved arm control and reduced muscle stiffness without causing serious side effects. Additionally, similar wearable technology is often used in stroke recovery, indicating general acceptance.

Overall, early results are promising. They suggest that using an EMG-controlled device for stroke recovery is safe and may enhance arm movement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stroke rehabilitation, like physical therapy and occupational therapy, focus on repetitive movements to help patients regain strength and mobility. However, the EMG-Controlled Device is unique because it integrates electromyography (EMG) technology to actively involve stroke patients in their recovery process. This device interprets muscle signals to guide movements, allowing for more precise and personalized rehabilitation exercises. Researchers are excited about this approach because it could lead to improved motor recovery by tailoring therapy to an individual's specific muscle activity, potentially accelerating and enhancing the rehabilitation process compared to traditional methods.

What evidence suggests that this EMG-controlled device is effective for stroke rehabilitation?

Research has shown that a special device controlled by muscle signals can improve arm function in stroke patients. This trial will explore the feasibility of adding an EMG-controlled device to acute rehabilitation for stroke subjects with severe arm deficits. Studies have found that these devices enhance arm movement and reduce muscle stiffness. One study found that these tools outperform regular therapies in improving arm movement and daily activities. A review of 25 studies reported positive results for arm recovery with these devices. Overall, early findings suggest these devices play a crucial role in stroke recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Ahlam Salameh, PhD MSc

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

A systematic review on functional electrical stimulation ... The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04599036?draw=2&rank=1

EMG Controlled Device in Acute Rehabilitation After ... The rationale of this study is to explore if an EMG controlled device can be added to the acute rehabilitation for stroke subjects with severe arm deficit. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10226272/

Effects of EMG-based robot for upper extremity rehabilitation ... The effect of EMG-based robot is superior to conventional therapies in terms of improving upper extremity motor control, spasticity and activity limitation.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590123023008526

Maximizing stroke recovery with advanced technologies In this paper, the use of EMG-based robot aided therapy has been discussed and highlights the contribution of interventions for stroke rehabilitation.

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00961-w

Comparative effects of EMG-driven robot-assisted therapy ... EMG-driven hand robot has shown to increase voluntary motor control, decrease muscle spasticity and improve upper limbs motor function [16,17,18] ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04599036

EMG Controlled Device in Acute Rehabilitation After ... Several studies revealed that rehabilitation during this acute period of injury would enhance the functional outcome of the paretic arm presumably by modulating ...

7. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1172958/full

Effects of EMG-based robot for upper extremity ... The effect of EMG-based robot is superior to conventional therapies in terms of improving upper extremity motor control, spasticity and activity limitation.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6862815/

Wearable technology in stroke rehabilitation The present review aims to provide an overview of wearable sensors used in stroke rehabilitation research, with a particular focus on the upper extremity.