EMG-Controlled Game Therapy for Stroke

(GAM Trial)

Overseen By Sarah A Jackson, BA MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Spasticity medications

Disqualifiers: Concurrent rehabilitation, Sensory loss, others

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

Compensation: Varies

Number of Visits: 23

Duration: 10 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if practicing specific muscle movements and tasks can improve arm function in individuals who have had a stroke. Participants will either play EMG-controlled games, which use muscle activity to control the game, or focus solely on task practice. This trial is ideal for those who had a stroke more than six months ago and still face challenges with one arm. Participants should be able to see a computer screen and understand the study tasks. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods and contribute to advancing stroke recovery research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have changed your spasticity medication or had a botulinum toxin injection in the upper limb within 3 months before or during the study.

What prior data suggests that this EMG-Controlled Game Therapy is safe for stroke survivors?

Research has shown that stroke survivors can safely use games controlled by muscle signals (EMG) to train their muscles. These games improve muscle control without causing serious side effects.

Similarly, studies have found that practicing specific tasks repeatedly, known as task-specific training, is safe and well-tolerated. This training improves movement and strength in people recovering from a stroke, with no major safety issues reported.

Both EMG-controlled games and task-specific training have been successfully used in previous studies with stroke survivors. Designed to enhance arm and hand function, they are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EMG-controlled game therapy for stroke rehabilitation because it introduces a new way to engage patients in their recovery. Unlike standard therapies that focus solely on repetitive task practice, this approach uses electromyography (EMG) to control games, making muscle activation patterns an interactive part of therapy. This method not only enhances motivation by making exercises more engaging but also provides real-time feedback, which can help patients fine-tune their movements more effectively. By combining fun with function, this innovative technique seeks to improve outcomes and make rehabilitation a more rewarding experience.

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

Research has shown that games controlled by muscle signals can help stroke survivors practice using their muscles. In this trial, participants in one arm will train with EMG-controlled games combined with functional task practice. Earlier studies demonstrated that stroke patients using these games gained better muscle control. This therapy encourages trying different muscle movements, which can enhance arm and hand function. Although more information is needed, early results suggest it could be promising for improving movement after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Na Jin Seo, PhD MS BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for stroke survivors over 18 years old with moderate upper limb impairment, who can see a computer screen and have the cognitive ability to follow study procedures. It's not suitable for those with severe language or cognitive barriers, total sensory loss in the limbs, ongoing arm rehab, extreme muscle stiffness preventing movement, recent spasticity treatment changes, or other conditions affecting arm use.

Inclusion Criteria

I had a stroke over 6 months ago.

I have moderate difficulty using my arms.

I am mentally capable of following the study's procedures.

Exclusion Criteria

I am currently undergoing rehabilitation for my upper limb.

I haven't changed my spasticity medication or had a botulinum toxin injection in my arm in the last 3 months.

My severe muscle stiffness prevents me from moving my muscles voluntarily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive upper limb task practice and muscle activity training

10 weeks

23 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• practice muscle activation patterns
• task practice

Trial Overview

The study tests whether practicing muscle activation patterns and task practice can improve arm function after a stroke. Participants will visit the lab three times weekly for six weeks to engage in these activities and will also attend three additional visits for assessments of their arm function over about 2.5 months.

How Is the Trial Designed?

Group I: EMG + task training Experimental Treatment 2 Interventions

Train with EMG-controlled games and functional task practice

Group II: task training Active Control 1 Intervention

Train with functional task practice

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

The study involved 20 chronic stroke survivors with moderate hand impairment who trained using EMG-controlled games over 9 sessions, achieving a high adherence rate of 97.8% and no dropouts.

Both unilateral and bilateral training significantly improved muscle activation control, as evidenced by faster cursor movement to targets and better scores on the Wolf Motor Function Test, indicating the feasibility of this training method for enhancing hand function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. Seo, NJ., Barry, A., Ghassemi, M., et al.[2023]

A novel electromyographic control platform for a serious game showed potential in improving hand control in neurologically intact subjects, suggesting it could be beneficial for stroke rehabilitation.

Both unilateral and bilateral training groups demonstrated improved performance in cursor control with their non-dominant hand, indicating that this approach may help in reorganization of muscle activation patterns for better functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an EMG-Controlled Serious Game for Rehabilitation. Ghassemi, M., Triandafilou, K., Barry, A., et al.[2020]

A custom surface electromyography device integrated with a video game was developed to enhance rehabilitation for patients with severe upper extremity weakness, showing high sensitivity in detecting voluntary muscle activation across 10 distinct muscles.

In a trial with 19 patients, including those who had undergone nerve and tendon transfers, the therapeutic gaming platform was found to be enjoyable and motivating, suggesting it could improve adherence to therapy and potentially enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface Electromyography-Driven Therapeutic Gaming for Rehabilitation of Upper Extremity Weakness: A Pilot Study. Liu, Y., Silva, RML., Friedrich, JB., et al.[2023]

This systematic review aims to evaluate the effects of game-based rehabilitation on upper limb function in adults recovering from stroke within the first six months, a critical period for motor recovery.

The review will include randomized clinical trials and follow rigorous methodologies to assess the immediate, short-term, and long-term benefits of this intervention, potentially providing strong evidence for its effectiveness in enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based rehabilitation on upper limb function in adults within the first six months following stroke: protocol for a systematic review and meta-analysis. Ali A, S., Arumugam, A., Gururaj, S., et al.[2022]

In a study involving 51 patients recovering from a stroke, video game-based rehabilitation showed a significant improvement in gross grasping function (measured by the Box and Block Test) compared to conventional rehabilitation, especially when started within the first month after the stroke.

Overall, while there were no significant long-term differences in upper limb recovery between video games and conventional therapy, video gaming proved to be more effective for patients who began treatment within 30 days post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. Laffont, I., Froger, J., Jourdan, C., et al.[2021]

The study involves 120 adults with acute or sub-acute unilateral stroke, who will participate in a 2-week intensive rehabilitation program using the ArmAble™ device, followed by 4 weeks of home-based training, aiming to improve upper limb function through gamified therapy.

The effectiveness of the ArmAble™ device will be assessed using standardized tests like the Fugl-Meyer assessment and the action research arm test, with results expected to demonstrate significant improvements in motor function due to the engaging and repetitive nature of the game-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial. Sulfikar Ali, A., Arumugam, A., Kumaran D, S.[2021]

Training with the myogame 'Breakout-EMG' significantly improved EMG control and in-game accuracy among 28 able-bodied participants compared to a control group playing a regular game.

However, the improvements in myoelectric control did not translate to better performance in a prosthesis-simulator task, indicating that while myogames enhance specific skills, transferring those skills to real-world prosthetic use remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning an EMG Controlled Game: Task-Specific Adaptations and Transfer. van Dijk, L., van der Sluis, CK., van Dijk, HW., et al.[2019]

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]

A randomized controlled trial with 14 patients who had upper extremity amputations showed that game-based rehabilitation improved EMG control and fine muscle activation compared to standard training methods.

Patients reported higher motivation and enjoyment with game-based interventions, particularly with rhythm-based games, suggesting that these approaches can enhance engagement and effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PlayBionic: Game-Based Interventions to Encourage Patient Engagement and Performance in Prosthetic Motor Rehabilitation. Prahm, C., Kayali, F., Sturma, A., et al.[2022]

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EMG-Controlled Game Therapy for Stroke (GAM Trial)

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The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors.