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

Trial Summary

What is the purpose of this trial?

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. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

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 data supports the effectiveness of the treatment EMG-Controlled Game Therapy for Stroke?

Research suggests that game-based rehabilitation, which includes EMG-controlled games, can improve upper limb function in stroke survivors by making therapy more engaging and motivating. These games help retrain muscle activation patterns, which is crucial for recovery after a stroke. ^{1 2 3 4 5}

Is EMG-Controlled Game Therapy safe for humans?

Research on EMG-Controlled Game Therapy shows it is generally safe for humans, as studies report it being enjoyable, motivating, and easy to use without mentioning any adverse effects. It has been tested in people with stroke, nerve injuries, and spinal cord injuries, and participants and therapists have expressed positive feedback about its use. ^{1 5 6 7 8}

How is EMG-Controlled Game Therapy different from other stroke treatments?

EMG-Controlled Game Therapy is unique because it uses electromyographic (EMG) signals to control video games, helping stroke survivors retrain their muscle activation patterns. Unlike conventional therapies that focus on strengthening existing muscle activation, this approach targets reorganizing abnormal muscle patterns, making it a novel method for improving hand function after a stroke. ^{1 3 5 8 9}

Research Team

Na Jin Seo, PhD MS BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

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 am 18 years old or older.

I had a stroke over 6 months ago.

I have moderate difficulty using my arms.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

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

PlayBionic: Game-Based Interventions to Encourage Patient Engagement and Performance in Prosthetic Motor Rehabilitation. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. [2021]

4. United States 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. [2022]

5. United States 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. [2021]

6. 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]

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

Surface Electromyography-Driven Therapeutic Gaming for Rehabilitation of Upper Extremity Weakness: A Pilot Study. [2023]

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

Development of an EMG-Controlled Serious Game for Rehabilitation. [2020]

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

Learning an EMG Controlled Game: Task-Specific Adaptations and Transfer. [2019]