EMG Biofeedback Training for Multiple Sclerosis

(MSBAL Trial)

Overseen By Aimee J Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Botox

Disqualifiers: Cognitive deficit, Visual disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with multiple sclerosis (MS) improve their balance. It compares novel EMG biofeedback training, which uses sensors to guide movements, with traditional balance exercises. The researchers aim to determine if this new method provides better, longer-lasting balance improvements. Individuals with MS who can walk and experience balance difficulties might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new balance improvement methods for MS.

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must agree not to change the dosage or start new medications during the study.

What prior data suggests that this EMG Biofeedback training method is safe for individuals with multiple sclerosis?

Research has shown that EMG Biofeedback Training, which uses sensors to provide feedback during exercise, has been tested for safety in previous studies. This training is generally well-tolerated, with few reports of side effects. The sensors are non-invasive and adhere to the skin like a band-aid.

Due to the lack of detailed side effect data from past studies, this trial is labeled as "Not Applicable" for study phase. This often indicates an early research study or involves a device or technique already considered safe, suggesting no known serious safety concerns. Participants often find this feedback training engaging and easy to follow.

The Traditional Balance Exercise Training, used for comparison, involves exercises commonly recommended by physiotherapists. These exercises are widely used and have a strong safety record, with most people handling them without issues.

In summary, both training methods in this trial appear safe based on past studies and their nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Dual-task EMG Biofeedback Training for multiple sclerosis because it offers a novel way to enhance motor and cognitive functions simultaneously. Unlike traditional physiotherapy, which often focuses on separate physical exercises, this approach integrates biofeedback with a video game, Tetris, to challenge both the mind and body. By linking specific muscle movements to game commands and shuffling these commands each session, it encourages patients to adapt and think critically, potentially improving both muscle coordination and cognitive flexibility. This dual-task method could provide a more engaging and holistic rehabilitation experience for those with multiple sclerosis.

What evidence suggests that this EMG Biofeedback Training is effective for improving balance in individuals with multiple sclerosis?

Research has shown that dual-task EMG Biofeedback training, which participants in this trial may receive, can help people with multiple sclerosis improve their balance. This training combines muscle feedback with mental tasks, and previous studies have demonstrated that it enhances walking ability and speed. Early findings suggest that adding mental tasks can improve motor skills by simultaneously challenging both the brain and body. This method uses sensors to provide real-time feedback, helping users adjust their movements for better balance. While traditional balance exercises, part of another treatment arm in this trial, work well, EMG Biofeedback training might offer extra benefits by involving both the mind and body. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis who are looking to improve their balance. Participants will be involved in a 6-week training program, with follow-up after three months. The study aims to include people at different levels of disability but has not specified any exclusion criteria.

Inclusion Criteria

My disease has not worsened in the last 3 months.

I can walk but have issues with walking or balance.

I agree not to start or change any medications during the study.

Exclusion Criteria

Presence of visual disorders that prevent meaningful interaction with the intervention interface

I have received Botox treatment within the last 3 months.

Unable to follow instructions due to cognitive deficit or language barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EMG Biofeedback training or traditional balance exercise training for 6 weeks, with three 30-minute sessions per week

6 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for balance and related outcomes 3 months after the end of training

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Dual-task EMG Biofeedback Training

Trial Overview The study compares two types of balance training: EMG Biofeedback Training (EMG-BF), which uses sensors and feedback during exercise, and Traditional Balance Exercise Training (BAL-EX), which follows standard physiotherapy movements. Each participant undergoes three 30-minute sessions weekly for six weeks.

How Is the Trial Designed?

Group I: Integrated Dual-task EMG Biofeedback Training (EMG-BF) Experimental Treatment 1 Intervention

Participants will engage in EMG-BF for 30 minutes 3 times per week for 6 weeks for a total of 18 sessions. Our novel EMG Biofeedback training system can be adapted to a training objective by planning 3 to 5 movements and placing sensors over muscles that must be active when the user adheres to the correct movement form. For our training we use right or left torso shift with knee bend, and right or left hand opening, and place sensors over left and right vastus lateralis and left and right extensor digitorum superficialis muscles. Each movement corresponds to a specific videogame command. To introduce cognitive challenge, we randomly shuffle the game command assigned to each movement at the beginning of every session. This will require the user to choose the appropriate movement to trigger the intended game input while suppressing incorrect movements. We use the puzzle game, Tetris, which requires spatial reasoning and planning under increasingly tight time constraints.

Group II: Traditional Balance Exercise Training (BAL-EX) Active Control 1 Intervention

Participants will perform 7 balance exercises traditionally prescribed by physiotherapists. The first is a heel/toe square exercise where the trainee lifts their right toe and left heel, then their left toe and right heel, then both heels, then both toes. The 2nd exercise involves maintaining tandem stance while static, then moving the arms, then looking up and down, then looking left and right. The 3rd exercise is lateral stepping where the individual steps with one foot out to the side and then bring the foot back to the starting stance. The 4th exercise is a golfer's lift where the person slowly leans forward while extending one leg straight behind and touches the seat of a chair placed opposite. The 5th exercise is extended-duration single leg stands and exercises 6 and 7 are back and side leg raises, respectively. The exercise sequence will repeat until 30 minutes has expired. Sessions are repeated 3 times per week for 6 weeks, for 18 sessions.

Integrated Dual-task EMG Biofeedback Training is already approved in Canada for the following indications:

Approved in Canada as EMG Biofeedback Training for:

• Improvement of balance in individuals with multiple sclerosis

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Multiple Sclerosis Society of Canada

Collaborator

Trials

17

Recruited

990+

Published Research Related to This Trial

The study demonstrated the feasibility of dual task training in individuals with Multiple Sclerosis, with a 70% retention rate and 100% adherence among participants over a 12-week intervention.

Participants in the dual task training group showed trends toward improved gait speed and better visuospatial memory compared to the control group, suggesting potential benefits of incorporating cognitive tasks into balance and walking training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual task training in persons with Multiple Sclerosis: a feasability randomized controlled trial. Sosnoff, JJ., Wajda, DA., Sandroff, BM., et al.[2019]

In a study involving 11 patients with chronic spastic hemiparesis, a modified biofeedback method called biosignal processing (BSP) led to improved muscle strength and movement competence after 12 to 30 treatment sessions.

Ten out of eleven patients showed increased strength, and four patients significantly improved their ability to perform specific tasks with both upper and lower extremities, suggesting that integrating useful tasks into therapy can enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating chronic hemiparesis with modified biofeedback. Wissel, J., Ebersbach, G., Gutjahr, L., et al.[2009]

An 8-week virtual EMG biofeedback intervention significantly reduced pain intensity in patients with chronic low back pain (CLBP) compared to usual care, with a mean difference of 0.9 on the pain scale (p≤0.01).

Participants in the EMG biofeedback group also showed significant improvements in pain interference and disability, along with increased pain thresholds, indicating enhanced pain management and muscle relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study). Lazaridou, A., Paschali, M., Vilsmark, ES., et al.[2023]

In a study involving 14 patients with multiple sclerosis, half of the participants showed cognitive improvements in long-term memory and executive functions after completing ten sessions of EEG-based neurofeedback training.

The results suggest that successfully learning to self-regulate brain activity through neurofeedback may lead to cognitive enhancements, indicating its potential as a valuable tool for cognitive rehabilitation in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation of brain activity and its effect on cognitive function in patients with multiple sclerosis - First insights from an interventional study using neurofeedback. Kober, SE., Pinter, D., Enzinger, C., et al.[2020]

In a study of 18 patients with primary fibromyalgia, nine sessions of EMG biofeedback over four weeks led to a significant reduction in pain intensity and EMG activity in the trapezius muscle.

The improvement in muscular sensitivity was linked to decreased EMG activity, and changes in cognitive factors like helplessness and belief in control were associated with self-reported pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of muscular sensitivity, muscular activity, and cognitive variables for pain reduction associated with EMG biofeedback in fibromyalgia. Sarnoch, H., Adler, F., Scholz, OB.[2009]

Modern biofeedback techniques, particularly EMG biofeedback, are effective in rehabilitating patients with upper motor neuron lesions, such as those recovering from strokes, by helping them control muscle activity and reduce spasticity.

In conditions like cerebral palsy and musculoskeletal disturbances, the use of additional feedback devices is becoming more common, enhancing the effectiveness of treatment by providing more comprehensive data for muscle retraining.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback in rehabilitation: a review of principles and practices. Basmajian, JV.[2009]

The studies show a consistent negative correlation between baseline variability in electromyography (EMG) readings and the effectiveness of biofeedback-assisted EMG reduction, suggesting that higher baseline variability may lead to less effective biofeedback outcomes.

This finding could have important implications for optimizing biofeedback interventions, as understanding baseline EMG variability may help tailor treatments for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline variability as a predictor of EMG biofeedback performance. Malec, J., Phillips, AM., Sipprelle, CN.[2009]

Electromyographic (EMG) biofeedback is increasingly used to help patients regain control of muscles affected by neuromuscular disorders, showing promise in various conditions like poliomyelitis and nerve injuries.

However, most existing research lacks rigorous design and control, indicating a need for more structured studies to confirm the effectiveness of EMG biofeedback and to identify which patients and muscle groups benefit the most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyographic biofeedback: behavioral treatment of neuromuscular disorders. Keefe, FJ., Surwit, RS.[2019]

Neurofeedback (NFB) shows preliminary promise as a potential intervention for managing multiple sclerosis (MS) symptoms such as fatigue, depression, cognitive deficits, and pain, although the current data is limited and varied.

Further research is needed to optimize NFB protocols and explore its integration with other effective treatments, which could enhance the quality of life for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for the management of multiple sclerosis symptoms: current knowledge and future perspectives. Ayache, SS., Bardel, B., Lefaucheur, JP., et al.[2022]

A new computer program was created to analyze and provide biofeedback on muscle activity during wrist movements, helping patients with hemiplegia and cerebellar incoordination.

Over several weeks of training, all five patients successfully learned to adjust their muscle activation patterns, reducing unwanted coactivation of muscles and improving the control of individual muscle groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMG biofeedback in patients with motor disorders: an aid for co-ordinating activity in antagonistic muscle groups. Davis, AE., Lee, RG.[2019]

A 6-week surface electromyographic biofeedback (sEMG-BFB) intervention significantly improved upper extremity motor function in 38 participants recovering from stroke, with a mean increase of 4.79 points on the Fugl-Meyer Assessment immediately after the intervention.

Participants in the sEMG-BFB group also showed enhanced active range of motion and increased electromyographic activity in the upper trapezius muscle, indicating effective re-learning of motor control compared to the sham group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial. Lirio-Romero, C., Torres-Lacomba, M., Gómez-Blanco, A., et al.[2021]

Citations

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EMG Biofeedback Training to Improve Balance in ... The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/559188

EMG Biofeedback Training to Improve Balance in ... The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06461741/emg-biofeedback-training-to-improve-balance-in-individuals-with-multiple-sclerosis

EMG Biofeedback Training to Improve Balance in ... The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40737966/

A randomized controlled trial: Dual-Task Training in MS This study aimed to examine the effects of motor-motor and motor-cognitive dual-task training on walking ability, walking speed, balance, ...

5. withpower.com withpower.com/trial/phase-multiple-sclerosis-6-2024-cede4?condition=&query=Biofeedback+training&overallStatus=Recruiting&hasNoPlacebo=false

EMG Biofeedback Training for Multiple Sclerosis (MSBAL Trial) The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with ...

6. ctv.veeva.com ctv.veeva.com/study/emg-biofeedback-training-to-improve-balance-in-individuals-with-multiple-sclerosis

EMG Biofeedback Training to Improve Balance in Individuals ... The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in ...