MyoPro-Assisted Therapy for Stroke

Overseen By Jessica P McCabe, MPT DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Previous stroke, Severe shoulder issues, Seizures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 18 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the MyoPro, a special wearable device, improves arm movement in individuals who had a stroke over six months ago. Participants will either use the MyoPro with motor learning therapy or receive the therapy alone to assess which approach is more effective. The trial also examines potential brain changes in response to treatment and evaluates the cost-effectiveness of the MyoPro. Individuals who have experienced a stroke, suffer from severe arm weakness, and can generate detectable muscle signals might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications that lower the threshold for seizures, you may not be eligible to participate.

What prior data suggests that the MyoPro device is safe for use in stroke therapy?

Research has shown that the FDA has approved the MyoPro device as a Class II medical device, indicating it meets specific safety standards. However, limited research exists on its long-term safety or effectiveness. The device assists people with weak or paralyzed arms by using muscle signals to aid movement. Although it appears promising for some users, the absence of detailed studies means potential side effects remain unknown. Always consult a healthcare provider when considering new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MyoPro-assisted therapy for stroke rehabilitation because it uniquely combines advanced robotics with motor learning principles. Unlike traditional physical therapy, which often relies on repetitive exercises, MyoPro pairs a wearable robotic device with therapy to enhance the brain's ability to rewire and improve motor function. This innovative approach not only supports the affected limb but also actively engages it, potentially leading to more significant recovery outcomes. By integrating technology with therapy, this method offers hope for faster and more effective stroke recovery, setting it apart from existing treatments.

What evidence suggests that the MyoPro device is effective for stroke rehabilitation?

Research shows that the MyoPro device can help stroke survivors improve arm movement. In this trial, one group of participants will receive MyoPro paired with motor learning-based therapy, while another group will receive only motor learning-based therapy. Earlier studies found that patients using MyoPro had better control over their movements and could perform more everyday tasks with their affected arm. The device detects weak muscle signals and assists with movement, making arm use easier. Studies have also found that wearing the MyoPro can reduce arm movement difficulties, aiding recovery after a stroke. Overall, therapy with MyoPro shows promising results for those with severe arm movement issues post-stroke. ^{1 3 6 7 8}

Who Is on the Research Team?

Svetlana Pundik, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

Adults aged 18-89 with severe arm weakness from a stroke that happened at least 6 months ago can join. They must be able to move their shoulder a bit, wear the MyoPro device, and produce muscle signals it can read. People with metal in their skull, pacemakers, or conditions like seizures or claustrophobia that make MRI scans unsafe cannot participate.

Inclusion Criteria

I can undergo TMS (Transcranial Magnetic Stimulation) procedures.

I can lift my arm forward at least 30 degrees and to the side at least 20 degrees.

I can move my elbow, forearm, wrist, and hand well enough to use the device.

Exclusion Criteria

Pregnancy or pregnancy planning during the study period

I have metal in my skull or a skull deformity.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 9 weeks of in-clinic training with MyoPro and motor learning-based therapy, followed by 9 weeks of home practice

18 weeks

18 in-clinic sessions over 9 weeks, followed by home practice

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessments at weeks 1, 4, 9, 18, and 24

What Are the Treatments Tested in This Trial?

Interventions

• Motor Learning-Based Therapy
• MyoPro

Trial Overview

The trial is testing if using the MyoPro exoskeleton along with motor learning therapy helps people recover arm function after a chronic stroke better than therapy alone. It also looks into how the brain changes during recovery and which patients benefit most.

How Is the Trial Designed?

Group I: M+ML Experimental Treatment 3 Interventions

MyoPro paired with motor learning based therapy

Group II: ML-alone Active Control 2 Interventions

motor learning based therapy alone

Motor Learning-Based Therapy is already approved in United States, European Union for the following indications:

Approved in United States as MyoPro for:

• Severe chronic arm motor deficits due to stroke

Approved in European Union as MyoPro for:

• Neuromuscular rehabilitation for conditions such as stroke, spinal cord injury, and brachial plexus injury

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

EMG feedback training significantly improved muscle control and range of motion in five stroke patients with hemiplegia compared to unassisted practice.

Adding monetary incentives to the EMG feedback training further enhanced these improvements, likely by increasing patient motivation during the training sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentives to enhance the effects of electromyographic feedback training in stroke patients. Santee, JL., Keister, ME., Kleinman, KM.[2019]

The approach to physical rehabilitation for stroke patients is evolving from simply treating physical impairments to focusing on educating patients to re-learn motor tasks, which enhances their ability to adapt movement strategies for daily activities.

Optimizing motor learning in stroke patients requires integrating clinical research with reflective practice, emphasizing the importance of understanding how patients process information and practice movements effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Motor Learning Principles to the Stroke Population. Majsak, MJ.[2019]

Experienced physiotherapists in neurological rehabilitation utilize a wide range of motor learning options, with 34 specific strategies identified under the 'act' operator, which includes instruction, feedback, and organization.

The decision-making process for selecting motor learning options is complex and involves interrelated factors such as knowledge, observation, assessment, and argumentation, suggesting that therapists adapt their approaches based on individual patient needs beyond standard guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapists use a great variety of motor learning options in neurological rehabilitation, from which they choose through an iterative process: a retrospective think-aloud study. Kleynen, M., Moser, A., Haarsma, FA., et al.[2018]

Robot-assisted training for both upper and lower limbs is currently the most promising method for restoring motor function after a stroke, as shown by various clinical trials of devices like MIT-Manus and Lokomat.

Patients who undergo robot-assisted training combined with traditional physiotherapy show greater improvements in motor function compared to those who receive only physiotherapy or only robotic training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer of scientific concepts to clinical practice: recent robot-assisted training studies. Waldner, A., Tomelleri, C., Hesse, S.[2019]

The field of neurorehabilitation has shifted towards evidence-based practices, emphasizing the importance of scientific research in developing effective therapies for motor recovery after conditions like stroke and traumatic brain injury.

Innovative treatment strategies now focus on group-oriented approaches and hands-off coaching, utilizing principles from motor learning and reorganization, which can be tailored to meet individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurorehabilitation approaches to facilitate motor recovery. Hömberg, V.[2013]

Robot-assisted movement training can enhance arm movement ability after stroke, with initial findings suggesting that mechanically assisted reaching may improve recovery similarly to unassisted practice, although this was based on a small pilot study of 19 participants.

The study indicates that requiring patients to generate specific force patterns before movement may be more effective than simply completing movements for them, highlighting the potential for 'guided-force training' to optimize rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted movement training for the stroke-impaired arm: Does it matter what the robot does? Kahn, LE., Lum, PS., Rymer, WZ., et al.[2022]

In a study involving 12 individuals with neurological gait disorders, both computerized visual feedback and verbal instructions from a therapist led to similar improvements in motor output during robotic-assisted gait training.

Participants reported feeling more motivated and focused when using visual feedback, suggesting it enhances engagement in the rehabilitation process, making it a valuable tool alongside traditional verbal guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized visual feedback: an adjunct to robotic-assisted gait training. Banz, R., Bolliger, M., Colombo, G., et al.[2022]

A technology-dependent therapy for upper limb rehabilitation in older adults post-stroke was feasible, with 11 out of 13 participants completing the 18-day program in their homes, indicating potential for increased therapy dose.

While effectiveness could not be conclusively determined, there were trends suggesting improvements in upper limb function and emotional well-being, highlighting the need for further research with a larger sample size and control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Dependent Rehabilitation Involving Action Observation and Movement Imagery for Adults with Stroke: Can It Work? Feasibility of Self-Led Therapy for Upper Limb Rehabilitation after Stroke. McCormick, SA., Ireland, C., Yohannes, AM., et al.[2022]

A hand exoskeleton using myoelectric pattern recognition effectively assisted a 52-year-old stroke patient in regaining hand function over 10 weeks of training, showing significant improvements in grip and pinch force as well as overall hand function scores.

The patient, who initially could not move her fingers, demonstrated measurable progress in performing six different hand motions, indicating that this technology can facilitate rehabilitation and enhance motor recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Myoelectric Control for Robotic Hand-Assisted Training: Outcome from a Stroke Patient. Lu, Z., Tong, KY., Shin, H., et al.[2020]

Robot-assisted motion therapy is gaining traction in neurorehabilitation and orthopedic recovery, showing higher effectiveness when patients actively participate compared to traditional continuous passive motion machines.

A new assistive control concept using compliant actuators has been developed for knee and shoulder rehabilitation, with the Knee-MTD prototype currently being tested in a clinical setting to validate its effectiveness in real-life conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive control of motion therapy devices based on pneumatic soft-actuators with rotary elastic chambers. Wilkening, A., Baiden, D., Ivlev, O.[2016]

A long-term trial compared the effects of electromyographic biofeedback (EMGBF) combined with physiotherapy (PT) to PT alone in stroke patients with hemiplegic upper limbs, showing that both groups benefited from treatment.

The study found that EMGBF provided additional benefits, enhancing recovery not only in patients receiving it initially but also in those who switched from PT alone to the EMGBF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyographic biofeedback and physical therapy of the hemiplegic upper limb. Inglis, J., Donald, MW., Monga, TN., et al.[2009]

Biofeedback during lower limb activities significantly improves performance compared to usual therapy, with a moderate effect size (SMD 0.50) based on a systematic review of 18 trials involving 429 stroke participants.

The quality of the trials was moderately high, suggesting that biofeedback could be a valuable and cost-effective addition to rehabilitation practices for stroke patients, although further research is needed to assess long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback improves performance in lower limb activities more than usual therapy in people following stroke: a systematic review. Stanton, R., Ada, L., Dean, CM., et al.[2022]

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Giving Them a Hand: Wearing a Myoelectric Elbow-Wrist-Hand Orthosis Reduces Upper Extremity Impairment in Chronic Stroke. Arch Phys Med Rehabil. 2017 Jan 24. 4.

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What is A MyoPro Orthosis

MyoPro is a powered arm and hand orthosis (brace) designed to help restore function to the wearer's paralyzed or weakened upper extremities.