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

Trial Summary

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 data supports the effectiveness of the treatment MyoPro-Assisted Therapy for Stroke?

Research suggests that robot-assisted movement training, which involves both patient effort and robotic assistance, can improve arm movement after a stroke. Although the specific role of robotic forces is still unclear, studies indicate that combining movement practice with robotic assistance may offer additional benefits. ^{1 2 3 4 5}

Is MyoPro-Assisted Therapy for Stroke safe for humans?

The research articles provided do not contain specific safety data for MyoPro-Assisted Therapy or its related names. Therefore, no relevant safety information is available from these sources. ^{1 5 6 7 8}

How is MyoPro-Assisted Therapy for Stroke different from other treatments for stroke?

MyoPro-Assisted Therapy for Stroke is unique because it uses a myoelectric orthosis, which detects the user's muscle signals to assist in movement, allowing patients to actively participate in their rehabilitation. This approach contrasts with traditional therapies that may rely more on passive movement, as it encourages patients to use their own muscle strength, potentially leading to better recovery outcomes. ^{1 9 10 11 12}

What is the purpose of this trial?

This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.

Research Team

Svetlana Pundik, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Robot-assisted movement training for the stroke-impaired arm: Does it matter what the robot does? [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England 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. [2018]

4. United States 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neurorehabilitation approaches to facilitate motor recovery. [2013]

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

Electromyographic biofeedback and physical therapy of the hemiplegic upper limb. [2009]

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

Incentives to enhance the effects of electromyographic feedback training in stroke patients. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Biofeedback improves performance in lower limb activities more than usual therapy in people following stroke: a systematic review. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Transfer of scientific concepts to clinical practice: recent robot-assisted training studies. [2019]

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

Computerized visual feedback: an adjunct to robotic-assisted gait training. [2022]

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

Assistive control of motion therapy devices based on pneumatic soft-actuators with rotary elastic chambers. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Advanced Myoelectric Control for Robotic Hand-Assisted Training: Outcome from a Stroke Patient. [2020]