Muscle Coordination Training for Stroke

(NICE Trial)

Overseen By Jinsook Roh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must be taking: Anti-spasticity

Disqualifiers: Orthopedic disorder, Cognitive impairment, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 22

Duration: 6 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve arm movement for people who have had a stroke. It tests two types of training: one focuses on muscle coordination using EMG (a method that records muscle activity), and the other on building muscle strength. The goal is to determine if these methods can predict and improve motor skills. Suitable candidates include those who had a stroke affecting one side of the body, have been stable in their condition for over six months, and are not experiencing severe muscle tightness.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.

Will I have to stop taking my current medications?

The trial requires that your current medication be maintained without changes for at least 3 months. Stable use of anti-spasticity medication is accepted.

What prior data suggests that this rehabilitative training is safe for stroke patients?

Research has shown that rehabilitation exercises for stroke recovery are generally safe. Techniques such as specific muscle and balance training can enhance endurance and coordination without causing harm.

The training in this trial focuses on improving muscle coordination. Studies have found that similar methods are well-tolerated by stroke patients, with no major negative effects commonly reported.

Overall, rehabilitation exercises are a standard part of stroke recovery. While individual experiences may differ, current evidence suggests these exercises are generally safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these rehabilitative training techniques for stroke recovery because they introduce innovative ways to improve muscle coordination and strength. Unlike traditional therapies that focus on simple repetitive movements, the neuromuscular coordination-guided training uses real-time electromyographic (EMG) feedback to help patients control a cursor on a screen through muscle contractions. This approach could enhance fine motor control and coordination. The force strengthening-guided training, on the other hand, challenges patients to use isometric force to move a cursor, potentially improving muscle strength and control by targeting different force directions. Both methods provide a more dynamic and interactive form of rehabilitation, which could lead to better outcomes for stroke survivors.

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

Research has shown that special training focused on muscle coordination can improve strength and movement after a stroke. In this trial, participants will join different rehabilitative training arms. One arm involves neuromuscular coordination-guided training, targeting muscle coordination and proving particularly effective for those with severe movement difficulties. Another arm involves force strengthening-guided training, focusing on improving strength through isometric force exercises. Studies have found that personalized rehabilitation programs enhance balance, walking, and muscle function in stroke patients. Additionally, evidence suggests that exercises aimed at improving muscle coordination can lead to better control and use of affected limbs. These findings support the potential of these innovative training methods to aid recovery after a stroke. ^{2 3 6 7 8}

Who Is on the Research Team?

Jinsook Roh, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 40-75 who have had a stroke and are stable, without severe muscle stiffness or recent botulinum toxin treatments. Healthy individuals with no neurological issues can also join. People with upper limb disorders, cognitive impairments, other neurological diseases, or pregnant women cannot participate.

Inclusion Criteria

I am between 40 and 75 years old with no brain injuries.

I am a stroke survivor aged 40-75, stable for over 6 months, not on recent botulinum toxin treatment, and can maintain my current medication.

Exclusion Criteria

I do not have upper limb disorders, cognitive issues affecting understanding, other neurological diseases, or joint sense loss in my arms, and I am not pregnant.

I am healthy, not pregnant, can consent, and have no history of neurological diseases or epilepsy in my family.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment of intermuscular coordination patterns and motor impairment using ARAT and FMA

1 week

1 visit (in-person)

Treatment

Participants perform EMG-guided exercises to improve intermuscular coordination and motor function

6 weeks

18 visits (in-person, 3 per week)

Follow-up

Participants are monitored for retention of treatment effects and undergo assessments using ARAT and FMA

3 months

2 visits (in-person, 1 and 3 months post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Rehabilitative Training

Trial Overview

The study tests two types of rehabilitative training to improve arm control after a stroke: one focuses on neuromuscular coordination and the other on strength building. It aims to see if these methods can change how muscles work together post-stroke.

How Is the Trial Designed?

Group I: Neuromuscular coordination-guided rehabilitative training Experimental Treatment 1 Intervention

Post-stroke participants will perform a center-out task by generating isometric contractions of multiple muscles to move the cursor on a screen while electromyographic (EMG) responses are recorded. Activation of each muscle (or muscle group) will be mapped to 1 of 4 directions within the multi-dimensional cursor space. We will derive the cursor position in real time using EMGs recorded from multiple arm muscles.

Group II: Force strengthening-guided rehabilitative training Active Control 1 Intervention

Post-stroke participants will perform a center-out task by generating isometric force to move the cursor on a screen. Participants will generate isometric force, which will move their cursor on the monitor. They will be trained to match one of the four force targets on display. We will derive the cursor position in real time using three forces (Fx, Fy, and Fz) measured at the load cell.

Rehabilitative Training is already approved in United States, European Union, Canada, China for the following indications:

Approved in United States as Rehabilitative Training for:

• Stroke rehabilitation
• Muscle impairment
• Motor function recovery

Approved in European Union as Rehabilitative Training for:

• Post-stroke rehabilitation
• Neurological rehabilitation
• Physical therapy

Approved in Canada as Rehabilitative Training for:

• Stroke recovery
• Motor skill rehabilitation
• Physical rehabilitation

Approved in China as Rehabilitative Training for:

• Post-stroke rehabilitation
• Neurological rehabilitation
• Physical therapy

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

Korea Advanced Institute of Science and Technology

Collaborator

Trials

6

Recruited

1,500+

UT Health Houston

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

The study involved 50 stroke patients with hemiplegia, who were divided into a control group receiving conventional rehabilitation and a study group using a balance trainer alongside conventional therapy.

Results showed that the balance trainer significantly improved balance and postural control, as measured by the Berg Balance Scale and Timed-Up and Go Test, compared to conventional rehabilitation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of exercises administered to stroke patients with balance trainer on rehabilitation results: a randomized controlled study. Ordahan, B., Karahan, AY., Basaran, A., et al.[2020]

Occupational therapy (OT) interventions show small but significant improvements in primary activities of daily living (ADL), extended ADL, and social participation for stroke patients, based on a review of 32 studies including 18 randomized controlled trials.

While comprehensive OT interventions are effective, the evidence for specific interventions like splint provision is insufficient, highlighting the need for more research to strengthen evidence-based practices in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy for stroke patients: a systematic review. Steultjens, EM., Dekker, J., Bouter, LM., et al.[2022]

Active neuromuscular stimulation and coupled bilateral coordination training are effective rehabilitation interventions for reducing motor disabilities and chronic hemiparesis after a stroke, based on sound theoretical and neurophysiological principles.

The evidence supports that these interventions promote activity-dependent neural plasticity, which is crucial for motor recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coupled rehabilitation protocols and neural plasticity: upper extremity improvements in chronic hemiparesis. Cauraugh, JH.[2016]

Only 53% of occupational and physical therapists surveyed were aware of the VA stroke rehabilitation guidelines, indicating a need for better education on these guidelines to improve secondary stroke prevention efforts.

Despite nearly half of the therapists providing health promotion activities to patients, physical therapists were significantly more likely to do so than occupational therapists, highlighting a potential area for improvement in occupational therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of secondary stroke in VA: role of occupational therapists and physical therapists. Schmid, AA., Butterbaugh, L., Egolf, C., et al.[2019]

A neuromuscular electrical stimulation (NMES) and robot hybrid system significantly improved movement accuracy and reduced muscular discoordination in the upper limbs of 11 chronic stroke patients during a 20-session rehabilitation program.

The system effectively enhanced coordination at the elbow, wrist, and fingers, as evidenced by significant improvements in clinical scores such as the Modified Ashworth Score and Fugl-Meyer Assessment after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Neuromuscular Electrical Stimulation (NMES) and robot hybrid system for multi-joint coordinated upper limb rehabilitation after stroke. Rong, W., Li, W., Pang, M., et al.[2022]

In a study involving 16 chronic stroke survivors and 8 healthy individuals, it was found that stroke-affected upper limbs can still modularize muscle activation similarly to healthy individuals during isokinetic movements, indicating potential for rehabilitation.

The research suggests that using biomechanical constraints during rehabilitation exercises may enhance intermuscular coordination in stroke survivors, which could lead to improved motor control and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in intermuscular coordination underlying isokinetic exercise after a stroke and their implications on neurorehabilitation. Park, JH., Shin, JH., Lee, H., et al.[2021]

The clinical practice guideline identified a core set of outcome measures (OMs) for assessing balance, gait, transfers, and patient-stated goals in adults with neurologic conditions, emphasizing their importance for monitoring patient progress and enhancing care efficiency.

Strong evidence supports the use of specific OMs like the Berg Balance Scale and the 10 Meter Walk Test for evaluating balance and gait changes, respectively, indicating their reliability and effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation: A CLINICAL PRACTICE GUIDELINE. Moore, JL., Potter, K., Blankshain, K., et al.[2019]

The ReTrain intervention, a group-based functional training program for stroke rehabilitation, was found to be acceptable to participants, highlighting its potential effectiveness in improving both physical and psychological outcomes post-stroke.

Key areas for improvement were identified, including the need to address fatigue management, optimize trainer-to-participant ratios, and enhance support for continued activity after the program ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and experience of a functional training programme (ReTrain) in community-dwelling stroke survivors in South West England: a qualitative study. Norris, M., Poltawski, L., Calitri, R., et al.[2019]

Recent rehabilitation technology for stroke patients should focus on task-oriented training that is tailored to individual patient goals and provides feedback on performance, reflecting a shift from traditional analytical methods.

The review highlights the need for technological systems to support engaging and contextually relevant arm-hand training in natural environments, which is essential for effective motor skill relearning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-assisted training of arm-hand skills in stroke: concepts on reacquisition of motor control and therapist guidelines for rehabilitation technology design. Timmermans, AA., Seelen, HA., Willmann, RD., et al.[2022]

The Synergy-Based Motor Therapy (SBMT) protocol significantly improved motor function in 40 post-stroke subjects, as evidenced by a notable increase in Fugl-Meyer Assessment scores from 26.30 to 35.20, indicating enhanced upper limb motor control.

Participants also showed significant improvements in the Wolf Motor Function Test and Barthel Index, suggesting that SBMT effectively aids in both motor function and self-care activities for individuals with chronic hemiparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergy-Based Motor Therapy Inducing Favorable Changes in Motor Function Components among Poststroke Subjects: A Single-Group Study. Pandian, S., Arya, KN., Kumar, V., et al.[2022]

Intensive occupational therapy (AOT) significantly improved rehabilitation outcomes for patients with acute stroke, leading to better Functional Independence Measure (FIM) and National Institutes of Health Stroke Scale (NIHSS) scores, and reduced hospitalization time.

The study, which analyzed data from 3,501 stroke patients, found that AOT was particularly beneficial for those with severe limitations in daily activities and cognitive impairments, suggesting that more intensive therapy can lead to greater improvements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study. Yamakawa, S., Nagayama, H., Tomori, K., et al.[2023]

The study involved 11 stroke patients and demonstrated that using a two-dimensional myoelectric-controlled interface (MCI) significantly improved inter-muscular coordination by reducing antagonist muscle activation and increasing cortical engagement during tasks.

A case study of a stroke patient undergoing 20 days of MCI-based training showed a notable reduction in muscle activation and an increase in cortical activation, suggesting that this training can help restore coordination and promote cortical reorganization in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating and restoring inter-muscular coordination in stroke patients using two-dimensional myoelectric computer interface: a cross-sectional and longitudinal study. Jian, C., Deng, L., Liu, H., et al.[2022]

Using a standardized set of outcome measures for assessing balance and mobility in stroke patients can improve treatment planning and ensure consistency across different healthcare settings.

The article provides a case-based approach to selecting the most effective measures based on the International Classification of Functioning, Disability and Health (ICF) model, which can help healthcare professionals navigate the many available options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting measures for balance and mobility to improve assessment and treatment of individuals after stroke. Kegelmeyer, DA., Kloos, AD., Siles, AB.[2016]

In a study involving 20 chronic stroke patients, a three-week gait-oriented physiotherapy program provided a total of 19 hours of instructed therapy and 28 hours of self-initiated training, emphasizing the importance of active practice in rehabilitation.

The combination of various training methods, including electromechanical gait trainers and self-initiated exercises, led to significant improvements in gait ability, highlighting the effectiveness of structured and diverse rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? Peurala, SH., Pitkänen, K., Sivenius, J., et al.[2016]

An ethnographic study involving 43 participants across three English hospitals revealed significant variability in how stroke therapy time was recorded and how therapists decided which patients were appropriate for therapy, indicating inconsistencies in service delivery.

Therapists expressed skepticism about the validity of audit results, feeling that these metrics did not accurately reflect the quality of care provided, and patients desired more involvement in their treatment decisions, highlighting a gap between patient needs and therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is the audit of therapy intensity influencing rehabilitation in inpatient stroke units in the UK? An ethnographic study. Taylor, E., Jones, F., McKevitt, C.[2023]

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