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Chronic Stroke-related Upper-extremity Motor ImpairmentEarly Phase 1NICENCT07531264

Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke

A Early Phase 1 study testing Neuromuscular coordination enhancement (NICE) intervention and EMG Amplitude Biofeedback Exercise in people with Chronic Stroke-related Upper-extremity Motor Impairment and Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery, run by University of Houston at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate motor modules through human-machine interaction. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
What is being tested?
Neuromuscular coordination enhancement (NICE) intervention and EMG Amplitude Biofeedback Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Aug 2027to Aug 2032
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Hemiparetic chronic stroke survivors more than 6 months after stroke onset
  • Adults aged 21-80 years, including both female and male participants
  • Individuals with a single unilateral ischemic or hemorrhagic stroke
  • Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66
  • Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months
  • Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder
  • Healthy adults aged 21-80 years, including both female and male participants
  • Individuals with no known neurological or orthopedic injuries

Who cannot join

  • Individuals younger than 21 years of age or older than 80 years of age
  • Individuals with an orthopedic disorder involving the upper limbs
  • Individuals unable to produce voluntary upper-extremity muscle EMG activity;
  • Individuals with cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol, assessed using the Montreal Cognitive Assessment or other IRB-approved screening procedures.
  • Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score >0.80 relative to the non-affected arm
  • Individuals younger than 21 years of age or older than 80 years of age
Show all 9Show fewer
  • Individuals with known neurological disorders
  • Individuals with orthopedic injuries or conditions affecting upper-extremity movement
  • Individuals unable to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinsook Roh, PhD contact

7137432578

jroh@Central.UH.EDU

United States1 site
  • University of Houston

    Houston, Texas, 77045

    JIN-SOOK ROH, PhD, 6173680050, jsroh@central.uh.edu

    Jinsook Roh, PhD

Other trials in United States

About this study

Official title: Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation

The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate motor modules through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.

Read the detailed description

Stroke is the leading cause of severe long-term disability, affecting 9.4 million Americans. Each year around 800,000 people suffer a stroke even in the USA. Chronic upper extremity motor impairment is a major contributing factor to disability; functional use of the affected UE in daily life is a key factor for increased independence, return to work, and overall quality of life. Thus, effective and innovative treatment to address long-term disability is both a major public health need and an economic necessity.

This study is an early-stage, randomized controlled rehabilitation trial designed to evaluate the clinical effects, feasibility, transfer of therapeutic gains, and exploratory neurophysiological correlates of Neuro-Intermuscular Coordination Enhancement (NICE) in individuals with chronic stroke and upper-extremity hemiparesis.

Forty-eight participants will be enrolled to obtain a target analyzable sample of 40 participants. Eligible participants will be randomized to either: (1) NICE, a motor module-guided rehabilitation intervention using isometric human-machine interaction and real-time EMG-based visual feedback to retrain impaired intermuscular coordination patterns; or (2) an active comparator consisting of dose-matched EMG amplitude biofeedback exercise. Both interventions will be delivered three times per week for six weeks (18 total sessions). Participants will complete assessments at baseline, immediately post-intervention, and at 10- and 18-week follow-up time points.

Outcomes will include standardized clinical measures of upper-extremity motor impairment and function, measures of intermuscular coordination derived from surface electromyography, kinematic measures obtained during untrained dynamic motor tasks, and EEG-based measures of brain activity and connectivity.

The primary objective is to determine whether NICE improves upper-extremity motor impairment relative to the active comparator. Secondary objectives are to evaluate intervention-related changes in intermuscular coordination and transfer of therapeutic gains to untrained motor behaviors. Exploratory objectives are to characterize rehabilitation-associated neurophysiological changes and examine relationships among EEG-derived biomarkers, intermuscular coordination, and clinical recovery outcomes.

Being tested
Neuromuscular coordination enhancement (NICE) intervention, EMG Amplitude Biofeedback Exercise
Keywords
Muscle Synergy, Non-invasive Rehabilitation, Intermuscular Coordination, Stroke, Motor module
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular coordination enhancement (NICE) interventionOther

    Neuro-Intermuscular Coordination Enhancement (NICE) is a motor module-guided rehabilitation intervention designed to improve upper-extremity motor recovery after stroke by retraining impaired intermuscular coordination patterns. Participants perform isometric upper-extremity force-generation tasks using a human-machine interface while receiving real-time visual feedback derived from motor module recruitment signals calculated from surface electromyography (EMG). Individualized motor module targets are derived from the participant's less-affected upper extremity and used to guide selective recruitment of impaired coordination patterns in the more-affected upper extremity.

    Participants will complete 18 one-hour training sessions over six weeks (3 sessions/week). During training, participants perform repetitive target-matching tasks that require preferential recruitment of specific motor modules while minimizing unintended activation of non-target modules.

  • EMG Amplitude Biofeedback ExerciseOther

    EMG Amplitude Biofeedback Exercise is an active comparator rehabilitation intervention designed to improve upper-extremity motor function after stroke through targeted muscle activation training. Participants perform isometric upper-extremity exercises using a human-machine interface with real-time EMG amplitude-based visual feedback. Individualized muscle activation targets derived from the less-affected upper extremity guide training of the more-affected upper extremity. Participants will complete 18 one-hour sessions over 6 weeks (3 sessions/week).

Study groups in NCT07531264
Study groupRoleWhat they receive
Neuromuscular coordination enhancement (NICE) interventionExperimentalPost-stroke participants will perform a center-out task by activating individual motor modules (generating coordinated isometric contractions of muscles) to move the cursor on a screen while electromyographic (EMG) signals 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 Motor module activation magnitudes recorded from arm muscles.
Receives: Other: Neuromuscular coordination enhancement (NICE) intervention
EMG-amplitude biofeedback exerciseActive comparatorParticipants will perform a center-out target matching tasks where individual muscle EMGs are used to move a cursor on the visual feedback display to match one of 4 different targets presented to them. Here, just the EMG amplitude, and not the coordination is focused on.
Receives: Other: EMG Amplitude Biofeedback Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment (FMA) score

    Motor impairment after stroke will be measured by upper extremity FMA (UE-FMA). The maximum UE-FMA motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance). Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The FMA score reflects the level of upper extremity motor impairment.

    Measured: Baseline, six- week, 10-week, and 18-week follow-ups.

Secondary outcomes (8)
  1. Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)

    Surface EMGs will be recorded from 8 key arm muscles during a 54-target isometric force generation task. A dimensionality reduction method (non-negative matrix factorization (NNMF)) will be applied to identify intermuscular coordination patterns - operational definition of motor modules in the field of motor neuroscience. They are mathematically 8-dimensional unit vectors. Similarity score is the scalar product (or dot product) between a pair of intermuscular coordination patterns in comparison (i.e., motor modules). We compute the similarity score between the less-affected and the more-affected arms. Also, surface EMGs will be recorded from 8 key arm muscles during 3D dynamic reaching tasks. NNMF will be applied to EMGs to identify and compare intermuscular coordination patterns. Similarity score is the scalar product between motor modules (i.e., intermuscular coordination patters) of the more-affected arm in stroke group and dominant arm in healthy group.

    Measured: Baseline, six- week, 10-week, and 18-week follow-ups.

  2. Kinematic Synergy Similarity Score

    Kinematic synergies are a representation of multi-joint coordination. It will be identified using NNMF algorithm applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching tasks. Kinematic synergy similarity between stroke and healthy will be calculated using their scalar product.

    Measured: Baseline, six-week, 10-week, and 18-week follow-ups.

  3. Pairwise joint angle-to-angle correlation value

    Pairwise joint angle-to-angle correlation is a way to see the joint coupling using kinematic data. It will be calculated using Pearson's correlation coefficient between joint angles during the point-to-point reaching task.

    Measured: Baseline, six- week, 10-week, and 18-week follow-ups.

  4. Active range of motion

    The active range of motion will be calculated from full active range tasks for shoulder flexion/extension, internal/external rotation, abduction/adduction, elbow flexion/extension, and wrist pronation/supination. Kinematic joint positions and angles will be used to calculate the same.

    Measured: Baseline, six-week, 10-week, and 18-week follow-ups.

  5. EEG Spectral power ratios

    EEG-derived spectral power ratios will be calculated, in resting and task conditions, across different frequency bands (delta, theta, alpha, beta, gamma) and different events (onset, successful match, etc.) across four different directions of target match.

    Measured: Baseline and six-week follow-up.

  6. EEG-derived Brain Symmetry Index

    The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.

    Measured: Baseline and six-week follow-up.

  7. Cortico-muscular connectivity

    Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG and EMG signals in the desired brain region and muscle activation associated with directional 4-target isometric force generation.

    Measured: Baseline and six-week follow-up.

  8. Cortico-cortical connectivity

    Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG signals from different regions of interest (sources, e.g., ipsi and contralesional fronto-parietal regions, primary motor cortex and somatosensory cortices).

    Measured: Baseline and six-week follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study startAug 2027 (estimated)
  3. Primary completionAug 2032 (estimated)
  4. Study completionAug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an early-stage, randomized controlled rehabilitation trial where behavioral intervention through human-machine interaction will be performed on stroke survivors.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531264
Sponsor's protocol ID
STUDY00001333-NICE
Acronym
NICE
Status last verified
Jun 2026
First submitted
22 Oct 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.

    PubMed 35778757
  • Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.

    PubMed 37895442
  • Roh J, Cheung VC, Bizzi E. Modules in the brain stem and spinal cord underlying motor behaviors. J Neurophysiol. 2011 Sep;106(3):1363-78. doi: 10.1152/jn.00842.2010. Epub 2011 Jun 8.

    PubMed 21653716
  • Dewald JP, Sheshadri V, Dawson ML, Beer RF. Upper-limb discoordination in hemiparetic stroke: implications for neurorehabilitation. Top Stroke Rehabil. 2001 Spring;8(1):1-12. doi: 10.1310/WA7K-NGDF-NHKK-JAGD.

    PubMed 14523747
  • Nordin AD, Hairston WD, Ferris DP. Faster Gait Speeds Reduce Alpha and Beta EEG Spectral Power From Human Sensorimotor Cortex. IEEE Trans Biomed Eng. 2020 Mar;67(3):842-853. doi: 10.1109/TBME.2019.2921766. Epub 2019 Jun 13.

    PubMed 31199248
  • Roh J, Beer RF, Lai A, Rho M, Karvelas KR, Nader AM, Kendall MC, Rymer WZ. The Effects of Selective Muscle Weakness on Muscle Coordination in the Human Arm. Appl Bionics Biomech. 2018 Sep 19;2018:5637568. doi: 10.1155/2018/5637568. eCollection 2018.

    PubMed 30402139
  • Park JH, Lee H, Kwon HJ, Shin JH, Roh J, Park HS. Feasibility of Isokinetic Training to Modify Coupling of Upper Limb Muscle Synergy Activation in Stroke-affected Upper Limb. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10339985.

    PubMed 38082751
  • Portilla-Jimenez M, Seo G, Houston M, Hong YNG, Li S, Park HS, Zhang Y, Roh J. Improving impaired intermuscular coordination after stroke through synergy-guided human-machine interaction: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2024 Jul;2024:1-4. doi: 10.1109/EMBC53108.2024.10782001.

    PubMed 40031505
  • Seo G, Park JH, Park HS, Roh J. Developing new intermuscular coordination patterns through an electromyographic signal-guided training in the upper extremity. J Neuroeng Rehabil. 2023 Sep 1;20(1):112. doi: 10.1186/s12984-023-01236-2.

    PubMed 37658406

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Neuromuscular coordination enhancement (NICE) intervention and EMG Amplitude Biofeedback Exercise in people with Chronic Stroke-related Upper-extremity Motor Impairment and Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery, run by University of Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinsook Roh, PhD (7137432578, jroh@Central.UH.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment (FMA) score (time frame: Baseline, six- week, 10-week, and 18-week follow-ups.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07531264, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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