[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07531264":3,"trial-entities:NCT07531264":160,"trial-summary:NCT07531264":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":44,"secondary_outcomes":49,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":100,"locations":103,"central_contacts":121,"overall_officials":125,"references":127,"see_also_links":156},"NCT07531264","STUDY00001333-NICE","Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke","Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation","NOT_YET_RECRUITING","2032-08","2026-06","2026-06-18","2027-08","University of Houston","OTHER",false,"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.","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.\n\nThis 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.\n\nForty-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.\n\nOutcomes 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.\n\nThe 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.",[19,20],"Chronic Stroke-related Upper-extremity Motor Impairment","Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery",[22,23,24,25,26],"Muscle Synergy","Non-invasive Rehabilitation","Intermuscular Coordination","Stroke","Motor module","INTERVENTIONAL","TREATMENT",[30],"EARLY_PHASE1",{"count":32,"type":33},48,"ESTIMATED",[35,39],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Neuromuscular coordination enhancement (NICE) intervention","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.\n\nParticipants will complete 18 one-hour training sessions over six weeks (3 sessions\u002Fweek). During training, participants perform repetitive target-matching tasks that require preferential recruitment of specific motor modules while minimizing unintended activation of non-target modules.",[36],{"type":14,"name":40,"description":41,"armGroupLabels":42},"EMG Amplitude Biofeedback Exercise","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\u002Fweek).",[43],"EMG-amplitude biofeedback exercise",[45],{"measure":46,"description":47,"timeFrame":48},"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.","Baseline, six- week, 10-week, and 18-week follow-ups.",[50,53,57,60,63,67,70,73],{"measure":51,"description":52,"timeFrame":48},"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.",{"measure":54,"description":55,"timeFrame":56},"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.","Baseline, six-week, 10-week, and 18-week follow-ups.",{"measure":58,"description":59,"timeFrame":48},"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.",{"measure":61,"description":62,"timeFrame":56},"Active range of motion","The active range of motion will be calculated from full active range tasks for shoulder flexion\u002Fextension, internal\u002Fexternal rotation, abduction\u002Fadduction, elbow flexion\u002Fextension, and wrist pronation\u002Fsupination. Kinematic joint positions and angles will be used to calculate the same.",{"measure":64,"description":65,"timeFrame":66},"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.","Baseline and six-week follow-up.",{"measure":68,"description":69,"timeFrame":66},"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.",{"measure":71,"description":72,"timeFrame":66},"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.",{"measure":74,"description":75,"timeFrame":66},"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).","ALL","21 Years","80 Years",true,{"inclusion":81,"exclusion":90,"raw_text":99},[82,83,84,85,86,87,88,89],"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",[91,92,93,94,95,91,96,97,98],"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 with known neurological disorders","Individuals with orthopedic injuries or conditions affecting upper-extremity movement","Individuals unable to provide informed consent","Inclusion criteria for individuals after stroke are:\n\n* Hemiparetic chronic stroke survivors more than 6 months after stroke onset\n* Adults aged 21-80 years, including both female and male participants\n* Individuals with a single unilateral ischemic or hemorrhagic stroke\n* Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66\n* Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months\n* Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder\n\nExclusion criteria for individuals after stroke are:\n\n* Individuals younger than 21 years of age or older than 80 years of age\n* Individuals with an orthopedic disorder involving the upper limbs\n* Individuals unable to produce voluntary upper-extremity muscle EMG activity;\n* 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.\n* Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score \\>0.80 relative to the non-affected arm\n\nInclusion criteria for healthy individuals are:\n\n* Healthy adults aged 21-80 years, including both female and male participants\n* Individuals with no known neurological or orthopedic injuries\n\nExclusion criteria for healthy individuals are:\n\n* Individuals younger than 21 years of age or older than 80 years of age\n* Individuals with known neurological disorders\n* Individuals with orthopedic injuries or conditions affecting upper-extremity movement\n* Individuals unable to provide informed consent",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":13,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":118},"Houston","Texas","77045","United States",[110,115],{"name":111,"role":112,"phone":113,"email":114},"JIN-SOOK ROH, PhD","CONTACT","6173680050","jsroh@central.uh.edu",{"name":116,"role":117},"Jinsook Roh, PhD","PRINCIPAL_INVESTIGATOR",{"lat":119,"lon":120},29.76328,-95.36327,[122],{"name":116,"role":112,"phone":123,"email":124},"7137432578","jroh@Central.UH.EDU",[126],{"name":116,"affiliation":13,"role":117},[128,132,135,138,141,144,147,150,153],{"pmid":129,"type":130,"citation":131},"35778757","BACKGROUND","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\u002Fs12984-022-01045-z.",{"pmid":133,"type":130,"citation":134},"37895442","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\u002Flife13102061.",{"pmid":136,"type":130,"citation":137},"21653716","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\u002Fjn.00842.2010. Epub 2011 Jun 8.",{"pmid":139,"type":130,"citation":140},"14523747","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\u002FWA7K-NGDF-NHKK-JAGD.",{"pmid":142,"type":130,"citation":143},"31199248","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\u002FTBME.2019.2921766. Epub 2019 Jun 13.",{"pmid":145,"type":130,"citation":146},"30402139","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\u002F2018\u002F5637568. eCollection 2018.",{"pmid":148,"type":130,"citation":149},"38082751","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\u002FEMBC40787.2023.10339985.",{"pmid":151,"type":130,"citation":152},"40031505","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\u002FEMBC53108.2024.10782001.",{"pmid":154,"type":130,"citation":155},"37658406","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\u002Fs12984-023-01236-2.",[157],{"label":158,"url":159},"Laboratory Webpage","https:\u002F\u002Fwww.reignlaboratory.com\u002Fprojects-3",{"nct_id":4,"conditions":161,"biomarkers":162},[25],[],{"nct_id":4,"found":79,"summary":164,"prompt_version":174},{"design":165,"status":166,"heading":167,"summary":168,"follow_up":169,"word_count":170,"commitments":171,"compensation":172,"drugs_mentioned":173},"This is an early-stage, randomized controlled rehabilitation trial. Forty-eight participants will be enrolled and assigned to either the NICE intervention or EMG Amplitude Biofeedback Exercise.","completed","Neuro-Intermuscular Coordination Enhancement (NICE) for Chronic Stroke","This study is testing a new rehabilitation approach called Neuro-Intermuscular Coordination Enhancement (NICE) for people with chronic stroke who have difficulty moving their arm or hand. NICE uses a human-machine interaction to help retrain how your muscles work together. It will be compared to another rehabilitation method called EMG Amplitude Biofeedback Exercise, which focuses on targeted muscle activation. The goal is to see if NICE can improve your arm and hand movement, leading to a better quality of life. You might be able to join if you are 21-80 years old, had a stroke more than 6 months ago, and have certain levels of arm and hand weakness. The study aims to enroll 48 participants, but its current status is unclear.","Your arm and hand function will be followed for 18 weeks after the start of the study.",121,"You would receive interventions three times per week for six weeks, totaling 18 sessions. Your arm and hand function will be measured at the start, six weeks, 10 weeks, and 18 weeks.","Not stated in the trial record.",[40],"v2"]