[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633790":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":90,"studyPopulation":83,"armGroups":91,"interventions":104,"overallOfficials":112,"centralContacts":116,"locations":121,"responsibleParty":140,"collaborators":143,"id":148,"slug":83,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":83,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":175,"whyStopped":83,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"University of Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14,17,21,24,27,31,34,37],{"measure":15,"description":16,"timeFrame":12},"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":18,"description":19,"timeFrame":20},"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":22,"description":23,"timeFrame":12},"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":25,"description":26,"timeFrame":20},"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":28,"description":29,"timeFrame":30},"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":32,"description":33,"timeFrame":30},"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":35,"description":36,"timeFrame":30},"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":38,"description":39,"timeFrame":30},"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).",[41,45,49,52,55,58,61,65,68,72,75],{"measure":42,"description":43,"timeFrame":44},"Participant recruitment rate","Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period. This is a feasibility outcome.","From participant recruitment beginning to enrollment completion",{"measure":46,"description":47,"timeFrame":48},"Participant intervention adherence","Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant. This is a feasibility outcome.","Throughout the 6-week intervention period.",{"measure":50,"description":51,"timeFrame":48},"Participant Tolerance of the Intervention","Participant tolerance will be measured as the number and percentage of participants who complete intervention sessions without stopping due to discomfort, fatigue, pain, or other intolerance-related reasons. This is a feasibility outcome.",{"measure":53,"description":54,"timeFrame":48},"Intervention fidelity","Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol. This is a feasibility outcome.",{"measure":56,"description":57,"timeFrame":48},"Dose equivalence between the intervention groups","Dose equivalence will be assessed by comparing total intervention dose between groups, measured as total minutes of training and\u002For number of completed sessions per participant. This is a feasibility outcome.",{"measure":59,"description":60,"timeFrame":48},"NICE-specific training feasibility","NICE-specific feasibility will be assessed as the percentage of NICE intervention sessions in which the NICE training system\u002Fprotocol is successfully implemented as intended. This is a feasibility outcome.",{"measure":62,"description":63,"timeFrame":64},"Participant retention rate","Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment. This is a feasibility outcome.","Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.",{"measure":66,"description":67,"timeFrame":64},"Successful acquisition of study data","Successful data acquisition will be calculated as the percentage of expected EMG, EEG, kinematic, and clinical outcome datasets successfully collected and usable for analysis. This is a feasibility outcome.",{"measure":69,"description":70,"timeFrame":71},"Box and Block Test (BBT) score","The gross manual dexterity and upper extremity coordination will be assessed through BBT, which involves transfer of blocks from one compartment of a box to the other within 60 seconds. The score is the number of blocks successfully transferred to the other side within 60 seconds.","Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.",{"measure":73,"description":74,"timeFrame":71},"Modified Ashworth Scale (MAS) score","The increase in muscle tone will be assessed through MAS around the elbow and shoulder. MAS score ranges from 0 to 5. The MAS score reflects the severity of muscle spasticity.",{"measure":76,"description":77,"timeFrame":71},"Wolf Motor Function Test (WMFT) score","Motor function will be assessed through WMFT, which evaluates both the time and quality of performance across 17 tasks that range from simple joint movements to complex functional activities (like lifting a can or folding a towel). Performance Time (sec) is measured, with a maximum time limit (usually 120 seconds). Functional Ability Scale rates the quality of movement, using a 6-point ordinal scale (0 = Does not attempt with the involved arm, 1 = Attempted but cannot complete task, 2 = Completes task with great difficulty or poor movement quality, 3 = Completes task with moderate difficulty or noticeable impairment, 4 = Completes task with minor difficulty or near-normal movement, 5 = Normal movement quality and speed). The WMFT score assesses upper extremity motor function.",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":83,"timePerspective":83,"maskingInfo":84},"RANDOMIZED","PARALLEL","This is an early-stage, randomized controlled rehabilitation trial where behavioral intervention through human-machine interaction will be performed on stroke survivors.","TREATMENT",null,{"masking":85,"maskingDescription":83,"whoMasked":86},"TRIPLE",[87,88,89],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","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.",[92,98],{"label":93,"type":94,"description":95,"interventionNames":96},"Neuromuscular coordination enhancement (NICE) intervention","EXPERIMENTAL","Post-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.",[97],"Other: Neuromuscular coordination enhancement (NICE) intervention",{"label":99,"type":100,"description":101,"interventionNames":102},"EMG-amplitude biofeedback exercise","ACTIVE_COMPARATOR","Participants 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.",[103],"Other: EMG Amplitude Biofeedback Exercise",[105,108],{"type":6,"name":93,"description":106,"armGroupLabels":107,"otherNames":83},"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.",[93],{"type":6,"name":109,"description":110,"armGroupLabels":111,"otherNames":83},"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).",[99],[113],{"name":114,"affiliation":5,"role":115},"Jinsook Roh, PhD","PRINCIPAL_INVESTIGATOR",[117],{"name":114,"role":118,"phone":119,"phoneExt":83,"email":120},"CONTACT","7137432578","jroh@Central.UH.EDU",[122],{"facility":5,"status":83,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"Houston","Texas","77045","United States","US",{"type":129,"coordinates":130},"Point",[131,132],-95.36327,29.76328,{"lat":132,"lon":131},[135,139],{"name":136,"role":118,"phone":137,"phoneExt":83,"email":138},"JIN-SOOK ROH, PhD","6173680050","jsroh@central.uh.edu",{"name":114,"role":115,"phone":83,"phoneExt":83,"email":83},{"type":115,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":83,"oldOrganization":83},"Jinsook Roh","Associate Professor",[144,146],{"name":145,"class":6},"TIRR Memorial Hermann",{"name":147,"class":6},"The University of Texas Health Science Center, Houston","100633790",false,"NCT07531264","Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke","Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation","NICE","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",true,"ALL","21 Years","80 Years",{"count":160,"type":161},48,"ESTIMATED","INTERVENTIONAL",[164],"EARLY_PHASE1","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.",[167,168],"Chronic Stroke-related Upper-extremity Motor Impairment","Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery",[170,171,172,173,174],"Muscle Synergy","Non-invasive Rehabilitation","Intermuscular Coordination","Stroke","Motor module","NOT_YET_RECRUITING","2026-06-15",{"date":178,"type":179},"2026-06-18","ACTUAL",{"date":181,"type":161},"2027-08",{"date":183,"type":161},"2032-08",{"name":5,"class":6},1]