[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633790":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":60,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":93,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Neuromuscular coordination enhancement (NICE) intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: EMG Amplitude Biofeedback Exercise",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"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).",[15],[30],{"name":31,"affiliation":5,"role":32},"Jinsook Roh, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","7137432578","jroh@Central.UH.EDU",[39],{"facility":5,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Houston","Texas","77045","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-95.36327,29.76328,{"lat":49,"lon":48},[52,56],{"name":53,"role":35,"phone":54,"phoneExt":24,"email":55},"JIN-SOOK ROH, PhD","6173680050","jsroh@central.uh.edu",{"name":31,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Jinsook Roh","Associate Professor",[61,63],{"name":62,"class":6},"TIRR Memorial Hermann",{"name":64,"class":6},"The University of Texas Health Science Center, Houston","100633790","early-phase-1-neuro-intermuscular-coordination-enhancement-nice-rehabilitation-through-human-machine-interaction-in-chronic-stroke-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":78,"type":79},48,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85,86],"Chronic Stroke-related Upper-extremity Motor Impairment","Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery",[88,89,90,91,92],"Muscle Synergy","Non-invasive Rehabilitation","Intermuscular Coordination","Stroke","Motor module","NOT_YET_RECRUITING","2026-06-15",{"date":96,"type":97},"2026-06-18","ACTUAL",{"date":99,"type":79},"2027-08",{"date":101,"type":79},"2032-08",{"name":5,"class":6},1]