[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053325":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":42,"studyPopulation":32,"armGroups":43,"interventions":60,"overallOfficials":86,"centralContacts":91,"locations":97,"responsibleParty":146,"collaborators":148,"id":151,"slug":32,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":32,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":32,"studyType":163,"phases":164,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":100,"whyStopped":32,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Fugl-Meyer Lower Extremity (FMLE)","The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.","At the beginning and end of 3-week training, and 1 month after the treatment ends]",[14,18,21,23,26,29],{"measure":15,"description":16,"timeFrame":17},"Active range of motion (AROM)","AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.","At the beginning and end of 3-week training, and 1 month after the treatment ends",{"measure":19,"description":20,"timeFrame":17},"Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.","Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.",{"measure":22,"description":22,"timeFrame":17},"Strength of the ankle flexor-extensor muscle will be measured in Newtons",{"measure":24,"description":25,"timeFrame":17},"Modified Ashworth Scale (MAS)","The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.",{"measure":27,"description":28,"timeFrame":17},"Berg Balance Scale","The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.",{"measure":30,"description":31,"timeFrame":17},"10-meter Walk Test","The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","Randomized clinical trial with the study group and control group","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR","Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.",[44,52],{"label":45,"type":46,"description":47,"interventionNames":48},"Study group - Wearable ankle robot rehab","EXPERIMENTAL","Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance",[49,50,51],"Device: Motor relearning training","Device: Passive stretching","Device: Gamed-based active movement training",{"label":53,"type":54,"description":55,"interventionNames":56},"Control group - Limited wearable ankle robot rehab","ACTIVE_COMPARATOR","The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance",[57,58,59],"Device: Passive movement","Device: Active movement training","Device: Ankle torque and motion measurement",[61,66,70,74,78,82],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":32},"DEVICE","Motor relearning training","Ankle motor control relearning training under real-time feedback",[45],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":32},"Passive stretching","Passive stretching under intelligent robotic control",[45],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":32},"Gamed-based active movement training","Active movement training through movement games with robotic assistance",[45],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":32},"Passive movement","Passive movement in the joint middle range of motion",[53],{"type":62,"name":79,"description":80,"armGroupLabels":81,"otherNames":32},"Active movement training","Active movement training without robotic assistance",[53],{"type":62,"name":83,"description":84,"armGroupLabels":85,"otherNames":32},"Ankle torque and motion measurement","Ankle torque and motion measurement with no real-time feedback",[53],[87],{"name":88,"affiliation":89,"role":90},"Li-Qun Zhang","University of Maryland","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":32,"email":96},"Peiwen Fu, BS","CONTACT","410 706-8625","Peiwen.Fu@som.umaryland.edu",[98,118,129],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"University of Maryland Baltimore","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-76.61219,39.29038,{"lat":110,"lon":109},[113,115,116],{"name":114,"role":94,"phone":32,"phoneExt":32,"email":32},"Dali Xu, PhD",{"name":93,"role":94,"phone":32,"phoneExt":32,"email":32},{"name":117,"role":90,"phone":32,"phoneExt":32,"email":32},"Li-Qun Larry Zhang, PhD",{"facility":119,"status":100,"city":101,"state":102,"zip":120,"country":104,"countryCode":105,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"UMROI","21207",{"type":107,"coordinates":122},[109,110],{"lat":110,"lon":109},[125,127],{"name":126,"role":94,"phone":32,"phoneExt":32,"email":32},"Dali Xu",{"name":128,"role":94,"phone":32,"phoneExt":32,"email":32},"Peiwen Fu",{"facility":130,"status":100,"city":131,"state":132,"zip":133,"country":104,"countryCode":105,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"TIRR Memorial Hermann","Houston","Texas","77030",{"type":107,"coordinates":135},[136,137],-95.36327,29.76328,{"lat":137,"lon":136},[140,144],{"name":141,"role":94,"phone":142,"phoneExt":32,"email":143},"Manuel Portilla-Jimenez, PhD","346-719-4921","manuel.a.portillajimenez@uth.tmc.edu",{"name":145,"role":90,"phone":32,"phoneExt":32,"email":32},"Sheng Li, MD-PhD",{"type":90,"investigatorFullName":88,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Professor",[149],{"name":150,"class":6},"The University of Texas Health Science Center, Houston","100053325",false,"NCT06404268","Facilitating Neuroplastic Changes of Acute Stroke Survivors","Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia","Inclusion Criteria:\n\n* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)\n* Hemiplegia or hemiparesis\n* 0≤Manual Muscle Testing (MMT)\\\u003C=2\n* Age 30-85\n* Ankle impairments including stiff calf muscles and\u002For inadequate dorsiflexion\n\nExclusion Criteria:\n\n* Medically not stable\n* Associated acute medical illness that interferes with ability to training and exercise\n* No impairment or very mild ankle impairment of ankle\n* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises\n* Cognitive impairment or aphasia with inability to follow instructions\n* Severe pain in legs\n* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)\n* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee","ALL","30 Years","85 Years",{"count":161,"type":162},68,"ESTIMATED","INTERVENTIONAL",[165,166],"PHASE1","PHASE2","This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.",[169],"Stroke",[169,171,172],"Paraplegia","Acute","2026-07-10",{"date":175,"type":176},"2026-07-13","ACTUAL",{"date":178,"type":176},"2025-07-01",{"date":180,"type":162},"2028-12-31",{"name":5,"class":6},3]