[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656309":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":82,"studyPopulation":73,"armGroups":83,"interventions":95,"overallOfficials":105,"centralContacts":110,"locations":119,"responsibleParty":138,"collaborators":73,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":73,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":122,"whyStopped":73,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"University Hospital of Mont-Godinne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":73},[9,13,17,20,24,27],{"measure":10,"description":11,"timeFrame":12},"Unimanual\u002Fbimanual Speed\u002FAccuracy Trade-off (SAT\u002Fbi-SAT) measured by the REAplan® robot","Unimanual\u002Fbimanual Speed\u002FAccuracy Trade-off: mathematical computation of the relationship between speed and accuracy, in arbitrary units (SAT = speed (cm\u002Fs)\u002Ferror (cm²).C, where C=1cm.s)","Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode",{"measure":14,"description":15,"timeFrame":16},"bimanual Coordination factor (bi-CO) measured by the REAplan® robot","bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms","change between baseline (Day 1) and after training (Day 3)",{"measure":18,"description":19,"timeFrame":16},"bi-Force, bimanual force measured by the REAplan® robot","bimanual forces, forces exerted in the wrong direction by each arm (Newtons)",{"measure":21,"description":22,"timeFrame":23},"Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain® Manipulandum","tracking error between the optimal trajectory between 2 targets and the actual trajectory","change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode",{"measure":25,"description":26,"timeFrame":16},"bimanual Coordination factor (bi-CO) measured by the Dextrain(R) Manipulandum","bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both hands",{"measure":28,"description":29,"timeFrame":23},"Hold time measured by the Dextrain® Manipulandum","The amount of time the cursor remains inside the target zone",[31,34,38,41,45,48,51,55,58,62,66,69],{"measure":32,"description":33,"timeFrame":23},"Coactivation measured by the Dextrain Manipulandum","binary measure of unasked fingers activated above the force threshold",{"measure":35,"description":36,"timeFrame":37},"Voxel-based Lesion Symptom Mapping (VLSM)","Diffusion Weighted Imaging (DWI)","Baseline",{"measure":39,"description":40,"timeFrame":37},"Diffusion Tensor Imaging (DTI)","Fractional Anisotrophy, Mean\u002FAxial\u002FRadial Diffusivity",{"measure":42,"description":43,"timeFrame":44},"Fugl Meyer Upper Extremity (FMA-UE)","Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment","Day1",{"measure":46,"description":47,"timeFrame":44},"Box and Block test","Measures unilateral gross dexterity by moving as many small wooden blocks as possible from one side to the other side of the box within 60 seconds. The task is performed seperately with each hand. Score range: 0-150 for each hand. The score corresponds to the number of blocks successfully transferred in one minute. A higher score indicates better gross manual dexterity and upper-limb function.",{"measure":49,"description":50,"timeFrame":44},"Purdue Pegboard Test","Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks",{"measure":52,"description":53,"timeFrame":54},"Oxford Cognitive Screen","A first-line, stroke-specific and domain-specific cognitive screening tool, inclusive for patients with aphasia and neglect. Domains assessed: Language, Praxis, Number, Memory, Spatial and Controlled Attention. It provides a cognitive profile showing both preserved and impaired abilities","Day2",{"measure":56,"description":57,"timeFrame":54},"Key WAIS IV","A paper-pen test to asses processing speed and working memory.",{"measure":59,"description":60,"timeFrame":61},"Fatigue Visual Analog Scale","A psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10. A higher score means a higher level of fatigue.","Every days, mean of the three days",{"measure":63,"description":64,"timeFrame":65},"Shoulder Abduction Finger Extension (SAFE) test","A prognostic determinant of the function of the hemiparetic upper limb (UL) after a stroke. For each of the 2 subitems, the range is 0-5. A score of 5 means normal power. A score of 0 means no contraction possible.","Day 1",{"measure":67,"description":68,"timeFrame":65},"Modified Ashworth Scale (mAS)","clinical measure of spasticity. For each of the 8 subitems, the range is 0-4. A higher score means a higher level of spasticity",{"measure":70,"description":71,"timeFrame":72},"Intrinsic Motivation Inventory","The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments","Day 3",null,{"allocation":75,"interventionModel":76,"interventionModelDescription":73,"primaryPurpose":77,"observationalModel":73,"timePerspective":73,"maskingInfo":78},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":79,"maskingDescription":73,"whoMasked":80},"SINGLE",[81],"PARTICIPANT","Over 3 consecutive days, healthy individuals, acute and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabiliation robot REAplan® and Dextrain® device.\n\nThey will practice a task on the robot REAplan® (unimanual or bimanual version), requiring movements with the affected arm (unimanual version) and complex, coordinated movements with both arms (bimanual version). They will practice another task on the Dextrain® device, also in unimanual and bimanual version.\n\nIn addition, several standardized clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...)",[84,91],{"label":85,"type":86,"description":87,"interventionNames":88},"Bimanual tasks","EXPERIMENTAL","Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the bimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a bimanual version of the Targeting task.",[89,90],"Device: REAplan®","Device: Dextrain® Manipulandum",{"label":92,"type":86,"description":93,"interventionNames":94},"Unimanual tasks","Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the unimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a unimanual version of the Targeting task.",[89,90],[96,101],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":73},"DEVICE","REAplan®","motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms",[85,92],{"type":97,"name":102,"description":103,"armGroupLabels":104,"otherNames":73},"Dextrain® Manipulandum","motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands",[85,92],[106],{"name":107,"affiliation":108,"role":109},"Yves Vandermeeren, MD, PhD","UCLouvain IoNS","PRINCIPAL_INVESTIGATOR",[111,115],{"name":107,"role":112,"phone":113,"phoneExt":73,"email":114},"CONTACT","+32 (0)81 42 33 21","yves.vandermereen@uclouvain.be",{"name":116,"role":112,"phone":117,"phoneExt":73,"email":118},"Laura Santelé, MSc","+32 (0)81 42 34 91","laura.santele@uclouvain.be",[120],{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"CHU UCL Namur","RECRUITING","Yvoir","Namur","5530","Belgium","BE",{"type":129,"coordinates":130},"Point",[131,132],4.88059,50.3279,{"lat":132,"lon":131},[135,136],{"name":116,"role":112,"phone":117,"phoneExt":73,"email":118},{"name":107,"role":112,"phone":113,"phoneExt":73,"email":137},"yves.vandermeeren@uclouvain.be",{"type":109,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":73,"oldOrganization":73},"Pr Yves Vandermeeren, MD, PhD","MD, PhD, Neurologist, Principal Investigator, Clinical Professor","100656309","unimanual-versus-bimanual-motor-skill-learning-in-acute-and-chronic-stroke-100656309",false,"NCT07826832","Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke","Comparison of Unimanual Versus Bimanual Motor Skill Learning (Proximal and Distal) After Stroke by Means of Robotics (REA²Plan® and Dextrain®) and Multimodal Brain Imaging (VLSM, DTI, NODDI, DIAMOND)","MLAS6","STROKE PATIENTS\n\nInclusion Criteria:\n\n* acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (\\>6 mois)\n* aged 40-90 years\n* with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging\n\nExclusion Criteria:\n\n* \\[for acute paitents\\] \"classical\" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)\n* difficulty in understanding or executing commands\n* drug\u002Falcohol abuse\n* severe aphasia\u002Fcognitive deficits interfering with study\n* inability to complete the tasks (i.e. full paralysis of the arm)\n* multiple stroke\u002Fdementia\u002Fpsychiatric condition\n\nHEALTHY INDIVIDUALS\n\nInclusion Criteria:\n\n* 40-90 years\n\nExclusion Criteria:\n\n* \"classical\" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)\n* medical history with a previous stroke\u002Frelevant neurological deficit\n* drug\u002Falcohol abuse\n* psychiatric condition\u002Fdementia\n* having already used the robotic devices",true,"ALL","40 Years","90 Years",{"count":154,"type":155},200,"ESTIMATED","INTERVENTIONAL",[158],"NA","To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device. The goals are (1) to compare head-to-head bimanual versus unimanual motor learning (in the proximal and distal upper limb, UL) during the acute - early subactue stage of stroke with robotics and (2) to identify the neural substrates associated with (and deficits in) unimanual versus bimanual motor control (proximal and distal) after stroke by means of multimodal brain imaging.",[161,162,163,164],"Acute Stroke","Chronic Stroke Patient","Healthy Individuals (Controls)","Stroke (Subacute)",[166,167,161,168,169,170,171,172],"Motor Skill Learning","Upper Limb","Chronic Stroke","Rehabilitation","Subacute stroke","Robotics","MRI","2026-09-14",{"date":175,"type":176},"2026-09-17","ACTUAL",{"date":178,"type":176},"2026-05-18",{"date":180,"type":155},"2031-12-31",{"name":5,"class":6},1]