[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431381":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":36,"locations":45,"responsibleParty":67,"collaborators":69,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Teachers College, Columbia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic Trunk-Support-Trainer (TruST)","EXPERIMENTAL","Postural-reaching control intervention with TruST",[13],"Device: Robotic Trunk-Support-Trainer (TruST)",{"label":15,"type":16,"description":17,"interventionNames":18},"Static Trunk Support","ACTIVE_COMPARATOR","Postural-reaching control intervention with Rigid Trunk Support",[19],"Device: Static Trunk Support",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.\n\n\\- Twelve 2hr training sessions (3 times per week for 4 weeks)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.\n\n\\- Twelve 2hr training sessions (3 times per week for 4 weeks)",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Sunil Agrawal, PhD","Columbia University","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Andrew Gordon, PhD",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Victor Santamaria, PT, PhD","CONTACT","212.678.3332","vs2578@columbia.edu",{"name":43,"role":39,"phone":40,"phoneExt":25,"email":44},"Karen Chin, MA","cpresearch@tc.columbia.edu",[46,61],{"facility":32,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","New York","10027","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59],{"name":38,"role":39,"phone":60,"phoneExt":25,"email":41},"212-678-3332",{"facility":5,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},{"type":53,"coordinates":63},[55,56],{"lat":56,"lon":55},[66],{"name":43,"role":39,"phone":60,"phoneExt":25,"email":44},{"type":68,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[70],{"name":32,"class":6},"100431381","robotic-trust-postural-intervention-for-children-with-cerebral-palsy-100431381",false,"NCT04897347","Robotic TruST-Postural Intervention for Children With Cerebral Palsy","Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 6-17 years\n* Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia\n* Gross Motor Function Classification Systems-Expanded \\& Review (GMFCS) levels III or IV\n* Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)\n* Cognitive capacity to follow basic verbal instructions (i.e., \"do not put your hands on your lap\" or \"follow and reach the toy\")\n\nExclusion Criteria:\n\n* Absent head control (SATCo = 1)\n* Current medical illness unrelated to CP at the time of the study\n* Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements\n* History of recurrent seizures (daily) or drug-resistance epilepsy\n* Severe Spinal Deformities: scoliosis \\>40◦ and\u002For kyphosis \\>45◦\n* Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months\n* Severe spasticity of biceps\u002Ftriceps in both upper extremities (Modified Ashworth Scale = 4)\n* Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study\n* Other major surgeries in the previous 6 months (if medically contraindicated)","ALL","6 Years","17 Years",{"count":82,"type":83},82,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).",[89],"Cerebral Palsy",[91,92,93,94,95],"Posture","Reaching","Robotics","Motor Learning","Motor Control","2023-12-21",{"date":98,"type":99},"2023-12-22","ACTUAL",{"date":101,"type":99},"2022-02-26",{"date":103,"type":83},"2027-06",{"name":5,"class":6},2]