[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540885":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":11,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Wiktor Dega University Orthopedic and Rehabilitation Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotically Assisted Locomotion","EXPERIMENTAL",null,[13],"Procedure: Robotically Assisted Locomotion",{"label":15,"type":16,"description":11,"interventionNames":17},"Robotically Assisted Verticalization","ACTIVE_COMPARATOR",[18],"Procedure: Robotically Assisted Verticalization",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","* Motor control training\n* Locomotion and motor control training with elements of balance and coordination\n* Verticalization training: standing frame device and vibration platform\n* Cognitive therapy",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"* Motor control training\n* Verticalization training with Standard Frame Devices\n* Locomotion and motor control training with elements of balance and coordination\n* Cognitive therapy",[15],[28],{"name":29,"affiliation":5,"role":30},"Marek Jóźwiak","PRINCIPAL_INVESTIGATOR",[32,37],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","696052475","+48","sma@orsk.pl",{"name":38,"role":33,"phone":34,"phoneExt":11,"email":36},"Radosław Rutkowski",[40],{"facility":5,"status":41,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Poznan","61-545","Poland","PL",{"type":47,"coordinates":48},"Point",[49,50],16.92993,52.40692,{"lat":50,"lon":49},[53,54],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},{"name":38,"role":33,"phone":34,"phoneExt":11,"email":36},{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100540885","a-head-to-head-study-comparing-the-functional-value-of-two-models-of-robotically-assisted-rehabilitation-in-sma-spinal-muscular-atrophy-patients-100540885",false,"NCT06322654","A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients","A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA Patients: Single-center, Randomized, Single-blinded, Comparative Study of a Robotically Active Verticalization Model Versus Robotically Assisted Locomotion Model","SMArt","Inclusion Criteria:\n\n* Signing of informed consent to participate in the experiment by the participant or the participant's parent\u002Flegal guardian\n* Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic\n* Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth)\n* Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility.\n\nExclusion Criteria:\n\n* Cardio-respiratory disorders requiring invasive ventilation\n* Advanced osteoporosis with multiple fractures prior to treatment\n* Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM\n* Lack of cooperation with the therapist\n* Other functional indications preventing exercise","ALL","21 Years",{"count":68,"type":69},200,"ESTIMATED","INTERVENTIONAL",[72],"NA","A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.\n\nThe objective of research:\n\nThe main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.\n\n1. Research period: 4 years\n2. Patients age: 0-21 y.o.\n3. Group size: 200 patients (100 patients in each group)\n4. Assignment of patients to study groups in a randomised manner",[75],"SMA",[75,77,9,15],"Robotically-assisted therapy","2024-03-13",{"date":80,"type":81},"2024-03-21","ACTUAL",{"date":83,"type":81},"2023-12-21",{"date":85,"type":69},"2027-07",{"name":5,"class":6},1]