[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575605":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":27,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":27,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":87,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Children with neuromotor disorders","During Visit 1, children will perform both a validated 3D protocol and the instrumented 3D serious game (developed version). After each session, questionnaires will be distributed to participants to assess the added value of the immersive environment.\n\nDuring Visit 2, children will have a clinical examination (goniometry, muscle strength, spasticity, motor selectivity) and functional assessments by experienced therapists at hospital and will perform the instrumented 3D serious game.",[12],"Device: instrumented 3D serious game (BE API 3.0)",{"label":14,"type":6,"description":15,"interventionNames":16},"Typically developing children","Children will have one visit to the hospital (Visit 1). They will perform the instrumented serious game, in order to assess the discriminant validity of the upper limb movement features between children with neuromotor disorders and typically developing children.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","instrumented 3D serious game (BE API 3.0)","It is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the upper limb (UL) and trunk (3D motion analysis and electromyography), and he\u002Fshe can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing\u002Fremoving markers and the game.",[9,14],[24,25,26],"Clinical and functional tests","Validated 3D protocol (old version)","Questionnaires",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Marine Cacioppo, MD, PhD","CONTACT","+41 79 553 84 67","marine.cacioppo@hug.ch",[35],{"facility":36,"status":27,"city":37,"state":27,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Geneva University Hospital","Geneva","1205","Switzerland","CH",{"type":42,"coordinates":43},"Point",[44,45],6.14569,46.20222,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":27,"email":51},"Elodie Von Dach, PhD","+41223729827","Elodie.vonDach@hug.ch",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Marine Cacioppo","MD, PhD","100575605","validation-of-a-3d-instrumented-serious-game-to-evaluate-upper-limb-impairments-in-children-with-neuromotor-disorders-100575605",false,"NCT06774456","Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders","Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders","Play2BEAPI","Inclusion Criteria:\n\n* Children with NMD\n\n  * Informed Consent signed by the subject\n  * Aged from 5 to 13 years,\n  * Non-progressive neurological lesions (cerebral palsy, stroke, traumatic brain injury, etc.),\n  * With sufficient grasp ability to perform the 3D protocol tasks (MACS level I to III),\n* TD children\n\n  * Informed Consent signed by the subject\n  * Aged from 5 to 13 years,\n\nExclusion Criteria:\n\n* Children with neuromotor disorders\n\n  * inability to follow the procedures of the investigation because of severe cognitive or visual disturbances,\n  * upper limb (UL) disorders that may affect movement (fractures less than 6 months prior to participation, pain (visual analogic score (VAS) score \\> 0), etc.).\n  * previous UL surgery, and botulinum toxin injections less than three months prior to participation,\n* TD children\n\n  * Inability to follow the procedures of the investigation because of severe visual disturbances,\n  * UL disorders that may affect movement (fractures less than 6 months prior to participation, pain (VAS score \\> 0), etc.).",true,"ALL","5 Years","13 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are:\n\n* Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ?\n* Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a \"classic\" 3D protocol, thanks to the developped environment ?\n\nResearchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement.\n\nChildren with neuromotor disorders will have 2 visits to the hospital :\n\n* Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game\n* Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game\n\nTypically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.",[76,77,78],"Cerebral Palsy","Brain Injury","Neurological; Disorder, Nervous System",[80,81,82,83,84,85,86],"Children","upper limb","motion analysis","serious game","neuromotor disorders","bimanual function","electromyography","NOT_YET_RECRUITING","2025-01-08",{"date":90,"type":91},"2025-01-14","ACTUAL",{"date":93,"type":70},"2025-02",{"date":95,"type":70},"2027-01",{"name":5,"class":6},1]