[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600722":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":51,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":20,"enrollmentInfo":101,"targetDuration":20,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":116,"whyStopped":20,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"one arm","EXPERIMENTAL","SOCIAL COGNITION- VIRTUAL REALITY",[13],"Device: VIRTUAL REALITY",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","VIRTUAL REALITY","The interventional part of the study is limited to 3 centers. It explores SOCIAL COGNITION throught a newly developed paradigm in Virtual Reality.\n\nIn detail: an adapted version of the Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) using a VR Head Mounted Display (HMD) will be implemented on a portable HMD, the Oculus Quest, equipped with two controllers with motion sensors that are used to track hand position.\n\nIn a VR-SPIRIT session, participants are immersed in the playground scenario and engaged in a competition with four avatars. Each avatar has a pre-established probability to move toward one of the three described games.\n\nDifferent indices about a partecipant's performance are recorded automatically by the system during the session, such as the duration of each trial and the prediction score (percentage of trials in which the participant correctly predicted an avatar's intention).",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Maria Grazia N D'Angelo, MD PhD","CONTACT","+39 031877870","grazia.dangelo@lanostrafamiglia.it",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Maria Nobile, MD","+39 031 877111","maria.nobile@lanostrafamiglia.it",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Unit of Rare Disease- Rehabilitation Dept","Bosisio Parini","Lecco","23842","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],9.29,45.80075,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":26},"Maria Grazia D'Angelo","031877870",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52,54,56,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89],{"name":53,"class":6},"University of Padova",{"name":55,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation",{"name":57,"class":58},"Istituto Giannina Gaslini - IRCCS","UNKNOWN",{"name":60,"class":6},"Fondazione Serena Onlus - Centro Clinico NeMO Milano",{"name":62,"class":58},"Centro Clinico NeMO Ancona",{"name":64,"class":6},"IRCCS Fondazione Stella Maris",{"name":66,"class":58},"Università degli Studi di Milano Statale",{"name":68,"class":58},"Centro Clinico NeMO Brescia",{"name":70,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"name":72,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"name":74,"class":58},"I.R.C.C.S. Eugenio Medea - Associazione La Nostra Famiglia - Sede di Conegliano",{"name":76,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":78,"class":58},"Dipartimento di Neuroscienze Rita Levi Montalcini Torino",{"name":80,"class":6},"Università Vita-Salute San Raffaele",{"name":82,"class":58},"Università di Pisa",{"name":84,"class":6},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"",{"name":86,"class":58},"Associazione La Nostra Famiglia Eugenio Medea - Brindisi",{"name":88,"class":58},"Scientific Institute, IRCCS E.Medea, Pasian di Prato",{"name":90,"class":6},"IRCCS Istituto delle Scienze Neurologiche di Bologna","100600722","transition-to-adulthood-in-people-with-muscular-dystrophy-100600722",false,"NCT07101185","Transition to Adulthood in People With Muscular Dystrophy","Transition to Adulthood in People With Dystrophy: Social Cognition Mechanisms, Psychosocial Adjustment, and Mental Health and Coping Strategies.","TAMDY","Inclusion Criteria:\n\n* Defined diagnosis of DMD\n* Age \\> 14 years\n* Willingness and ability to comply to study procedures\n* Comprehension of the study and Signature of the informed consent\n\nExclusion Criteria:\n\n* Clinical history of cerebral palsy, severe intellectual deficit, severe behavioral disturbances\n* absence of compliance to the studyof the patient and the caregivers.","MALE","14 Years",{"count":102,"type":103},250,"ESTIMATED","INTERVENTIONAL",[106],"NA","The study will involve boys with Duchenne Muscular Dystrophy (DMD), from adolescence to adulthood living in Italy, and their families\u002F caregivers.\n\nThe Investigators want to explore patients' mental health, social cognition and perception of body image as well as patients'and caregivers' ability to adapt to changes related to both the disease and various personal and social needs, through the use of short and simple questionnaires, neuropsychological tests and neurocognitive evaluation in ecological scenarios using Virtual Reality. The desire for autonomy and the awareness of both personal and social difficulties in achieving them put a strain on both patients and their families.Some studies conducted in the USA and in various European countries underline that the transition to adulthood of patients with muscular dystrophy is featured by a good ability to adapt to the more advanced stages of the disease in general; nevertheless, facing the worsening of health entails experiences of anxiety and depression.In this historical phase, clinical trials of gene therapy and gene modulating therapies are involving an increasing number of patients, mainly represented by children in the early phase of the disease. Hence, adolescents and young adults could develop feelings of exclusion from research efforts, losing confidence and hope in any future improvement of their condition, social participation and quality of life.This study could lead to identify strengths and weaknesses in social cognition and psychosocial adaptation; through the evaluation of characteristics of patients\u002Fcaregivers or exogenous factors influencing higher levels of social adaptation, we ultimately aim to define strategies to improve not only physical (already defined by guidelines) but also psychological care, social cognition and social support in all stages of DMD, particularly in later ones.",[109],"Duchenne \u002F Becker Muscular Dystrophy",[111,112,113,114,115],"Duchenne muscular dystrophy","transition to adulthood,","social cognition","psychosocial adjustment","mental health and coping strategies","NOT_YET_RECRUITING","2025-08-01",{"date":119,"type":120},"2025-08-03","ACTUAL",{"date":122,"type":103},"2025-09",{"date":124,"type":103},"2027-08",{"name":5,"class":6},1]