[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625468":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":21,"responsibleParty":37,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"University of Oxford","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Participant with DMD or Healthy Control",null,"Cohort observation study of two groups undergoing the same procedures.",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Fiona Moultrie","CONTACT","+44 (0)1865 618799","fiona.moultrie@paediatrics.ox.ac.uk",{"name":19,"role":15,"phone":16,"phoneExt":10,"email":20},"Laurent Servais","laurent.servais@paediatrics.ox.ac.uk",[22],{"facility":23,"status":24,"city":25,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Oxford University","RECRUITING","Oxford","United Kingdom","UK",{"type":29,"coordinates":30},"Point",[31,32],-1.25596,51.75222,{"lat":32,"lon":31},[35],{"name":36,"role":15,"phone":16,"phoneExt":10,"email":17},"Fiona Moultrie, Dr",{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100625468","a-remote-study-using-technology-to-assess-outcomes-in-dmd-100625468",false,"NCT07423026","A Remote Study Using Technology to Assess Outcomes in DMD","TODDLER Study: Transforming Outcomes in Duchenne Muscular Dystrophy Using DigitaL Endpoints Remotely","TODDLER","Inclusion Criteria:\n\nParticipant with DMD:\n\n* Male\n* Aged 1-3 years old\n* Ambulant (walking 10m independently)\n* Genetically confirmed diagnosis of DMD\n* Parent(s)\u002Flegal guardian(s) able and willing to provide written informed consent for the child to participate in the study\n* Parent(s)\u002Flegal guardian(s) able and willing to participate in the study\n\nParent\u002Flegal guardian of participant with DMD:\n\n* Aged 18 years or more\n* Legal carer of the patient diagnosed with DMD\n* Willingness to follow study procedures and assist with remote assessments, as assessed by the research team\n* Willingness to sign the consent form\n* Ability to understand all the information with regards to the study, as assessed by the research team\n\nHealthy Control participant:\n\n* Male\n* Aged 1-3 years old\n* Ambulant (walking 10m independently)\n* Parent(s)\u002Flegal guardian\n\nExclusion Criteria:\n\nParticipant with DMD:\n\n* Limb surgery\u002Ftrauma (within 6 months)\n* Significant comorbid chronic or acute conditions affecting motor function (within 3 weeks)\n* Prematurity (born \\\u003C37 weeks' gestation)\n* Oral corticosteroids to treat DMD (before enrolment)\n* Enrolment in therapeutic clinical trials\n* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement)\n\nHealthy Control participant:\n\n* Limb surgery\u002Ftrauma (within 6 months)\n* Significant comorbid chronic condition affecting motor function\n* Significant acute condition affecting motor function (within 3weeks of enrolment)\n* Prematurity (born \\\u003C37 weeks' gestation)\n* Neurodevelopmental concerns or delay in acquisition of WHO developmental milestones.\n* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement).",true,"MALE","1 Year","3 Years",{"count":52,"type":53},60,"ESTIMATED","OBSERVATIONAL","Every year, 100 boys are born in the UK with a rare muscle disease called Duchenne muscular dystrophy. These boys cannot make an important muscle protein called dystrophin. They become weaker as they get older and lose the ability to walk as teenagers. This is a life-limiting condition. There is no cure, but medicines are being made that could help these boys make dystrophin. These medicines are most likely to work best in toddlers, before their muscles become damaged.\n\nThere is no way of testing these medicines in children under four. In older children, it is possible to measure how well and how quickly a child can do movements like sitting up, standing up, and running. Unfortunately, these tests are not suitable for toddlers as they often struggle to listen and do what they are asked to do. Tiredness and mood can also affect their scores. Luckily, there is a new way of testing how well children move. They can wear special watch-like devices on their ankles that record information about their steps as they go about their normal lives. This is a good way of testing how well a child walks. It is now used to test medicines in children over four years old. Our aim is to test whether this device works well in children under four.\n\nThis study will invite 30 boys with DMD (and their parent\u002Fcaregiver) and 30 boys without DMD aged 1-3 years old from across the country to join the study. There are no hospital visits. Children will receive the watch-like devices to wear for three blocks of 28-days over six months during their normal daily activities. At the start and end of the study, a physiotherapist will visit the homes of boys with DMD. They will check their movements using other tests. The investigators will find out 1) if young boys are happy to wear the device, 2) how it compares to other tests, and 3) if it can detect changes in walking ability.\n\nThis study could give us a way to test medicines in younger children. Wearable devices could cut down the travel and stress of tests for boys and their families. Children with learning or behavioural difficulties, and children living far from research centres could now also take part in studies of new medicines. This study could bring us a step closer to treating this life-limiting disease.",[57],"Duchenne Muscular Dystrophy (DMD)",[59,60,61],"DMD","Devices","children","2026-06-09",{"date":64,"type":65},"2026-06-10","ACTUAL",{"date":67,"type":53},"2026-06-24",{"date":69,"type":53},"2028-07-01",{"name":5,"class":6},1]