[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580605":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":92,"collaborators":94,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":10,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":10,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Columbia University","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Spinal Muscular Atrophy",null,"Ambulatory children and adults at least 5 years old by the time of enrollment with genetically confirmed SMA.",{"label":13,"type":10,"description":14,"interventionNames":10},"Duchenne Muscular Dystrophy","Ambulatory children and adults ages at least 5 years old by the time of enrollment with genetically confirmed Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD\u002FBMD.",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy Control","The healthy control group will be ambulatory children and adults at least 5 years of age, age- and gender-matched to the SMA and DMD groups as best as possible.",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Jacqueline Montes, PT, EdD","CONTACT","212-305-8916","jm598@cumc.columbia.edu",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Cara Kanner, DPT","516-581-8150","chy2112@cumc.columbia.edu",[29,57,79],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Stanford University","RECRUITING","Palo Alto","California","94304","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-122.14302,37.44188,{"lat":41,"lon":40},[44,48,52,55],{"name":45,"role":21,"phone":46,"phoneExt":10,"email":47},"Sally Dunaway Young, PT, DPT","650-497-0075","sdy@stanford.edu",{"name":49,"role":21,"phone":50,"phoneExt":10,"email":51},"Constance De Monts, PT, DPT","6502502292","cdemonts@stanford.edu",{"name":53,"role":54,"phone":10,"phoneExt":10,"email":10},"John W Day, MD","PRINCIPAL_INVESTIGATOR",{"name":45,"role":56,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"facility":58,"status":31,"city":59,"state":60,"zip":61,"country":35,"countryCode":36,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":38,"coordinates":63},[64,65],-71.05977,42.35843,{"lat":65,"lon":64},[68,72,76,77],{"name":69,"role":21,"phone":70,"phoneExt":10,"email":71},"Amy Pasternak, PT, DPT","617-355-7212","amy.pasternak@childrens.harvard.edu",{"name":73,"role":21,"phone":74,"phoneExt":10,"email":75},"Maria Fragala Pinkham, PT, DPT, DSc","6173557212","maria.pinkham@childrens.harvard.edu",{"name":69,"role":54,"phone":10,"phoneExt":10,"email":10},{"name":78,"role":56,"phone":10,"phoneExt":10,"email":10},"Maria F Fragala Pinkham, PT, DPT, Dsc",{"facility":80,"status":31,"city":81,"state":81,"zip":82,"country":35,"countryCode":36,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Columbia University Irving Medical Center","New York","10032",{"type":38,"coordinates":84},[85,86],-74.00597,40.71427,{"lat":86,"lon":85},[89,91],{"name":90,"role":21,"phone":22,"phoneExt":10,"email":23},"Jacqueline Montes",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},{"type":54,"investigatorFullName":90,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator",[95,97,98,101],{"name":96,"class":6},"Stevens Institute of Technology",{"name":30,"class":6},{"name":99,"class":100},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":102,"class":6},"Boston Children's Hospital, Boston, MA, USA","100580605","establishing-walking-related-digital-biomarkers-in-rare-childhood-onset-progressive-neuromuscular-disorders-100580605",false,"NCT06839469","Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders","Inclusion Criteria:\n\n* Genetic confirmation of disease (DMD, SMA) or healthy control\n* Able to walk independently at least 25 meters\n* Ongoing corticosteroids therapy or initiation of corticosteroid therapy in the previous 3 months for DMD\n* Stable dose of FDA approved SMN up-regulator therapy or in an open-label extension phase of a study treatment for at least 6 months for SMA or gene replacement at enrollment for SMA or DMD participants.\n\nExclusion Criteria:\n\n* Use foot orthoses or assistive devices for community ambulation or a mobility device for community navigation\n* Use investigational medications intended for treatment of NMD within 30 days\n* Prior to study entry had an injury or surgery that would impact gait within the previous 3 months",true,"ALL","5 Years",{"count":113,"type":114},106,"ESTIMATED","OBSERVATIONAL","The purpose of this research is (1) to identify disease specific walking-related digital biomarkers of disease severity, and (2) monitor longitudinal changes in natural environments, for extended periods of time, in DMD and SMA.",[118,119],"Spinal Muscular Atrophy Type 3","Duchenne Muscular Dystrophy (DMD)",[121,122,123,124,125,126,127,128,129,130,131,132,133],"SMA","spinal muscular atrophy","duchenne muscular dystrophy","DMD","instrumented insole","neuromuscular disease","machine learning model","gait analysis","functional biomarker","wearable","six minute walk test","ambulatory","becker phenotype","2026-04-06",{"date":136,"type":137},"2026-04-09","ACTUAL",{"date":139,"type":137},"2024-05-01",{"date":141,"type":114},"2028-04-01",{"name":5,"class":6},3]