[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580605":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":91,"collaborators":93,"id":102,"slug":10,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":10,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":10,"enrollmentInfo":110,"targetDuration":10,"studyType":113,"phases":10,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"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",[29,56,78],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Stanford University","RECRUITING","Palo Alto","California","94304","United States",{"type":37,"coordinates":38},"Point",[39,40],-122.14302,37.44188,{"lat":40,"lon":39},[43,47,51,54],{"name":44,"role":21,"phone":45,"phoneExt":10,"email":46},"Sally Dunaway Young, PT, DPT","650-497-0075","sdy@stanford.edu",{"name":48,"role":21,"phone":49,"phoneExt":10,"email":50},"Constance De Monts, PT, DPT","6502502292","cdemonts@stanford.edu",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"John W Day, MD","PRINCIPAL_INVESTIGATOR",{"name":44,"role":55,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"facility":57,"status":31,"city":58,"state":59,"zip":60,"country":35,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":37,"coordinates":62},[63,64],-71.05977,42.35843,{"lat":64,"lon":63},[67,71,75,76],{"name":68,"role":21,"phone":69,"phoneExt":10,"email":70},"Amy Pasternak, PT, DPT","617-355-7212","amy.pasternak@childrens.harvard.edu",{"name":72,"role":21,"phone":73,"phoneExt":10,"email":74},"Maria Fragala Pinkham, PT, DPT, DSc","6173557212","maria.pinkham@childrens.harvard.edu",{"name":68,"role":53,"phone":10,"phoneExt":10,"email":10},{"name":77,"role":55,"phone":10,"phoneExt":10,"email":10},"Maria F Fragala Pinkham, PT, DPT, Dsc",{"facility":79,"status":31,"city":80,"state":80,"zip":81,"country":35,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Columbia University Irving Medical Center","New York","10032",{"type":37,"coordinates":83},[84,85],-74.00597,40.71427,{"lat":85,"lon":84},[88,90],{"name":89,"role":21,"phone":22,"phoneExt":10,"email":23},"Jacqueline Montes",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},{"type":53,"investigatorFullName":89,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator",[94,96,97,100],{"name":95,"class":6},"Stevens Institute of Technology",{"name":30,"class":6},{"name":98,"class":99},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":101,"class":6},"Boston Children's Hospital, Boston, MA, USA","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":111,"type":112},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.",[116,117],"Spinal Muscular Atrophy Type 3","Duchenne Muscular Dystrophy (DMD)",[119,120,121,122,123,124,125,126,127,128,129,130,131],"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":134,"type":135},"2026-04-09","ACTUAL",{"date":137,"type":135},"2024-05-01",{"date":139,"type":112},"2028-04-01",{"name":5,"class":6},3]