[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562911":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":65,"collaborators":20,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":20,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Device Arm","EXPERIMENTAL","Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training",[13],"Device: Digital therapeutic motion-based device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Digital therapeutic motion-based device","This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Katie Propst, MD","CONTACT","813-259-0655","katiepropst@usf.edu",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Maha Al Jumaily, MBBS","813-259-8680","mahaaljumaily@usf.edu",[32,49],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Tampa","Florida","33606","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-82.45843,27.94752,{"lat":43,"lon":42},[46,47],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":48,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":40,"coordinates":55},[56,57],-82.99879,39.96118,{"lat":57,"lon":56},[60,64],{"name":61,"role":24,"phone":62,"phoneExt":20,"email":63},"Lisa Hickman, MD","614-293-4643","PEARLstudy@osumc.edu",{"name":61,"role":48,"phone":20,"phoneExt":20,"email":20},{"type":66,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100562911","postpartum-pelvic-assisted-recovery-with-leva-100562911",false,"NCT06609317","Postpartum pElvic Assisted Recovery With Leva","Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population","PEARL","Inclusion Criteria:\n\n* Spontaneous vaginal delivery within the last 4-8 weeks\n* Age ≥ 18 years\n* Ambulatory\n* Willing and able to consent to participate.\n* English speaking\n* Owns a smartphone\n\nExclusion Criteria:\n\n* Operative or cesarean delivery\n* Obstetric delivery at less than 20 weeks gestation\n* Third- or fourth-degree perineal laceration\n* Episiotomy\n* Multiples","FEMALE","18 Years",{"count":78,"type":79},25,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device.\n\nIn addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum.\n\nParticipants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.",[85],"Postpartum Pelvic Floor Function and Symptoms",[87,88,89,90,91,92],"postpartum pelvic muscle training","postpartum pelvic floor","postpartum pelvic floor physical therapy","postpartum urinary incontinence","postpartum bowel incontinence","postpartum pelvic floor recovery","2025-07-24",{"date":95,"type":96},"2025-07-29","ACTUAL",{"date":98,"type":96},"2025-04-04",{"date":100,"type":79},"2026-02",{"name":5,"class":6},2]