[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374016":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"blood flow restriction therapy (pressure cuff)","EXPERIMENTAL","The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.",[13],"Behavioral: Physical Therapy with pressure cuff",{"label":15,"type":16,"description":17,"interventionNames":18},"blood flow restriction therapy (placebo)","PLACEBO_COMPARATOR","Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm",[19],"Behavioral: Physical Therapy with placebo pressure cuff",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Physical Therapy with pressure cuff","6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Physical Therapy with placebo pressure cuff","6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.",[15],[32],{"name":33,"affiliation":34,"role":35},"Guillem Gonzales-Lomas, MD","NYU Langone","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Samy Shelbaya","CONTACT","517-575-5522","Samy.shelbaya@nyulangone.org",[43],{"facility":5,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","New York","10016","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-74.00597,40.71427,{"lat":53,"lon":52},[56,60],{"name":57,"role":39,"phone":58,"phoneExt":26,"email":59},"Dhruv Shankar","240-848-8645","dhruv.shankar@nyulangone.org",{"name":61,"role":35,"phone":26,"phoneExt":26,"email":26},"Guillem Gonzalez-Lomas, MD",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100374016","blood-flow-restriction-therapy-in-lower-limb-extensor-injuries-100374016",false,"NCT04149977","Blood Flow Restriction Therapy in Lower Limb Extensor Injuries","Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study","Inclusion Criteria:\n\n* Must be at least 18 years of age and younger than 65 years of age\n* ASA class I-II\n* Diagnosed with a lower limb extensor injury (quadriceps tendon rupture, patella tendon rupture, patella fracture)\n* Intention to receive physical therapy as standard of care\n\nExclusion Criteria:\n\n* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)\n* Younger than 18 years of age or older than 65\n* Any patient considered a vulnerable subject\n* Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension\n* Concomitant lower extremity traumatic injuries, delaying or precluding the subject's ability to participate in the therapy\n* Immobile or use of mobile assistive device prior to injury\n* No prior extensor injuries\n* Patients with Sickle cell anemia or venous thromboembolism\n* Patients with cancer or Lymphectomies\n* Patients with increased intracranial pressure\n* Patients with intention to receive standard therapy and not the study therapy",true,"ALL","18 Years","65 Years",{"count":76,"type":77},128,"ESTIMATED","INTERVENTIONAL",[80],"NA","The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.",[83],"Lower Limb Injury","2025-09-24",{"date":86,"type":87},"2025-09-26","ACTUAL",{"date":89,"type":87},"2021-09-01",{"date":91,"type":77},"2026-06-01",{"name":5,"class":6},1]