[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100392441":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":12,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Children's Healthcare of Atlanta","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Participants in the control arm will follow the standard-of-care treatment exercises for the 6 months following ACL reconstruction surgery.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Test (BFRT)","EXPERIMENTAL","Participants in the test arm will follow the identical physical therapy exercises as the control arm but will perform the exercises with BFRT during the first 16 weeks post-surgery. After reaching the 16-week mark, participants will complete the identical standard-of-care rehabilitation between weeks 16-24.",[18],"Device: Blood Flow Restriction using Delfi Personalized Tourniquet System",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Blood Flow Restriction using Delfi Personalized Tourniquet System","Participants assigned to the test group will undergo blood flow restriction training 2 days per week beginning at week 1-2 post-surgery and continuing through week 16 post-surgery using the FDA-approved Delfi Personalized Tourniquet System (PTS) with personalized pressure of 80% of the limb occlusion pressure (LOP). The LOP is the amount of pressure required to fully occlude arterial and venous blood flow to the limb. Otherwise, both the test group and control group will follow a standard 6-month post-surgery rehabilitation protocol which is standard of care for ACLR recovery.",[14],[26],{"name":27,"affiliation":28,"role":29},"Jeanne Graf, PT, DPT, ATC","Clinical Site Supervisor, Physical Therapist","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","404-785-8421","jeannie.graf@chao.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Children's Healthcare of Atlanta Physical Therapy","RECRUITING","Atlanta","Georgia","30342-3269","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-84.38798,33.749,{"lat":48,"lon":47},[51],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":52},"jeannie.graf@choa.org",{"type":29,"investigatorFullName":54,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Jeanne Perkis","100392441","bfrt-in-adolescents-after-acl-reconstruction-100392441",false,"NCT04390035","BFRT in Adolescents After ACL Reconstruction","Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery","Inclusion Criteria:\n\n1. Adolescent male and female patients, age 12-18\n2. Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children.\n3. Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA\n4. Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.\n5. English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.\n\nExclusion Criteria:\n\n1. Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging\n2. Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)\n3. History of previous knee surgery\n4. History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)\n5. ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting\n6. Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)\n7. Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection\n8. Failure to adhere to attendance requirements as detailed below:\n\n   * Attend first PT visit (PTV) within 5 days post-surgery\n   * Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery",true,"ALL","12 Years","18 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[71],"NA","This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study aims to identify the effect of BFRT on quadriceps muscle strength and the patient's quality of life, and the overall tolerability of BFRT will be examined. Eight physical therapists at four sports medicine physical therapy (PT) sites will oversee all post-operative PT sessions. Subjects allocated to the BFR group will undergo BFRT, while control group will undergo standard-of-care ACLR rehabilitation, 2 days per week for 16 weeks. Measurements of strength, quality of life, and overall function will be completed at regular intervals.",[74],"Anterior Cruciate Ligament Rupture",[76,77,78],"Adolescents","Blood Flow Restriction Training","Patient-reported Outcomes","2021-07-27",{"date":81,"type":82},"2021-08-02","ACTUAL",{"date":84,"type":82},"2020-09-23",{"date":86,"type":68},"2023-04",{"name":5,"class":6},1]