[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685561":3,"trial-entities:NCT07685561":98,"trial-summary:NCT07685561":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":65,"locations":69,"central_contacts":90,"overall_officials":94,"references":96,"see_also_links":97},"NCT07685561","IRB-300016352","Restoration of Knee Extension After ACL Reconstruction","Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching","NOT_YET_RECRUITING","2032-03","2026-06","2026-07-06","2026-08","University of Alabama at Birmingham","OTHER",null,"The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee Extensionater) to standard postoperative physical therapy improves recovery of full knee extension following ACL reconstruction compared with standard physical therapy alone.",[18,19],"Knee","ACL",[19,18,21,22],"knee reconstruction","Ermi Knee Extensionator","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"PHASE1",{"count":28,"type":29},58,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Standard Physical Therapy","Routine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting.",[36,37],"Participants Receiving Standard of Care","Patient Receiving Ermi Knee Extensionator + Standard of Care",{"type":39,"name":40,"description":41,"armGroupLabels":42},"DEVICE","Ermi Knee Extensionater","Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching.\n\nThe Ermi device will be distributed to all participants in Arm 2 preoperatively. Stretching protocols will be provided at this time. Following surgery, participants must complete daily home stretching sessions (60 total minutes of end-range stretching per day) starting at postoperative day one. Each stretching session is broken down into 10 minutes of stretching, followed by 10 minutes of rest. This is repeated throughout the day until a total of 60 minutes of stretching is completed. There should be at least one hour between sessions. Stretching sessions will continue until 3 months postop.",[37],[44],{"measure":45,"description":46,"timeFrame":47},"Changes in Knee Range of Motion","A goniometer will be used to measure the post operative knee's range of motion an angle or to rotate an object to a precise angular position.","Baseline, 2 weeks, 6 weeks, and 3 months",[],"ALL","14 Years","65 Years",false,{"inclusion":54,"exclusion":58,"raw_text":64},[55,56,57],"Age 14-65 yo","Primary ACLR (BTB auto ONLY)","Prior ACL tear treated non-op",[59,60,61,62,63],"Revision ACL surgery","Major concomitant ligament reconstruction","Neurologic lower-extremity disorder","Inability to complete rehab","Cognitive impairment preventing consent","Inclusion Criteria:\n\n* Age 14-65 yo\n* Primary ACLR (BTB auto ONLY)\n* Prior ACL tear treated non-op\n\nExclusion Criteria:\n\n* Revision ACL surgery\n* Major concomitant ligament reconstruction\n* Neurologic lower-extremity disorder\n* Inability to complete rehab\n* Cognitive impairment preventing consent",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70],{"facility":13,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":87},"Birmingham","Alabama","35243","United States",[76,81,85],{"name":77,"role":78,"phone":79,"email":80},"Amit Momaya, MD","CONTACT","(205) 930-8494","amomaya@uabmc.edu",{"name":82,"role":78,"phone":83,"email":84},"Camille Crane","(303) 652 - 7821,","camillecrane@uabmc.edu",{"name":77,"role":86},"PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},33.52066,-86.80249,[91,92],{"name":77,"role":78,"phone":79,"email":80},{"name":82,"role":78,"phone":93,"email":84},"303-652-7821",[95],{"name":77,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This interventional study aims to enroll 58 participants. It compares two groups: one receiving standard physical therapy and another receiving standard physical therapy plus a home device.","completed","ACL Reconstruction Recovery Study with Ermi Knee Extensionater","This study is looking at ways to help people recover full knee movement after ACL (anterior cruciate ligament) surgery. It compares standard physical therapy to physical therapy combined with a device called the Ermi Knee Extensionater, which helps with stretching at home. You might be able to join if you are 14-65 years old and are having your first ACL reconstruction using a specific type of graft. The main goal is to see if adding the Ermi Knee Extensionater helps improve your knee's range of motion (how far it can bend and straighten) at 2 weeks, 6 weeks, and 3 months after surgery. The study is currently unclear on its recruitment status and plans to enroll 58 participants.","Participants will be followed for at least 3 months, with measurements taken at 2 weeks, 6 weeks, and 3 months after surgery.",118,"Participants will receive standard physical therapy. Those in the device group will also use the Ermi Knee Extensionater daily at home, with stretching protocols provided preoperatively. Knee range of motion will be measured at baseline, 2 weeks, 6 weeks, and 3 months.","Not stated in the trial record.",[33,40],"v2"]