[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05754632":3,"trial-entities:NCT05754632":138,"trial-summary:NCT05754632":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":70,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":14,"eligibility_criteria":92,"std_ages":105,"locations":108,"central_contacts":125,"overall_officials":131,"references":136,"see_also_links":137},"NCT05754632","22-139","The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial","RECRUITING","2029-05-01","2026-01","2026-01-07","2023-06-08","Connecticut Children's Medical Center","OTHER",false,"While there are a number studies that have reported on the use of blood flow restriction training (BFRT) in the adult population, there is limited information about the use of BFRT in the adolescent population. This study aims to evaluate the use of BFRT in conjunction with traditional anterior ligament reconstruction (ACLR) rehabilitation in adolescents.\n\nThe purpose of this study is to compare the addition of a BFRT based exercise protocol to a standard ACL rehabilitation protocol in adolescents. Does the addition of BFRT-based exercise improve strength, hypertrophy, and patient reported outcomes after ACLR in the adolescent population?","A single randomized control trial will compare the use of exercises augmented with BFRT with quantitative measurements of strength and patient-reported outcomes. A total of 40 youth and adolescent patients undergoing a surgical procedure for ACLR and subsequent physical therapy at our institution will be recruited for this study. Patients will be randomized into one of two groups using computer randomization for allocation: the intervention group receiving BFRT as part of physical therapy, and the control group will follow the institution's standard ACLR rehabilitation protocol. Both groups will follow a time- and criterion-based standardized rehabilitation protocol. The primary outcomes will be isometric and isokinetic knee peak torque and limb symmetry indices. Secondary outcomes will be quadriceps hypertrophy via mid-thigh circumference and patient-reported outcomes.\n\nTarget Population Adolescent patients between the ages of 12 and 18 will be recruited at the time of surgery, specifically, those that participate in sports who are undergoing primary ACLR reconstruction at Connecticut Children's\n\nStudy Group and Control Group Inclusion Criteria\n\n· Prior to surgery participated in \\> 50 hours\u002Fyear of level I or II sports as defined by Noyes et al and planned to return to prior level.\n\nLevel I Sports (4-7 days\u002Fweek) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey) Level II sports (1-3 days\u002Fweek) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey)\n\n* Completion of postoperative rehabilitation following standard protocols\n* Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.",[18,19,20],"Anterior Cruciate Ligament Injuries","Knee Injuries","Quadriceps Muscle Atrophy",[22,23],"physical therapy","rehabilitation","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DEVICE","Blood Flow Restriction using Delfi Personalized Tourniquet System","The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device.",[37],"BFR Intervention Group",[39],"FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VAN",[41,45,49,52,55,58,62,64,67],{"measure":42,"description":43,"timeFrame":44},"Range of Motion","Active knee range of motion: Knee AROM will be measured in supine position using a goniometer and standardized procedures reported by Norkin and White","Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op",{"measure":46,"description":47,"timeFrame":48},"Isometric Quad strength Peak Torque","Isometric strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.","Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op",{"measure":50,"description":51,"timeFrame":48},"Isometric Quadriceps Strength limb symmetry index","Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \\[ ( peak torque quadriceps involved limb (ft\u002Flbs)\u002F peak torque quadriceps uninvolved limb (ft-lbs))\\*100\\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.",{"measure":53,"description":54,"timeFrame":48},"Isometric Hamstring Strength Peak Torque","Isometric strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.",{"measure":56,"description":57,"timeFrame":48},"Isometric Hamstring Strength Limb Symmetry Index","Hamstring limb symmetry index is calculated by taking the values from outcome 3 \\[ ( peak torque hamstring involved limb (ft\u002Flbs) \u002F peak torque hamstring uninvolved limb (ft-lbs))\\*100\\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal perfect symmetry.",{"measure":59,"description":60,"timeFrame":61},"Isokinetic Quadriceps strength","Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.","Change in strength at 6 months and 9 months post-op",{"measure":63,"description":51,"timeFrame":61},"Isokinetic Quadriceps Strength limb symmetry index",{"measure":65,"description":66,"timeFrame":61},"Isokinetic Hamstrings Strength","Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.",{"measure":68,"description":69,"timeFrame":61},"Isokinetic Hamstring Strength limb symmetry index","Hamstring limb symmetry index is calculated by taking the values from outcome 1. \\[ ( peak torque quadriceps involved limb (ft\u002Flbs)\u002F peak torque quadriceps uninvolved limb (ft-lbs))\\*100\\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.",[71,75,79,82,85],{"measure":72,"description":73,"timeFrame":74},"Quadriceps Hypertrophy","Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity","Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op",{"measure":76,"description":77,"timeFrame":78},"Pediatric International Knee Documentation Committee","Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).","Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op",{"measure":80,"description":81,"timeFrame":78},"Knee Outcomes and Osteoarthritis Scale","Patient Reported Outcome Measure- The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. This scoring direction, 100 indicating no problems",{"measure":83,"description":84,"timeFrame":78},"Anterior Cruciate Ligament- Return to Sport after Injury","Patient Reported Outcome Measure- The scores range from 0 to 100, with higher scores representing patients who are more ready to return to sport",{"measure":86,"description":87,"timeFrame":88},"Tegner Activity Scale","Tegner activity scale will measure sport level- higher level equals higher sport competitive level","changes from pre-operative, 9 months, and 2 years post-operative","ALL","12 Years","18 Years",{"inclusion":93,"exclusion":98,"raw_text":104},[94,95,96,97],"Prior to surgery participated in \\>50 hours\u002Fyear of level I or II sports as defined by Noyes et al and planned to return to prior level.","Level II sports (1-3 days\u002Fweek) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)","Completion of postoperative rehabilitation following standard protocols","Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.",[99,100,101,102,103],"An additional lower extremity injury at time of knee injury or previous surgical intervention on the knee (ipsilateral and contralateral)","Multiple ligament ruptures or trauma","Weight bearing restrictions for greater than 4 weeks after surgery due to concomitant pathology such as meniscal root\u002Fradial repair, chondral pathology, or multi-ligament pathology","Follow-up surgical procedures including, but not limited to, post-operative arthrofibrosis Inability to attend regular physical therapy sessions (≥80% of patient treatment sessions and all assessment visits","Contraindications to performing BFRT including known history of central or peripheral neurologic impairments, cardiac or metabolic condition or history of deep vein thrombosis (DVT).","Inclusion Criteria:\n\n* Prior to surgery participated in \\>50 hours\u002Fyear of level I or II sports as defined by Noyes et al and planned to return to prior level.\n\nLevel I Sports (4-7 days\u002Fweek) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)\n\n* Level II sports (1-3 days\u002Fweek) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)\n* Completion of postoperative rehabilitation following standard protocols\n* Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.\n\nExclusion Criteria:\n\n* An additional lower extremity injury at time of knee injury or previous surgical intervention on the knee (ipsilateral and contralateral)\n* Multiple ligament ruptures or trauma\n* Weight bearing restrictions for greater than 4 weeks after surgery due to concomitant pathology such as meniscal root\u002Fradial repair, chondral pathology, or multi-ligament pathology\n* Follow-up surgical procedures including, but not limited to, post-operative arthrofibrosis Inability to attend regular physical therapy sessions (≥80% of patient treatment sessions and all assessment visits\n* Contraindications to performing BFRT including known history of central or peripheral neurologic impairments, cardiac or metabolic condition or history of deep vein thrombosis (DVT).",[106,107],"CHILD","ADULT",[109],{"facility":110,"status":7,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":122},"Connecticut Children's Sports Physical Therapy","Farmington","Connecticut","06032","United States",[116],{"name":117,"role":118,"phone":119,"phoneExt":120,"email":121},"Adam P Weaver, PT, DPT","CONTACT","860-284-0246","79296","aweaver@connecticutchildrens.org",{"lat":123,"lon":124},41.71982,-72.83204,[126,128],{"name":117,"role":118,"phone":127,"phoneExt":120,"email":121},"8602840296",{"name":129,"role":118,"phone":127,"phoneExt":120,"email":130},"Arthur Fredericks, MSPT","afredericks@connecticutchildrens.org",[132],{"name":133,"affiliation":134,"role":135},"Adam Weaver, PT, DPT","Physical Therapist","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":139,"biomarkers":143},[140,141,142],"Atrophy of quadriceps femoris muscle","Injury of anterior cruciate ligament","Knee Injury",[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a randomized controlled trial, meaning participants will be randomly assigned to either receive BFRT with physical therapy or standard physical therapy. The study plans to enroll 40 adolescents.","completed","Blood Flow Restriction Training After ACL Reconstruction in Adolescents","This study is investigating if adding Blood Flow Restriction Training (BFRT) to standard physical therapy helps adolescents recover better after Anterior Cruciate Ligament (ACL) surgery. BFRT uses a special device, the Delfi Personalized Tourniquet System, during exercise to safely regulate blood flow. Researchers want to see if this combination improves strength, muscle size (hypertrophy), and how patients feel about their recovery compared to standard physical therapy alone. You might be able to join if you are 12 to 18 years old, play sports regularly (over 50 hours\u002Fyear of Level I or II sports), and are having ACL reconstruction surgery. The study will measure your knee's range of motion and strength at different times over nine months to see if the BFRT helps.","Participants will be followed for 9 months after their ACL reconstruction surgery.",122,"You would participate in physical therapy, with one group also using the Delfi Personalized Tourniquet System. Your range of motion and strength will be measured before surgery and at 3, 6, and 9 months post-surgery.","Not stated in the trial record.",[],"v2"]