[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429667":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":52,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":52,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":52,"overallStatus":57,"whyStopped":52,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard ACL Rehabilitation","ACTIVE_COMPARATOR","Patients will complete a 20-week supervised, progressive rehabilitation protocol directed by physical therapists at 1 of 3 participating clinics. While the specific rehabilitation exercises and techniques used for a given patient may vary depending on clinician preference\u002Fexperience and patient responsiveness and progress, the general rehabilitation protocol will be standardized and follow current best practices emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control consistent with the Multicenter Orthopaedics Outcomes Network (MOON) rehabilitation protocol.",[13],"Other: Standard ACL Rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Whole Body Vibration","EXPERIMENTAL","Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to whole body vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.",[19],"Device: Experimental: Whole Body Vibration",{"label":21,"type":16,"description":22,"interventionNames":23},"Local Muscle Vibration","Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to local muscle vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.",[24],"Device: Experimental: Local Muscle Vibration",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Experimental: Whole Body Vibration","Whole body vibration will be delivered using a commercially available device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.",[15],[32],"Power Plate pro5 (71-P5R-3100)",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Experimental: Local Muscle Vibration","Local muscle vibration will be delivered using a prototype device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.",[21],[38],"Prototype device developed by PI",{"type":6,"name":9,"description":40,"armGroupLabels":41,"otherNames":42},"Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.",[9],[43],"Usual care",[45],{"name":46,"affiliation":5,"role":47},"Troy Blackburn, PhD","PRINCIPAL_INVESTIGATOR",[49],{"name":46,"role":50,"phone":51,"phoneExt":52,"email":53},"CONTACT","919-843-2021",null,"troyb@email.unc.edu",[55,73],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"MOTION Science Institute","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-79.05584,35.9132,{"lat":67,"lon":66},[70,71],{"name":46,"role":50,"phone":52,"phoneExt":52,"email":53},{"name":72,"role":47,"phone":52,"phoneExt":52,"email":52},"Blackburn",{"facility":74,"status":75,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Womack Army Medical Center","NOT_YET_RECRUITING",{"type":64,"coordinates":77},[66,67],{"lat":67,"lon":66},[80],{"name":81,"role":50,"phone":82,"phoneExt":52,"email":53},"TROY BLACKBURN","9198432021",{"type":84,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[86],{"name":74,"class":87},"FED","100429667","vibration-and-post-traumatic-osteoarthritis-risk-following-acl-injury-100429667",false,"NCT04875052","Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury","The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury","Inclusion Criteria:\n\n* Age 16 to 35 years\n* Unilateral, primary ACLR with bone-patellar tendon-bone autograft\n\nExclusion Criteria:\n\n* History of prior ACL injury or revision ACLR\n* History of prior knee surgery\n* Requirement of multiple ligament surgery at time of ACLR\n* Concomitant injuries or surgical procedures at the time of ACLR that would delay early post-operative weight bearing based on surgeon recommendations (e.g. lower extremity fracture, intra-articular fracture, microfracture procedure)\n* Removal of more than 1\u002F3 of the medial or lateral meniscus at the time of ACLR\n* Articular cartilage damage greater than 3A on the International Cartilage Repair Society Criteria at the time of ACLR\n* History of musculoskeletal injury to either leg in the 3 months prior to participation other than primary ACL injury\n* Prior diagnosis of radiographic OA in any joint of the lower extremity\n* History of neurological disorder (e.g. stroke, multiple sclerosis, etc.)\n* Contraindications for MRI (e.g. extreme claustrophobia, cardiac pacemaker, cochlear implant, metal foreign bodies, aneurism clip, etc.)\n* Pregnant or planning to become pregnant","ALL","16 Years","35 Years",{"count":99,"type":100},114,"ESTIMATED","INTERVENTIONAL",[103],"NA","The goal of this randomized clinical trial is to evaluate the effects of vibration on factors related to the risks of post-traumatic knee osteoarthritis and secondary anterior cruciate ligament (ACL) injury in individuals who have undergone anterior cruciate ligament reconstruction surgery (ACLR). The main objectives are to compare the effects of Standard rehabilitation vs. rehabilitation that includes whole body vibration (WBV) or local muscle vibration (LMV) on:\n\n* Quadriceps muscle function\n* Gait biomechanics linked to post-traumatic knee osteoarthritis development\n* Patient self-report outcomes\n* MRI indicators of knee joint health and muscle quality\n* Landing biomechanics linked to secondary ACL injury risk\n* Evidence-based return-to-physical-activity criteria\n\nParticipants will be assigned to 1 of 3 groups (standard rehabilitation, standard rehabilitation + WBV, or standard rehabilitation + LMV) and will complete assessments of quadriceps function, gait biomechanics, landing biomechanics, functional ability, patient-report outcomes, and MRI 1, 6, and 12 months after ACLR. Researchers will compare the groups to see if vibration embedded in ACLR rehabilitation improves joint health outcomes.",[106,107,108,109],"Osteoarthritis, Knee","Anterior Cruciate Ligament Injuries","Post-traumatic Osteoarthritis","Quadriceps Muscle Atrophy","2025-05-27",{"date":112,"type":113},"2025-05-31","ACTUAL",{"date":115,"type":113},"2021-01-11",{"date":117,"type":100},"2026-08",{"name":5,"class":6},2]