[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528166":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":45,"collaborators":47,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":25},{"fullName":5,"class":6},"Spaarne Gasthuis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multifactorial Approach Training (MAT)","EXPERIMENTAL","MAT involves an evidence-based core outcome-set of interventions aimed at both regaining functional stability of the shoulder and also diminishing fear of (recurrent) dislocation and kinesiophobia. The protocol is based on a recent international Delphi-based consensus study, initiated since no protocol yet existed focusing on this psychological component of traumatic anterior shoulder instability.",[13],"Other: MAT",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR)","ACTIVE_COMPARATOR","The original guidelines which most physiotherapists use throughout the rehabilitation of their patients following ABR is the ASSET guideline \\[2\\].",[19],"Other: CABRR",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"MAT","The protocol consists of four phases: 1) immobilization phase, 2) early protective phase, 3) intermediate phase and 4) late phase. The detailed guideline can be found in the following article:\n\nGaunt, B. W., Shaffer, M. A., Sauers, E. L., Michener, L. A., McCluskey, G. M., \\& Thigpen, C. A. (2010). The American Society of Shoulder and Elbow Therapists' Consensus Rehabilitation Guideline for Arthroscopic Anterior Capsulolabral Repair of the Shoulder. Journal of Orthopaedic \\& Sports Physical Therapy, 40(3), 155-168. https:\u002F\u002Fdoi.org\u002F10.2519\u002Fjospt.2010.3186",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"CABRR","The protocol consists of four phases: 1) immobilization phase, 2) early phase, 3) intermediate phase and 4) advanced phase.\n\nThe protocol comprises education, modified cognitive behavioral therapy, neuromuscular control exercises, kinetic chain exercises, range of motion enhancing exercises, strength and conditioning exercises, and sport-specific exercises. The protocol is currently unpublished.",[15],[31],{"name":32,"affiliation":33,"role":34},"Arthur van Noort, MD PhD","Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Madu N Soares, BSc.","CONTACT","+31648164073","msoaresfilho@spaarnegasthuis.nl",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Theodore P van Iersel, MD","+31614564784","vanierselted@gmail.com",{"type":46,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[48,51,53,55,57],{"name":49,"class":50},"OLVG","NETWORK",{"name":52,"class":6},"Ziekenhuis Amstelland",{"name":54,"class":6},"Gelre Hospitals",{"name":56,"class":6},"Medisch Spectrum Twente",{"name":58,"class":6},"Flevoziekenhuis","100528166","multifactorial-approach-training-for-anterior-shoulder-instability-in-patients-undergoing-arthroscopic-bankart-repair-100528166",false,"NCT06157229","Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair","Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial","MATASI","Inclusion Criteria:\n\n* Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)\n* Aged between 18-67 years\n* Planned arthroscopic Bankart repair (ABR) surgery\n* Understanding of spoken and written Dutch language\n* Written informed consent (according to the ICH-GCP guidelines)\n* Positive apprehension sign at physical examination\n\nExclusion Criteria:\n\n* Posterior or multidirectional shoulder instability\n* Presence of hyperlaxity of the upper extremity and absence of sulcus sign and \\>85 degrees of external rotation with the arm at the side at physical examination\n* Connective tissue disorders (e.g. Ehlers-Danlos)\n* Aged \\\u003C18 or \\>67 years\n* Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)\n* History of soft tissue repair or bone block procedure on one of both shoulders\n* Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)\n* Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)\n* Neurological disorders or systemic disease\n* Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder\n* Hill-Sachs lesion visible on external rotation radiographs\n* Greater tubercle fracture","ALL","18 Years","67 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation, following the American Society of Shoulder and Elbow Therapists guideline and patients that underwent 'multifactorial approach training', which focusses on decreasing kinesiophobia and fear of recurrent dislocations.\n\nThe study population comprises patients who will undergo Arthroscopic Bankart Repair (ABR) after a traumatic anterior shoulder dislocation at Spaarne Gasthuis Haarlem\u002FHoofddorp, OLVG Amsterdam, Amstelland Ziekenhuis Amstelveen, Gelre Ziekenhuizen, Medisch Spectrum Twente, or Flevoziekenhuis Almere.",[78,79,80,81],"Shoulder Instability","Shoulder Dislocation or Subluxation","Fear of Movement","Kinesiophobia","NOT_YET_RECRUITING","2023-11-27",{"date":85,"type":86},"2023-12-05","ACTUAL",{"date":88,"type":72},"2024-01-01",{"date":90,"type":72},"2027-06-01",{"name":5,"class":6}]