[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424886":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":74,"collaborators":33,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":33,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":62,"whyStopped":33,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,16,20,24],{"label":9,"type":6,"description":10,"interventionNames":11},"ASD with decompensated sagittal misalignment","Adults suffering from a spinal deformity with a decompensated sagittal misalignment",[12,13,14,15],"Other: 2D versus 3D analysis of EOS stereo radiographic analysis","Other: Static versus dynamic analysis","Other: Pre- versus postoperative analysis","Other: Reliability of the dynamic evaluation",{"label":17,"type":6,"description":18,"interventionNames":19},"ASD with compensated sagittal misalignment","Adults suffering from a spinal deformity with a compensated sagittal misalignment",[12,13,14,15],{"label":21,"type":6,"description":22,"interventionNames":23},"ASD without sagittal misalignment","Adults suffering from a spinal deformity without a sagittal misalignment",[12,13,14,15],{"label":25,"type":6,"description":26,"interventionNames":27},"Control group","Asymptomatic adults not suffering from a spinal deformity",[12,13,15],[29,34,38,42],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"2D versus 3D analysis of EOS stereo radiographic analysis","The use of EOS stereo radiographic analysis and health related quality of life scores to measure the distance of the center of acoustic meati in the transversal plane with respect to the gravity line",[17,9,21,25],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Static versus dynamic analysis","The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms",[17,9,21,25],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Pre- versus postoperative analysis","The use of EOS stereo radiographic imaging and motion analysis to understand the compensation mechanisms in trunk, pelvis and lower limbs and the correlation between primary and secondary mechanisms.",[17,9,21],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Reliability of the dynamic evaluation","Repeated measurements of the different aspects of the dynamic evaluation protocol (strenght measurements of trunk muscles, balance evaluation and movement analysis) will serve to evaluate the test-retest reliability and intra-rater reliability of the different protocols",[17,9,21,25],[47],{"name":48,"affiliation":5,"role":49},"Lieven Moke","PRINCIPAL_INVESTIGATOR",[51,55],{"name":48,"role":52,"phone":53,"phoneExt":33,"email":54},"CONTACT","+32 16 34 08 84","lieven.moke@uzleuven.be",{"name":56,"role":52,"phone":57,"phoneExt":33,"email":58},"Lennart Scheys","+32 16 34 08 85","lennart.scheys@uzleuven.be",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":33},"UZ Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":69,"coordinates":70},"Point",[71,72],4.70093,50.87959,{"lat":72,"lon":71},{"type":75,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100424886","multimodal-bio-mechanical-analysis-of-adult-spinal-deformity-with-sagittal-plane-misalignment-100424886",false,"NCT04812730","Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment","ASD","Inclusion Criteria:\n\n* Pathological group\n\n  1. Age \\>= 45 years\n  2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity\n  3. Scoring at least 25 out of 30 on Mini Mental State Examination\n  4. Ability to walk at least 50 meters distance independently without a walking aid\n  5. Sagittal malalignment: PI-LL ≥ 25 degrees; sagittal vertical axis \\>5cm; pelvic tilt \\>25° and\u002For thoracic kyphosis \\> 60° and\u002For coronal malalignment: thoracic scoliosis 30 ≥ degrees; thoracolumbar\u002Flumbar scoliosis ≥ 30 degrees; global coronal malalignment \\>3cm, posterior spinal fusion \\> 4 levels + iliac fixation.\n  6. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires\n  7. Completed patient informed consent\n* Control group\n\n  1. Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium\n  2. Age \\>=45 years old\n  3. Scoring at least 27 out of 30 on Mini Mental State Examination\n  4. Ability to walk at least 1000 meters distance independently without a walking aid\n  5. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires\n  6. Completed patient informed consent\n\nExclusion Criteria:\n\n* Pathological group\n\n  1. Age \\\u003C 45 years old\n  2. Absence of adult spinal deformity\n  3. Scoring less than 25 out of 30 on Mini Mental State Examination\n  4. Non-ability to walk at least 50 meters distance independently, with or without a walking aid.\n  5. Missing patient informed consent\n  6. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and\u002For Vestibular lesion\n  7. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)\n  8. BMI\\>30\n* Control group\n\n  1. Age \\\u003C 45 years old\n  2. Backpain and\u002For Sciatica at time of the study\n  3. Presence of adult spinal deformity leading to a pathological sagittal alignment\n  4. Scoring less than 27 out of 30 on Mini Mental State Examination\n  5. Non-ability to walk at least 1000 meters distance independently without a walking aid\n  6. Missing patient informed consent\n  7. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and\u002For Vestibular lesion\n  8. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)\n  9. BMI \\> 27",true,"ALL","18 Years","79 Years",{"count":88,"type":89},265,"ESTIMATED","INTERVENTIONAL",[92],"NA","A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up.\n\nInvestigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity.\n\nThe challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.",[95],"Spinal Deformity",[97,98,99,100],"Sagittal plane misalignment","Trunk and lower limb","Motion analysis","EOS stereo radiography","2026-03-12",{"date":103,"type":104},"2026-03-13","ACTUAL",{"date":106,"type":104},"2016-01",{"date":108,"type":89},"2028-12",{"name":5,"class":6},1]