[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526049":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":43,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":81,"collaborators":26,"id":83,"slug":26,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":26,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change of lumbar pain","Improvement of Short Form 36 score (SF-36) Unit : number of points Each item is graded on a scale of 0 to 100, with 0 and 100 serving as the lowest and highest possible scores. A higher number indicates that the subject is in better overall health.","At 6 weeks and 3 months after surgery",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Improvement of functional abilities","Improvement of Oswestry Disability Index (ODI) Unit : number of points The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).",{"measure":18,"description":19,"timeFrame":12},"Improvement of ranges of motion - Ely test","Improvement of Ely test Angular unit : degree ( ° )",{"measure":21,"description":22,"timeFrame":12},"Improvement of ranges of motion - Straight Leg Test","Improvement of Straight Leg Test Angular unit : degree ( ° )",{"measure":24,"description":25,"timeFrame":12},"Improvement of ranges of motion - Schober test","Improvement of Schober test angular unit : degree ( ° )",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.\n\nThe design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).\n\nThe primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.\n\nPatients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.",[35,38],{"label":36,"type":37,"description":26,"interventionNames":26},"Standard of care","NO_INTERVENTION",{"label":39,"type":40,"description":26,"interventionNames":41},"Self rehabilitation at home","EXPERIMENTAL",[42],"Other: Self rehabilitation at home",[44],{"type":6,"name":39,"description":45,"armGroupLabels":46,"otherNames":26},"6 week program of exercise at home of gradual intensity and duration",[39],[48],{"name":49,"affiliation":5,"role":50},"Marc Khalifé, MD","PRINCIPAL_INVESTIGATOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Breno MELO, PhD","CONTACT","(0)140271988","33","gestion-locale.drc@aphp.fr",{"name":59,"role":54,"phone":26,"phoneExt":26,"email":60},"Youcef Sekour","youcef.sekour@aphp.fr",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"AP-HP - Hôpital Européen Georges-Pompidou Paris, France","RECRUITING","Paris","Île-de-France Region","75908","France","FR",{"type":71,"coordinates":72},"Point",[73,74],2.3488,48.85341,{"lat":74,"lon":73},[77,79],{"name":49,"role":54,"phone":26,"phoneExt":26,"email":78},"marc.khalife@aphp.fr",{"name":80,"role":54,"phone":26,"phoneExt":26,"email":26},"Anaïs Venard, MD",{"type":82,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100526049",false,"NCT06129682","Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)","Self-rehabilitation At Home After LumbaR Arthrodesis","SAHARA","Inclusion Criteria:\n\n* Lumbar pain and\u002For nerve root pain and\u002For limp without any motor deficiency of the limbs, before and\u002For after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)\n* Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)\n* Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and\u002For nerve root pain and\u002For limp\n* Return home possible after surgery\n* After signing consent during pre-operative visit with the surgeon\n\nExclusion Criteria:\n\n* People under 18 years-old\n* Pregnant or breast-feeding women\n* Psychiatric and\u002For neurodegenerative comorbidity\n* Motor deficiency of the limbs before and\u002For after surgery\n* Iliac extension of arthrodesis\n* Any postoperative complication lengthening stay at hospital\n* Medical contraindication for early rehabilitation","ALL","18 Years",{"count":93,"type":94},120,"ESTIMATED","INTERVENTIONAL",[97],"NA","Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.\n\nThe investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).",[100],"Spondylolisthesis, Lumbar Region","2025-03-14",{"date":103,"type":104},"2025-03-19","ACTUAL",{"date":106,"type":104},"2023-12-18",{"date":108,"type":94},"2028-10",{"name":5,"class":6},1]