[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459949":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":51,"responsibleParty":73,"collaborators":75,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":10,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL)",null,"patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UH Leuven",[13,14,15],"Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL","Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL","Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL",{"label":17,"type":10,"description":18,"interventionNames":19},"healthy controls","age, BMI and gender matched to the patients with LLL",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"subgroup (n=40)","a subgroup of subjects (patients \\& healthy controls) will be evaluated again 2 weeks later",[13,14,15,24],"Diagnostic Test: Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLL",[26,31,35,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DIAGNOSTIC_TEST","Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL","pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy\u002Fanalysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist and a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL) that is completed by the patient at the end of this evaluation",[17,9,21],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Assessor B: measurement methods and questionnaires for the assessment of LLL","pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy\u002Fanalysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist",[17,9,21],{"type":27,"name":36,"description":33,"armGroupLabels":37,"otherNames":10},"Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL",[17,9,21],{"type":27,"name":39,"description":29,"armGroupLabels":40,"otherNames":10},"Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLL",[21],[42],{"name":43,"affiliation":44,"role":45},"Tessa De Vrieze, Dr.","KU Leuven","PRINCIPAL_INVESTIGATOR",[47],{"name":43,"role":48,"phone":49,"phoneExt":10,"email":50},"CONTACT","003216345006","tessa.devrieze@kuleuven.be",[52],{"facility":53,"status":54,"city":55,"state":10,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University Hospitals of Leuven, center for lymphedema","RECRUITING","Leuven","3000","Belgium","BE",{"type":60,"coordinates":61},"Point",[62,63],4.70093,50.87959,{"lat":63,"lon":62},[66,70],{"name":67,"role":48,"phone":68,"phoneExt":10,"email":69},"Nele Devoogdt, PhD","0032 16 342515","nele.devoogdt@uzleuven.be",{"name":71,"role":48,"phone":72,"phoneExt":10,"email":50},"Tessa De Vrieze, PhD","0032 16 34 50 06",{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[76],{"name":44,"class":6},"100459949","development-of-a-clinical-screening-diagnostic-and-evaluation-tool-for-patients-with-lower-limb-lymphedema-aim-1-100459949",false,"NCT05269264","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL","EvaLymph-Leg1","Inclusion Criteria:\n\nPatient group\n\n* Unilateral or bilateral, primary or secondary Lower limb lymphedema (LLL)\n* Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor\u002F 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow\n* Age ≥ 18 years\n* Able to read, understand and speak Dutch\n\nHealthy controls\n\n\\- Age, gender \\& BMI-matched healthy controls\n\nExclusion Criteria:\n\n* Pregnant participants\n* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome\n* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion",true,"ALL","18 Years",{"count":89,"type":90},200,"ESTIMATED","OBSERVATIONAL","Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL).\n\nThe objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.",[94],"Lower Limb Lymphedema",[96,97,98,99,100,101,102],"Lymphedema","Measurement","Clinical evaluation","Reliability","Concurrent validity","Clinical feasibility","Lower limb","2024-07-01",{"date":105,"type":106},"2024-07-03","ACTUAL",{"date":108,"type":106},"2022-02-07",{"date":110,"type":90},"2025-10",{"name":5,"class":6},1]