[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondation Ildys\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":228},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,85,119,148,175,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640399","pharmacokinetics-of-antibiotics-in-patients-with-cystic-fibrosis-trated-with-elexacaftortezacaftorivacaftor-eti-100640399",false,"NCT07629986","Pharmacokinetics of Antibiotics in Patients With Cystic Fibrosis Trated With Elexacaftor\u002FTezacaftor\u002FIvacaftor (ETI)","PKCF","Inclusion Criteria:\n\n* Diagnosis of cystic fibrosis confirmed by sweat test and\u002For genetic testing\n* Treatment with elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) for at least 3 months\n* Age 12 years or older\n* Patient informed and not objecting to participation; for minors, parents\u002Flegal guardians informed and not objecting to participation\n* Clinical indication for antibiotic therapy for pulmonary exacerbation or respiratory infection according to treating physician\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Lung transplantation or heart-lung transplantation\n* Patients under guardianship or curatorship\n* Pregnant or breastfeeding women","ALL","12 Years",{"count":19,"type":20},30,"ESTIMATED","OBSERVATIONAL","Cystic fibrosis (CF) is associated with major pharmacokinetic and pharmacodynamic alterations affecting antibiotic exposure, including changes in absorption, distribution, metabolism, and elimination. Historically, these alterations justified the use of higher antibiotic doses in CF patients in order to achieve therapeutic concentrations and improve pulmonary outcomes.\n\nThe advent of highly effective CFTR modulators, particularly the triple combination elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI), has substantially improved pulmonary function, nutritional status, inflammatory burden, and quality of life in patients with CF. ETI therapy also appears to modify respiratory microbiology and reduce the frequency of pulmonary exacerbations.\n\nThese clinical and physiological improvements may alter antibiotic pharmacokinetics and pharmacodynamics in patients with CF, potentially making current high-dose antibiotic recommendations less appropriate for some patients. Since repeated exposure to high-dose antibiotics is associated with cumulative toxicities, particularly aminoglycoside-related ototoxicity and nephrotoxicity, reassessment of antibiotic dosing strategies is warranted.\n\nThe PKCF study is a multicenter, prospective, observational, non-interventional study designed to characterize the pharmacokinetic profiles of intravenous antibiotics administered during pulmonary exacerbations in adolescents and adults with cystic fibrosis receiving ETI therapy.",[24,25,26],"Cystic Fibrosis (CF)","Pulmonary Exacerbation","Respiratory Infection Bacterial",[28,29,30,31,32,33,25],"Cystic Fibrosis","CFTR modulators","Elexacaftor\u002FTezacaftor\u002FIvacaftor","Antibiotics","Pharmacokinetics","Therapeutic drug monitoring","RECRUITING","2026-06-01",{"date":37,"type":38},"2026-06-05","ACTUAL",{"date":40,"type":38},"2026-03-19",{"date":42,"type":20},"2028-05",{"name":44,"class":45},"Fondation Ildys","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":46},"100590110","association-of-a-habit-ile-course-and-a-home-programme-on-the-bimanual-performance-of-children-with-cerebral-palsy-100590110","NCT06963151","Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy","Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children Aged 3 to 5 Years With Cerebral Palsy: a Multicentre Randomised Controlled Trial of Non-inferiority","PARTNERSHIP","Inclusion Criteria:\n\n1. Child with unilateral CP confirmed by a physician\n2. Child aged between 3 years and 5 years 11 months (corrected age) at study entry\n3. Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.\n4. Ability to understand instructions and complete all assessments.\n5. Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.\n6. Written informed consent obtained from a parent or legal guardian.\n7. Commitment to having the same parent or guardian participate throughout the study.\n\nExclusion Criteria:\n\n1. Diagnosis of ataxic CP.\n2. Uncontrolled epilepsy.\n3. History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).\n4. Visual or auditory deficits that could interfere with participation in the study.\n5. Significant cognitive or behavioural disorder limiting the ability to follow instructions, as reported in discussions with the family, therapists and\u002For during a prior assessment","3 Years","5 Years",{"count":58,"type":20},66,"INTERVENTIONAL",[61],"NA","This non-inferiority, mixed-methods, multicentre randomised controlled trial will compare the effects of functional changes and families' resources at 3 months of the PARTNER programme (35h HABIT-ILE + 15h home programme) with the reference HABIT-ILE programme (50h) on the bimanual performance (Assisting Hand Assessment \\[AHA\\]) of 66 children with unilateral CP aged 3 to 5 years.",[64],"Cerebral Palsy",[66,67,68,69,70,71,72,73,74,75,64],"HABIT-ILE","Intensive motor therapy","Motor skill learning","Parental Coaching","Children","Additional Relavant MeSH Terms","Nervous System Diseases","Brain Damage, Chronic","Brain Diseases","Central Nervous System Diseases","NOT_YET_RECRUITING","2026-04-14",{"date":79,"type":38},"2026-04-15",{"date":81,"type":20},"2027-01-01",{"date":83,"type":20},"2029-09-01",{"name":44,"class":45},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},"100617090","impact-evaluation-of-breizh-fabribus-intervention-for-personalized-assistive-technology-creation-or-adaptation-100617090","NCT07314099","Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation","Évaluation d'Impact de l'Intervention du Breizh Fabribus Pour la création ou l'Adaptation d'Aide Technique personnalisée (BFB-IMPACT)","BFB-IMPACT","Inclusion Criteria:\n\n* Any person who has received assistance from BFB for the creation or adaptation of assistive technology\n\nExclusion Criteria:\n\n* objection to the use of their data\n* Sollicitation but no delivery of technical assistance by BFB",true,{"count":95,"type":20},70,"In France, more than 14 million individuals report severe functional limitations, and nearly 5 million struggle with essential daily activities. Traditional barriers to assistive technology-high costs, lengthy funding delays, lack of information, and poorly fitting off-the-shelf solutions-frequently lead to underuse, dissatisfaction, and environmental waste The BFB-IMPACT study evaluates the real-world effectiveness of Breizh Fabribus, a mobile workshop equipped with 3D printing and laser-cutting that produces and customizes assistive devices on site for people with disabilities in Finistère, France region. This retrospective, single-center investigation includes all service recipients from January 2024 to December 2025 and measures changes in users' ability to perform targeted activities at three months post-intervention. Secondary outcomes include user satisfaction and device utilization. Data collection occurs from October 2025 to May 2026, with analysis anticipated in June 2026 and results published in the second half of 2026.",[98,99,100,101,102],"Amputation","Functional Limitation","Autonomy of Older People","Handicaps Physical","Autonomy",[104,105,106,107,108,109,110],"mobile workshop","3D printing","laser cutting","personalized devices","user satisfaction","functionnal autonomy","disability","2025-12-17",{"date":113,"type":38},"2026-01-02",{"date":115,"type":20},"2025-12",{"date":117,"type":20},"2026-11",{"name":44,"class":45},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":59,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100596074","effects-of-the-use-of-an-immersive-virtual-reality-device-on-handwriting-in-children-aged-6-to-13-with-handwriting-difficulties--rvaligo--100596074","NCT07040722","Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties ( RVALIGO )","Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties : a Randomized Multiple Baseline Single-case Experimental Design (SCED)","RVALIGO","Inclusion Criteria:\n\n* Age : 6-13 years\n* BHK: degradation score ≥ 1 standard deviation. The BHK will be administered at the time of the inclusion visit (V1) and\u002For child with writing difficulties in in daily activities.\n* Children benefiting or to benefit from rehabilitation care to improve handwriting skills.\n* Be able to understand instructions and complete all assessments.\n\nExclusion Criteria:\n\n* Contraindications to using a virtual reality HMD\n* Severe visual impairment\n* Facial injury\n* Epilepsy\n* Lack of parental and\u002For child consent","6 Years","13 Years",{"count":130,"type":20},12,[61],"Difficulties in learning to write affect a large number of children and can have a significant impact on their personal and professional future. To facilitate this learning process, develop fun, motivating and effective devices for the different skills involved in writing (motor skills, postural control, visual attention, letter recognition) is needing. Virtual Reality (VR) seems to be a promising tool for this purpose.\n\nThe SCED (Single Case Experimental Design) methodology is adapted to this study to evaluate the impact of VR on learning to write, as it allows a high level of evidence and is applicable to a heterogeneous population such as that affected by difficulties in learning to write. The study will include an original study of 3 children and 3 replications of 3 children each. In total, 12 children will be included in four different settings. This study will determine whether VR training can facilitate learning to write.\n\nThe main objective of this study is to evaluate the impact of immersive virtual reality training on handwriting using the Evaligo tool to assess static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting difficulties according to a SCED methodology.",[134],"Children With a Need of Rehabilitation for Handwriting",[136,137,138,70,139],"Handwriting difficulties","Virtual reality","SCED","Pediatric rehabilitation",{"date":141,"type":38},"2025-12-24",{"date":143,"type":38},"2025-10-01",{"date":145,"type":20},"2027-09-01",{"name":44,"class":45},5,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":59,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":46},"100582073","impact-of-the-kaligo-solution-on-learning-to-write-in-children-aged-6-to-11-with-handwriting-disorders--kaligo-100582073","NCT06858566","Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders : KALIGO+","Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders: a Multiple Baseline Online SCED Study","KALIGO+","Inclusion Criteria:\n\n* Children with writing difficulties (who may or may not be receiving care in this area)\n* Age: 6 - 11 years\n* Score \\> 1 standard deviation on the BHK deterioration score\n\nExclusion Criteria:\n\n* Contraindication to the use of the tablet or virtual reality\n* Moderate, severe or profound intellectual disability (Total Intelligence Quotient below 55 on an intellectual efficiency scale such as WISC-V or K-ABC-II).","11 Years",{"count":158,"type":20},15,[61],"Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Initial studies into the use of new technologies (tablets, virtual reality headsets) have shown that they can help children learn to write. Attractive to children, these interfaces make it possible to apply new paradigms (e.g. enrichment of feedback \\[sonification\\], variation of writing media) that have proved effective, mainly with children with 'typical' development. The Kaligo+ solution is based on the latest scientific advances to offer an innovative approach to learning to write, particularly for children with significant difficulties in this area. This study proposes to test the benefits of the Kaligo+ solution on 15 children with writing difficulties.\n\nThe main objective of this pilot study is to demonstrate improved writing performance following use of the Kaligo+ solution in children aged 6 to 11 with writing difficulties, using a Single Case Experimental Design (SCED) methodology.",[162],"Writing Disorder",[164,165,166,70],"learning to write","writing disorders","SCED study","2025-03-27",{"date":169,"type":38},"2025-03-28",{"date":171,"type":38},"2025-03-21",{"date":173,"type":20},"2027-02-24",{"name":44,"class":45},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":93,"sex":16,"minAge":127,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100564274","virtual-reality-implantation-in-paediatric-rehabilitation-implant-vr4-child-100564274","NCT06627049","Virtual Reality Implantation in Paediatric Rehabilitation (IMPLANT-VR4 CHILD)","IMPLANT-VR4","Inclusion Criteria for rehabilitation professionals::\n\n* Rehabilitation professional\n* Be fluent in French.\n* Work in the paediatric wards at Ty Yann or Perharidy.\n* Consent to data processing\n\nInclusion Criteria for Children :\n\n* Be aged between 6 and 18.\n* Be fluent in French.\n* Have received rehabilitation treatment in the Ty Yann or Perharidy paediatric services.\n* Have already used virtual reality in a rehabilitation session.\n* Have the consent of the child and his\u002Fher legal representative to take part in the study.\n\nInclusion Criteria for decision makers:\n\n* Work at the ILDYS Foundation as a health executive or within the management team.\n* Be fluent in French.\n* Consent to data processing\n\nExclusion Criteria:\n\n* Not being able to understand focus group or interview questions.\n* Not being able to communicate during focus groups or interviews.","99 Years",{"count":184,"type":20},39,"Virtual Reality Implementation in Paediatric Rehabilitation (IMPLANT-VR 4 CHILD) Virtual Reality (VR) and Active Video Games (AVG) are promising devices for children in need of rehabilitation. VR and AVG have been widely studied in research, with promising results in a number of areas, including motor function, cognitive function, pain management and attention disorders.\n\nHowever, despite these promising results and the enthusiasm they generate in research, VR and AVG are rarely used in clinical practice, particularly in the paediatric services of Ty Yann and Perharidy of the ILDYS Foundation. There is a strong demand from professionals for these tools to be better integrate these devices into their clinical practice.\n\nThe project is to conduct an action research with rehabilitation professionals, health managers and children in need of rehabilitation in order to facilitate the implementation of VR and AVG in the paediatric rehabilitation services of Ty Yann and Perharidy. Firstly, the facilitators and barriers present in these services will be identified. Then, specific strategies to facilitate the implementation of VR will be used. Finally, the impact of these strategies on the use of VR will be evaluated.",[187],"Children with Undergoing Rehabilitation",[189,190,191,192,193],"Virtual Reality","Active Video Games","Paediatric rehabilitation","Implementation Science","Action Research","2024-10-14",{"date":196,"type":38},"2024-10-16",{"date":198,"type":20},"2024-10",{"date":200,"type":20},"2025-11",{"name":44,"class":45},2,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":93,"sex":16,"minAge":211,"maxAge":182,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":202},"100552188","french-translationadaptation-of-ahemd-sr-fr-ahemd-100552188","NCT06469840","French Translation\u002FAdaptation of AHEMD-SR (FR-AHEMD)","French Translation\u002FAdaptation of Affordances in the Home Environnent for Motor Development Self-Report (AHEMD-SR)","FR-AHEMD","Parents Group :\n\nInclusion Criteria:\n\n* Parents of a child aged 18 to 42 months with a diagnosis of delayed motor development\n* Taken in charge in one of the participating centers for an intensive motor rehabilitation training\n* Francophone by birth\n\nExclusion Criteria:\n\n* Parent opposing participation in the study\n\nExperts Group :\n\nInclusion Criteria:\n\n* Professional\n* Holding a French state diploma in the field of rehabilitation\n* Participating in an intensive motor rehabilitation training in one of the participating centres.\n* Proof of experience in paediatric rehabilitation (lasting 5 years).\n* Francophone by birth\n\nNon-inclusion criteria :\n\n\\- Expert opposing participation in the study","18 Years",{"count":213,"type":20},60,"The aim of this study is to develop a French translation and adaptation of the original English version of the AHEMD-SR.",[216],"Motor Disorders",[218,219,139],"AHEMD-SR","Motor Development","2024-07-08",{"date":222,"type":38},"2024-07-09",{"date":224,"type":38},"2024-06-21",{"date":226,"type":20},"2025-01",{"name":44,"class":45},""]