protocolSection identificationModule nctId: NCT06288971, orgStudyIdInfo id: IRCCS FSM, briefTitle: Personalized Innovative Intervention Pathways to Promote EF in Children With CP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: University of Pisa, collaborators name: University of Florence, collaborators name: Anastasis Società Cooperativa Sociale, descriptionModule briefSummary: Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and/or visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3)., conditionsModule conditions: Executive Functions in Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, interventions name: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills, interventions name: Game-based tools for the rehabilitation of EF and motor planning, outcomesModule primaryOutcomes measure: changes in score of inhibition subtest at the NEPSY-II, secondaryOutcomes measure: changes in score of the sustained attention subtest at the Leiter-3, secondaryOutcomes measure: changes in score of Developmental Test of Visual-Motor Integration (VMI), secondaryOutcomes measure: changes in score of MOXO-continuous performance test, secondaryOutcomes measure: changes in score of Corsi block-tapping subtest at the BVS-corsi, secondaryOutcomes measure: changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents, secondaryOutcomes measure: changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test., secondaryOutcomes measure: changes in score of reading and text comprehension task at the ALCE, secondaryOutcomes measure: changes in score of reading and writing task at the DDE-2, secondaryOutcomes measure: changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18, secondaryOutcomes measure: changes in score of Go/No-Go and N-back 1 subtest at the teleFE, secondaryOutcomes measure: changes in score of verbal fluency subtest at the NEPSY-II, secondaryOutcomes measure: changes in score of Test of Visual Perception and Visuo-motor Integration (TPV), secondaryOutcomes measure: changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2), secondaryOutcomes measure: changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2), secondaryOutcomes measure: changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, city: Pisa, zip: 56128, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False