[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580060":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":39,"overallOfficials":29,"centralContacts":29,"locations":45,"responsibleParty":93,"collaborators":29,"id":95,"slug":29,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":29,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":29,"studyType":107,"phases":29,"briefSummary":108,"conditions":109,"keywords":29,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Gross Motor Function Measure (GMFM)","The GMFM is composed by 88 items (providing a range of score form 0 to 3 each) divided in 5 sections: A- lying and rolling; B- sitting; (C) crawling and kneeling; D - standing; E - walking, running and jumping.\n\nThe total score can range between 0 (subject can't perform any gross motor activity) to a maximum of 264 (the subject completely developed his gross motor skills).","A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Six minutes walking test (6MWT)","The test is used to evaluate the walking endurance. During the test the distance covered over six minute of self-paced walking along a standardized path is measured, providing a reliable measure of patient's limitations as community ambulators.",{"measure":18,"description":19,"timeFrame":12},"Scale for the Assessment and Rating of Ataxia (SARA)","This scale is developed to quantify the severity of the ataxia. It includes motor tasks (that investigate the most common deficits, like imbalance, tremors, dysmetria, rhythmic movements) and one item that examine the speech. This validated tool scores from 0 (no ataxia) to 40 (severe ataxia) and is composed by 8 items that comprise assessment of speech, upper and lower limb ability",{"measure":21,"description":22,"timeFrame":12},"Pediatric Balance Scale (PBS)","The scale is used to assess balance skills in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.",{"measure":24,"description":25,"timeFrame":12},"WeeFIM","This assessment measures the type and amount of assistance required for a person with a disability to perform basic life activities effectively.\n\nIt is an 18-item performance measurement system that documents self-care, functional mobility, and cognitive abilities. The self-care domain includes 8 items (eating, grooming, bathing, lower and upper body dressing, toileting, as well as bowel and bladder control). The mobility domain includes 5 items (chair, toilet, and tub transfers, walking or wheelchair management, and stairs). The cognitive domain includes 5 items (language comprehension and expression, social interaction, problem solving, and memory).",{"measure":27,"description":28,"timeFrame":12},"gait analysis","3D gait analysis is an assessment performed with an eight cameras optoelectronic system working at 100 Hz and two force plates. During the analysis participants are asked to walk at their preferred speed and barefoot. For each assessment, at least five trials for the left and the right limbs were collected and processed using dedicated software. The most representative trial for each child is selected for further analysis.",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":6,"maskingInfo":29},"COHORT","The surgery aimed to remove tumors located in the cranial posterior fossa can lead, as a consequence, to a clinical condition of ataxia.\n\nChildren affected by this condition are commonly referred to physiotherapy treatment, even though the level of scientific evidence in the field of motor rehabilitation is still lacking.\n\nThe objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors.\n\nBy conventional physiotherapy intervention we mean a therapeutic path with a 1:1 operator-patient ratio and which does not make use of robotic or virtual reality devices.\n\nBy intensive we mean that it occurs twice a day, 5 days a week, for a duration of four weeks.\n\nGiven the high variability in the severity of the clinical pictures, the primary objective will be the patient's improvement in gross motor skills as a whole, which will be identified with the Gross Motor Function Measurment (GMFM) scale.\n\nChanges will also be monitored with respect to the autonomy and assistive care in the daily life of the recruited patients (scored through WeeFIM or FIM), the risk of fall (scored through the Pediatric Balance Scale) and with a sign-specific scale on ataxia (Scale for Assessment and Rating of Ataxia) Finally, for walking patients, walking resistance will be assessed through the 6 minute walking test (6MWT)","Children, teen agers and young adults affected by posterior fossa tumors will be collected in three different centers, nemely IRCCS Medea located in Bosisio Parini, Conegliano and Brindisi.",[35],{"label":36,"type":29,"description":29,"interventionNames":37},"study group",[38],"Procedure: intensive physiotherapy",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":29},"PROCEDURE","intensive physiotherapy","the dosing of the intensive physiotherapy is of 2 sessions a day, lasting 45 minutes each, administered 5 days a week, for a period of 4 weeks.\n\nthe physiotherapy is mainly addressed to the improvement of gross motor movement and balance and the training is designed according to the specific need of the subject recruited. it is not allowed the use of technological devices, excepted treadmill training.",[36],[46,65,79],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"IRCCS E. Medea","RECRUITING","Brindisi","72100","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],17.93607,40.63215,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":63,"phoneExt":29,"email":64},"Claudia Zigrino, Physiotherapy degree","CONTACT","0831 349431","claudia.zigrino@lanostrafamiglia.it",{"facility":47,"status":48,"city":66,"state":67,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Bosisio Parini","Lecco","23842",{"type":54,"coordinates":70},[71,72],9.29,45.80075,{"lat":72,"lon":71},[75],{"name":76,"role":62,"phone":77,"phoneExt":29,"email":78},"Daniele Panzeri, Physiotherapy degree","+39 031 877878","daniele.panzeri@lanostrafamiglia.it",{"facility":47,"status":48,"city":80,"state":81,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Conegliano","Treviso","31015",{"type":54,"coordinates":84},[85,86],12.30201,45.88805,{"lat":86,"lon":85},[89],{"name":90,"role":62,"phone":91,"phoneExt":29,"email":92},"Silvia Spolverato, neuropsychiatry degree","0438410257","silvia.spolverato@lanostrafamiglia.it",{"type":94,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100580060",false,"NCT06832384","Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors","Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa","Inclusion Criteria:\n\n* subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years\n\nExclusion Criteria:\n\n* Subjects that are currently addressed to rehabilitative protocols availing of technological devices","ALL","0 Years","25 Years",{"count":105,"type":106},40,"ESTIMATED","OBSERVATIONAL","The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors",[110],"Posterior Fossa Tumor","2025-02-12",{"date":113,"type":114},"2025-02-18","ACTUAL",{"date":116,"type":114},"2023-01-19",{"date":118,"type":106},"2026-01-19",{"name":5,"class":6},3]