[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595599":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Instituto Teletón Chile","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","Children Aged 8-17 With Spastic Hemiparetic Cerebral Palsy Treated With Botulinum Toxin Type A",[13],"Procedure: Botulinum toxin infiltration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Botulinum toxin infiltration","Botulinum toxin is a medication that is injected directly into the muscles selected by a physiatrist, based on a clinical evaluation. The doses are determined according to the clinical condition of the spasticity, the patient's age, and weight. The procedure is performed under deep sedation and uses ultrasound and electrostimulation to ensure greater safety and precision.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Israel A Patino","CONTACT","+56967045412","israel.patino@teleton.cl",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Manuel J Duran","+56952577100","manuel.duran@teleton.cl",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Instituto Teleton Santiago","RECRUITING","Santiago","Santiago Metropolitan","9160000","Chile","CL",{"type":41,"coordinates":42},"Point",[43,44],-70.64827,-33.45694,{"lat":44,"lon":43},[47,48],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":49,"role":24,"phone":50,"phoneExt":20,"email":51},"Diego Rocha","+56998177183","diego.rocha@teleton.cl",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100595599","effect-of-botulinum-toxin-type-a-on-motor-function-in-children-with-cerebral-palsy-100595599",false,"NCT07034547","Effect of Botulinum Toxin Type A on Motor Function in Children With Cerebral Palsy","Effect of Botulinum Toxin Type A on Functionality and Quality of Life in Children and Adolescents With Spastic Hemiparetic Cerebral Palsy GMFCS I-II at Teletón Santiago: A Prospective Single-Group Trial","Inclusion Criteria:\n\n* Spastic hemiparesis type Cerebral Palsy\n* Gross Motor Classification System I-II\n* Age 8 to 17 years (based on validation ages for scales to be used)\n* Minimum of 6 months since last botulinum toxin injection\n* Informed consent signed by legal guardian and assent from users aged 12 to 17 years\n\nExclusion Criteria:\n\n* Cognitive impairment that prevents following instructions for functional assessments\n* Limitation of joint range not caused by spasticity\n* Patients diagnosed with other diseases causing spasticity, different from cerebral palsy\n* Patients with other neuromuscular diseases","ALL","8 Years","17 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"NA","Project Identification and Researchers Title: \"Changes in functionality and quality of life when applying the botulinum toxin type A infiltration protocol in children and adolescents with cerebral palsy of the spastic hemiparesis type GMFCS I and II, from the Teletón Institute Santiago: A prospective single-group trial.\"\n\nThis project is led by a group of physiatrists from the Teletón Institute, along with a team of co-investigators specialized in kinesiology, occupational therapy, and nursing.\n\nStudy Relevance The study aims to generate scientific evidence on the effectiveness of the BoNT-A infiltration protocol in the functionality and quality of life of children with spastic hemiparesis. The results could optimize therapeutic interventions at the Teletón Institute, improve patient well-being, and expand the coverage of therapeutic services for spasticity.\n\nProblem Statement Cerebral palsy (CP) is the most common motor disability in childhood, with an estimated prevalence of 1.6 per 1,000 live births in developed countries and between 1 and 2 per 1,000 live births in Chile. Spastic CP requires multidisciplinary management, including BoNT-A infiltration. Although BoNT-A has been shown to reduce spasticity, there is a gap in knowledge regarding its impact on overall functionality and quality of life.\n\nResearch Question What changes occur in functionality and quality of life when applying the BoNT-A infiltration protocol from the Teletón Institute Santiago in children aged 8 to 17 years, diagnosed with cerebral palsy of the spastic hemiparesis type GMFCS I and II?\n\nStudy Objectives General Objective: To compare the results in functionality and quality of life before BoNT-A infiltration, at 4 weeks, and at 12 weeks, in children and adolescents diagnosed with cerebral palsy of the spastic hemiparesis type GMFCS I and II.\n\nSpecific Objectives: To evaluate the effect of the infiltration protocol on the functionality of the upper and lower limbs, and on the quality of life of the children and their families.\n\nHypothesis The BoNT-A infiltration protocol has a positive effect on the functionality of the upper and lower limbs and on the quality of life of children with spastic cerebral palsy.\n\nMethod The study is a prospective single-group trial, following participants over time to compare the results of the BoNT-A infiltration protocol. The target population includes children with spastic hemiparesis cerebral palsy GMFCS I-II referred to the botulinum toxin infiltration clinic at the Teletón Institute Santiago. A non-probabilistic convenience sampling will be used, selecting individuals who meet the inclusion and exclusion criteria.\n\nProcedure Patients will be selected and evaluated before infiltration, at 4 weeks, and at 12 weeks post-infiltration. The infiltration will be performed under ultrasound and electrostimulation guidance. Evaluations will include functionality and quality of life scales, such as the Ashworth Scale, Tardieu Scale, Bilan 400 Points Functional Hand Scale, GMFM-88, KIDSCREEN-27, and Goal Attainment Scale.\n\nData Collection Data collection will be carried out through clinical record review, clinical observation, and application of scales. A homologation protocol will be implemented among operators to standardize the use of the scales.\n\nVariables Variables include age, sex, laterality, GMFCS, infiltrated muscles, infiltration dose, educational level, participation in a school integration program, physical activity, manual functionality, lower limb functionality, quality of life, and goal attainment.\n\nStatistical Analysis A database will be created in Microsoft Excel, and qualitative and quantitative variables will be analyzed. Chi-square tests, repeated measures ANOVA, and Friedman tests will be used to compare measurements over time.\n\nEthical Considerations The study complies with ethical principles of scientific validity, social utility, researcher competence, favorable risk-benefit ratio, equitable selection of subjects, informed consent, and protection of the privacy and confidentiality of participants.",[72,73,74],"Cerebral Palsy (CP)","Spasticity Due to Cerebral Palsy","Hemiparesis",[76,77,78],"botulinum toxin","quality of life","Physical Functional Performances","2025-12-09",{"date":81,"type":82},"2025-12-17","ACTUAL",{"date":84,"type":82},"2025-06-11",{"date":86,"type":66},"2026-05-30",{"name":5,"class":6},1]