protocolSection identificationModule nctId: NCT06343688, orgStudyIdInfo id: BAIBU-FTR-SAT-5, briefTitle: "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: " Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval.", conditionsModule conditions: Diplegic Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO", outcomesModule primaryOutcomes measure: Wii Balance Board, primaryOutcomes measure: "The Gross Motor Function Measure-88 (D-E) (GMFM-88), primaryOutcomes measure: The Functional Reach Test, primaryOutcomes measure: "The Pediatric Berg Balance Scale (PBBS), secondaryOutcomes measure: "The Eating and Drinking Ability Classification System (EDACS), secondaryOutcomes measure: "The Manual Abilities Classification System (MACS), secondaryOutcomes measure: "The Gross Motor Function Classification System (GMFCS), secondaryOutcomes measure: "The Communication Function Classification System (CFCS), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False