RT Journal Article T1 Shall we start? Ready, set, go! Toward early intervention in infants with unilateral cerebral palsy. A randomized clinical trial protocol A1 Palomo-Carrion, Rocio A1 Pinero-Pinto, Elena A1 Romay-Barrero, Helena A1 Escobio-Prieto, Isabel A1 Lillo-Navarro, Carmen A1 Romero-Galisteo, Rita-Pilar K1 early goal-directed therapy K1 early intervention K1 home environment K1 infantile hemiplegia K1 physical therapy modalities K1 upper extremity K1 Assisting hand assessment K1 Baby-cimt K1 Children K1 Reliability AB Background:It is crucial to start an early intervention in unilateral cerebral palsy. Intensive therapies are focused on training based on activities. Objective:The objective of the study was to study the changes in the bimanual functional performance (BFP) after early intensive therapies at home compared with standard care in children with unilateral cerebral palsy from 9 to 18 months of age. Design:A single-blind comparative effectiveness study will be conducted. Methods and Analysis:Children will be randomized into four groups: infant-mCIMT, infant-BIT, infant-hybrid, and infant standard therapy (control group, CG). Each early intensive protocol will last 50 h and will be applied throughout a 10-week period with the family involvement at home. The main outcomes are BFP measure with mini-Assisting Hand Assessment (mini-AHA) scale, functional goals measure with Goal Attainment Scale (GAS), and satisfaction and expectations on intensive therapy from parents measure through specific questionnaire. Baseline characteristics between groups will be compared using independent t test and Fisher's exact test. Pre- and post-treatment outcomes of standard assessments will be compared using analysis of variance (ANOVA) for parametric and Kruskal-Wallis test for non-parametric variables. The Bonferroni correction is applied for multiple comparisons. An alpha level of p PB Sage publications ltd SN 2040-6223 YR 2022 FD 2022-01-01 LK http://hdl.handle.net/10668/20234 UL http://hdl.handle.net/10668/20234 LA en DS RISalud RD Feb 16, 2025