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Trials - SLCTR/2021/016

Protocol Change

Date

2026-02-25


Protocol

Protocol changed


Item Changed

Secondary outcome


Previous Version

1.GMFM (Gross Motor Function Measure ): a standard assessment to evaluate the motor skills in children with cerebral palsy HINE (Hammersmith Infant Neurological Examination): a neurological assessment including motor postures and reflexes in infants more than 3 months. [baseline measurements will be taken at 3-6 months and after 6 months of intervention 9-12 months of age.]; 2.Canadian Occupation performance Measure - parent perception of performance of the child [baseline measurements will be taken at 3-6 months and after 6 months of intervention, i.e 9-12 months of age.].


Next Version

1. Bayley Scale of Infant and Toddler Development version III - cognitive subtest; 2. Gross Motor Function Measure (GMFM-88): a standard assessment to evaluate the motor skills in children with cerebral palsy; 3. Canadian Occupation performance Measure: parent perception of performance of the child Covariates: Hammersmith Infant Neurological Examination (HINE), a neurological assessment including motor postures and reflexes in infants more than 3 months will be used as a covariate rather than an outcome measure; 4. Feasibility measures: Feasibility and acceptability of the CCITSN were assessed using quantitative and qualitative indicators. Quantitative feasibility outcomes included the number and proportion of children recruited and retained, as well as the number of confirmed eligible participants who declined enrolment; reasons for declining participation were documented. Intervention adherence of fidelity was evaluated using parent-completed diary cards and fidelity checklists administered by the principal investigator. In addition, qualitative semi-structured interviews were conducted with mothers of participating children to explore their perceptions of the acceptability, feasibility, and perceived usefulness of the intervention.