Date

2023-06-01

Protocol

Protocol changed

Item Changed

Secondary outcome(s)

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.GMFM (Gross Motor Function Measure ): a standard assessment to evaluate the motor skills in children with cerebral palsy 2.Canadian Occupation performance Measure – parent perception of performance of the child HINE (Hammersmith Infant Neurological Examination): a neurological assessment including motor postures and reflexes in infants more than 3 months will only be used a s a covariate rather than an outcome measure 3.Feasibility measures Feasibility of the recruitment will be measured using number of infants recruited over the time period, number retained and number of confirmed eligible participants who declined enrollment. The reasons for declining will also be collected. Acceptability of randomization will be measured as number of infants lost to follow up and parents view of the randomization procedure. A guided interview will be conducted after the endpoint assessment to gather this information. Intervention adherence and intervention fidelity will be assessed using the client’s diary cards and fidelity of the intervention will be assess using the PI administered fidelity checklists. Guided interview Qualitative interviews will be used to gain information about the parent’s perspective of the feasibility of the intervention. Interviews will be held at the multidisciplinary intervention center. A topic guide will be used to guide the interview. All the interviews will be video recorded with the permission of the participants. Qualitative data from the interviews with parents will be transcribed and coded into thematic framework using NVIVO software. [baseline measurements will be taken at 3-6 months and after 6 months of intervention 9-12 months of age. Guided interview will b ecarried out after the end point assessment completed]