This study adapts and evaluates the Spanish version of eTIPS, an early home-based therapy program for infants at risk of unilateral cerebral palsy after perinatal stroke. The project has three parts: translation and cultural adaptation of the original materials, a pilot randomized feasibility study comparing eTIPS with usual care, and a qualitative study exploring family experiences, barriers, and facilitators to using the program at home.
In the first part, the study team will translate and culturally adapt the eTIPS materials for Spanish-speaking families, review them with experts, and test whether the content is clear, relevant, and usable. In the second part, families with infants diagnosed with perinatal stroke or at high risk of unilateral cerebral palsy will be assigned to either the eTIPS program or usual clinical care to assess recruitment, retention, adherence, safety, acceptability, and preliminary effects on infant motor development and family outcomes. In the third part, caregivers in the intervention group will take part in interviews to better understand how the program fits into daily life and what could improve future implementation.
Infants with confirmed unilateral perinatal stroke diagnosis by neuroimaging, identified within first 3 months of life
Age at recruitment ≤3 months postnatal (intervention starts when clinically stable, maximum term-equivalent age)
Written informed consent from parents/legal guardians
Known progressive neurodegenerative disorder or severe medical comorbidity preventing participation (e.g., ventilation-dependent respiratory failure)
Extensive bilateral intracerebral lesion making lateralized intervention irrelevant
Concurrent participation in another clinical trial with interfering treatment
Parallel
eTIPS
BehavioralParent-delivered, home-based early therapy for infants with perinatal stroke or risk of unilateral cerebral palsy. Families receive the Spanish-adapted eTIPS materials, training, and ongoing support to integrate lateralized therapeutic activities into daily routines from enrollment until corrected age 6 months. The intervention is delivered alongside usual clinical care
Usual Clinical Care
BehavioralStandard neonatal, neurological, and rehabilitation follow-up according to local clinical practice. Includes routine pediatric neurology monitoring, periodic neurological evaluations to track motor development and detect early signs of unilateral cerebral palsy, and referral to pediatric rehabilitation with physiotherapy sessions (1 session/week or biweekly, 30-45 minutes) focused on mobilizations, muscle tone control, joint range maintenance, general sensory stimulation, and basic postural guidelines.
Recruitment Rate
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate
Retention Rate
Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention
Adherence Rate
Days per week and minutes per week of practice recorded in digital diary/app. Success criterion: ≥70% practice days
Usability (SUS Score)
System Usability Scale (SUS) score for materials and platform. Target: ≥70 points
Safety
Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
Parental Satisfaction
Likert-scale questionnaire on experience, confidence gained, and recommendation of program
Fidelity
Professional observation of correct eTIPS technique application during scheduled visits
Hand Assessment for Infants (HAI)
Video-based observational assessment of unimanual and bimanual hand function
Infant Motor Profile (IMP)
Structured observation of fine and gross motor patterns
Paediatric Stroke Outcome Measure (PSOM)
Neurological and functional sequelae monitoring post-stroke
Bayley Scales of Infant Development (BSID-IV)
Standardized assessment of cognitive, motor and socio-emotional development in children from 1 to 42 months.
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