Early Parent-delivered Home-based Intervention, Perinatal Stroke and Risk of Unilateral Cerebral Palsy, Spanish Cross-cultural Adaptation of eTIPS
Conditions
Keywords
eTIPS, perinatal stroke, unilateral cerebral palsy, early intervention, infant rehabilitation
Brief summary
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.
Detailed description
This is a mixed-methods study designed to translate, culturally adapt, and evaluate the Spanish version of eTIPS, an early, parent-delivered therapy program originally developed for infants with perinatal stroke and risk of unilateral cerebral palsy. The project follows a staged approach with three linked phases: Phase I, translation and cross-cultural adaptation of the intervention materials; Phase II, a pilot randomized feasibility study; and Phase III, a qualitative study of family experiences and implementation. Phase I will include forward translation, back-translation, expert review, and feedback from caregivers and professionals to ensure semantic, conceptual, and cultural equivalence of the Spanish materials. Phase II will randomize eligible infants to eTIPS or usual care, with the intervention delivered by caregivers in the home environment and supported by the research team. Outcomes in this phase will focus on feasibility and process measures such as eligibility, recruitment, consent, retention, adherence, usability, safety, and fidelity, as well as exploratory infant and caregiver outcomes. The infant assessments may include measures of hand function, motor development, neurological status, and stroke-related outcomes, while caregiver outcomes may include well-being, stress, competence, and bonding. Phase III will use semi-structured interviews and thematic analysis to explore how caregivers experience the intervention in everyday routines, including perceived benefits, barriers, facilitators, and suggestions for improvement. The results will be used to refine the Spanish eTIPS program and inform the design of a future definitive multicenter trial.
Interventions
BEHAVIORALeTIPS
Parent-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
BEHAVIORALUsual Clinical Care
Standard 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.
Sponsors
University of Castilla-La Mancha
Newcastle University
Hemiweb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The intervention is open label for participants and care providers. Where possible, outcome assessment should be performed by an independent assessor masked to group assignment.
Intervention model description
Participants will be randomized 1:1 to the eTIPS intervention or usual care. The study will use a parallel-group design. Outcome assessment should be planned as blinded when possible, because the intervention itself cannot be masked.
Eligibility
Sex/Gender
ALL
Age
0 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From identification to enrollment (baseline) | Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate |
| Retention Rate | 6 months (end of intervention) | Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention |
| Adherence Rate | Daily/weekly during 6 months | Days per week and minutes per week of practice recorded in digital diary/app. Success criterion: ≥70% practice days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability (SUS Score) | Post-intervention (6 months) | System Usability Scale (SUS) score for materials and platform. Target: ≥70 points |
| Safety | Throughout 6 months | Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening) |
| Parental Satisfaction | Post-Intervention (6 months) | Likert-scale questionnaire on experience, confidence gained, and recommendation of program |
| Fidelity | Monthly during 6 months | Professional observation of correct eTIPS technique application during scheduled visits |
Outcome results
None listed