Spanish eTIPS for Early Therapy in Perinatal Stroke (eTIPS-ES)
Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: eTIPS Intervention
Participants assigned to this arm will receive the Spanish-adapted eTIPS program, a parent-delivered, home-based early intervention for infants with perinatal stroke or risk of unilateral cerebral palsy.
Families will receive training, adapted materials, and ongoing support to integrate lateralized therapeutic activities into daily routines from enrollment until corrected age 6 months.
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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
|
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Aktywny komparator: Usual Care
Participants assigned to this arm will receive usual clinical care according to local practice, including standard neonatal, neurological, and rehabilitation follow-up.
This arm serves as the comparator for feasibility, acceptability, and exploratory outcome assessment
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Recruitment Rate
Ramy czasowe: From identification to enrollment (baseline)
|
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation.
Success criterion: ≥70% acceptance rate
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From identification to enrollment (baseline)
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Retention Rate
Ramy czasowe: 6 months (end of intervention)
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Percentage of families completing the 6-month follow-up.
Success criterion: ≥80% retention
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6 months (end of intervention)
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Adherence Rate
Ramy czasowe: Daily/weekly during 6 months
|
Days per week and minutes per week of practice recorded in digital diary/app.
Success criterion: ≥70% practice days
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Daily/weekly during 6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Usability (SUS Score)
Ramy czasowe: Post-intervention (6 months)
|
System Usability Scale (SUS) score for materials and platform.
Target: ≥70 points
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Post-intervention (6 months)
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Safety
Ramy czasowe: Throughout 6 months
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Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
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Throughout 6 months
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Parental Satisfaction
Ramy czasowe: Post-Intervention (6 months)
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Likert-scale questionnaire on experience, confidence gained, and recommendation of program
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Post-Intervention (6 months)
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Fidelity
Ramy czasowe: Monthly during 6 months
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Professional observation of correct eTIPS technique application during scheduled visits
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Monthly during 6 months
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Hand Assessment for Infants (HAI)
Ramy czasowe: Baseline, 3 months, 6 months, 12 months
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Video-based observational assessment of unimanual and bimanual hand function
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Baseline, 3 months, 6 months, 12 months
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Infant Motor Profile (IMP)
Ramy czasowe: Baseline, 3 months, 6 months
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Structured observation of fine and gross motor patterns
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Baseline, 3 months, 6 months
|
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Paediatric Stroke Outcome Measure (PSOM)
Ramy czasowe: Baseline, 3 months, 6 months
|
Neurological and functional sequelae monitoring post-stroke
|
Baseline, 3 months, 6 months
|
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Bayley Scales of Infant Development (BSID-IV)
Ramy czasowe: Baseline, 3 months, 6 months, 12 months
|
Standardized assessment of cognitive, motor and socio-emotional development in children from 1 to 42 months.
|
Baseline, 3 months, 6 months, 12 months
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Hammersmith Infant Neurological Examination (HINE)
Ramy czasowe: Baseline, 3 months, 6 months
|
Standardized neurological assessment for infants 2-24 months evaluating motor and neurological development
|
Baseline, 3 months, 6 months
|
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Parenting Sense of Competence (PSOC)
Ramy czasowe: Baseline, 3 months, 6 months
|
Questionnaire measuring parental perception of competence in child care and education
|
Baseline, 3 months, 6 months
|
|
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Ramy czasowe: Baseline, 3 months, 6 months
|
Brief scale measuring psychological and emotional well-being in primary caregivers
|
Baseline, 3 months, 6 months
|
|
Family Empowerment Scale
Ramy czasowe: Baseline, 6 months
|
Measures family perception of empowerment in caring for and supporting child with special needs
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Baseline, 6 months
|
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Edinburgh Postnatal Depression Scale (EPDS)
Ramy czasowe: Baseline, 3 months, 6 months
|
10-item self-report screening for postpartum depressive symptoms (cut-off ≥10/12).
Spanish validated
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Baseline, 3 months, 6 months
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Parenting Stress Index - Short Form (PSI-SF)
Ramy czasowe: Baseline, 3 months, 6 months
|
36-item measure of parental stress across 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child
|
Baseline, 3 months, 6 months
|
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Postpartum Bonding Questionnaire (PBQ)
Ramy czasowe: Baseline, 3 months, 6 months
|
25-item questionnaire assessing mother-infant bonding quality.
Detects rejection, anger, infantification (cut-off ≥12 factor 1)
|
Baseline, 3 months, 6 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Spanish eTIPS
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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