Spanish eTIPS for Early Therapy in Perinatal Stroke

Официальное название

Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое eTIPS
  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
• Поведенческое Usual 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 guid

Первичные конечные точки

• Recruitment Rate [Срок оценки: From identification to enrollment (baseline)]
• Retention Rate [Срок оценки: 6 months (end of intervention)]
• Adherence Rate [Срок оценки: Daily/weekly during 6 months]

Вторичные конечные точки (4)

• Usability (SUS Score) [Срок оценки: Post-intervention (6 months)]
• Safety [Срок оценки: Throughout 6 months]
• Parental Satisfaction [Срок оценки: Post-Intervention (6 months)]
• Fidelity [Срок оценки: Monthly during 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07605988 · Spanish eTIPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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