NCT07605988Not yet recruiting
Spanish eTIPS for Early Therapy in Perinatal Stroke
Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- University of Castilla-La Mancha
- Diseases
- Stroke
- NCT number
- NCT07605988
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another clinical trial with interfering treatment
Other illness
- Known progressive neurodegenerative disorder or severe medical comorbidity preventing participation (e.g., ventilation-dependent respiratory failure)
Other
- Extensive bilateral intracerebral lesion making lateralized intervention irrelevant
Who the study is looking for
- 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
Age in the registry: 0 months to 6 months · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.