NCT Number: NCT07605988
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.
Trial opening soon.
Get Notified0 month–6 month
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: From identification to enrollment (baseline)
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate
Time frame: 6 months (end of intervention)
Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention
Time frame: Daily/weekly during 6 months
Days per week and minutes per week of practice recorded in digital diary/app. Success criterion: ≥70% practice days
Time frame: Post-intervention (6 months)
System Usability Scale (SUS) score for materials and platform. Target: ≥70 points
Time frame: Throughout 6 months
Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
Time frame: Post-Intervention (6 months)
Likert-scale questionnaire on experience, confidence gained, and recommendation of program
Time frame: Monthly during 6 months
Professional observation of correct eTIPS technique application during scheduled visits
Time frame: Baseline, 3 months, 6 months, 12 months
Video-based observational assessment of unimanual and bimanual hand function
Time frame: Baseline, 3 months, 6 months
Structured observation of fine and gross motor patterns
Time frame: Baseline, 3 months, 6 months
Neurological and functional sequelae monitoring post-stroke
Time frame: Baseline, 3 months, 6 months, 12 months
Standardized assessment of cognitive, motor and socio-emotional development in children from 1 to 42 months.
Time frame: Baseline, 3 months, 6 months
Standardized neurological assessment for infants 2-24 months evaluating motor and neurological development
Time frame: Baseline, 3 months, 6 months
Questionnaire measuring parental perception of competence in child care and education
Time frame: Baseline, 3 months, 6 months
Brief scale measuring psychological and emotional well-being in primary caregivers
Time frame: Baseline, 6 months
Measures family perception of empowerment in caring for and supporting child with special needs
Time frame: Baseline, 3 months, 6 months
10-item self-report screening for postpartum depressive symptoms (cut-off ≥10/12). Spanish validated
Time frame: Baseline, 3 months, 6 months
36-item measure of parental stress across 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child
Time frame: Baseline, 3 months, 6 months
25-item questionnaire assessing mother-infant bonding quality. Detects rejection, anger, infantification (cut-off ≥12 factor 1)
University of Castilla-La Mancha
Other
Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
Acronym: eTIPS-ES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
