An interventional study of eTIPS and Usual Clinical Care in Perinatal Stroke and Risk of Unilateral Cerebral Palsy, Early Parent-delivered Home-based Intervention and Spanish Cross-cultural Adaptation of eTIPS, sponsored by University of Castilla-La Mancha. Not yet recruiting. Open to participants aged 0 Months to 6 Months. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: eTIPS
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
Behavioral: Usual Clinical Care
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.
Recruitment Rate
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate
Time frame: From identification to enrollment (baseline)
Retention Rate
Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention
Time frame: 6 months (end of intervention)
Adherence Rate
Days per week and minutes per week of practice recorded in digital diary/app. Success criterion: ≥70% practice days
Time frame: Daily/weekly during 6 months
Usability (SUS Score)
System Usability Scale (SUS) score for materials and platform. Target: ≥70 points
Time frame: Post-intervention (6 months)
Safety
Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
Time frame: Throughout 6 months
Parental Satisfaction
Likert-scale questionnaire on experience, confidence gained, and recommendation of program
Time frame: Post-Intervention (6 months)
Fidelity
Professional observation of correct eTIPS technique application during scheduled visits
Time frame: Monthly during 6 months
Hand Assessment for Infants (HAI)
Video-based observational assessment of unimanual and bimanual hand function
Time frame: Baseline, 3 months, 6 months, 12 months
Infant Motor Profile (IMP)
Structured observation of fine and gross motor patterns
Time frame: Baseline, 3 months, 6 months
Paediatric Stroke Outcome Measure (PSOM)
Neurological and functional sequelae monitoring post-stroke
Time frame: Baseline, 3 months, 6 months
Bayley Scales of Infant Development (BSID-IV)
Standardized assessment of cognitive, motor and socio-emotional development in children from 1 to 42 months.
Time frame: Baseline, 3 months, 6 months, 12 months
Hammersmith Infant Neurological Examination (HINE)
Standardized neurological assessment for infants 2-24 months evaluating motor and neurological development
Time frame: Baseline, 3 months, 6 months
Parenting Sense of Competence (PSOC)
Questionnaire measuring parental perception of competence in child care and education
Time frame: Baseline, 3 months, 6 months
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Brief scale measuring psychological and emotional well-being in primary caregivers
Time frame: Baseline, 3 months, 6 months
Family Empowerment Scale
Measures family perception of empowerment in caring for and supporting child with special needs
Time frame: Baseline, 6 months
Edinburgh Postnatal Depression Scale (EPDS)
10-item self-report screening for postpartum depressive symptoms (cut-off ≥10/12). Spanish validated
Time frame: Baseline, 3 months, 6 months
Parenting Stress Index - Short Form (PSI-SF)
36-item measure of parental stress across 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child
Time frame: Baseline, 3 months, 6 months
Postpartum Bonding Questionnaire (PBQ)
25-item questionnaire assessing mother-infant bonding quality. Detects rejection, anger, infantification (cut-off ≥12 factor 1)
Time frame: Baseline, 3 months, 6 months
No study locations are listed for this record.
Plan to share: No — No plan to share individual participant data (IPD). Data will be stored securely at Universidad de Castilla-La Mancha following Spanish and EU data protection regulations (RGPD/LOPDGDD). Aggregate results will be published in peer-reviewed journals.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Castilla-La Mancha →