Spanish eTIPS for Early Therapy in Perinatal Stroke

NCT07605988 | Not Yet Recruiting

• 1 other identifier: Spanish eTIPS
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perinatal Stroke and Risk of Unilateral Cerebral Palsy; Early Parent-delivered Home-based Intervention; Spanish Cross-cultural Adaptation of eTIPS

Keywords

eTIPS; perinatal stroke; unilateral cerebral palsy; early intervention; infant rehabilitation

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate

  From identification to enrollment (baseline)

• Retention Rate

  Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention

  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

  Daily/weekly during 6 months

Secondary Outcomes (4)

• Usability (SUS Score)

  Post-intervention (6 months)

• Safety

  Throughout 6 months

• Parental Satisfaction

  Post-Intervention (6 months)

• Fidelity

  Monthly during 6 months

Other Outcomes (11)

• Hand Assessment for Infants (HAI)

  Baseline, 3 months, 6 months, 12 months

• Infant Motor Profile (IMP)

  Baseline, 3 months, 6 months

• Paediatric Stroke Outcome Measure (PSOM)

  Baseline, 3 months, 6 months

Study Arms (2)

eTIPS Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

eTIPS BEHAVIORAL

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

eTIPS Intervention

Usual Clinical Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Newcastle University: collaborator
• Hemiweb: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The intervention is open label for participants and care providers. Where possible, outcome assessment should be performed by an independent assessor masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to the eTIPS intervention or usual care. The study will use a parallel-group design. Outcome assessment should be planned as blinded when possible, because the intervention itself cannot be masked.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share