Perinatal Stroke and Risk of Unilateral Cerebral PalsyeTIPS-ESNCT07605988
Spanish eTIPS for Early Therapy in Perinatal Stroke
A study testing eTIPS and Usual Clinical Care in people with Perinatal Stroke and Risk of Unilateral Cerebral Palsy and Early Parent-delivered Home-based Intervention, run by University of Castilla-La Mancha.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Perinatal Stroke and Risk of Unilateral Cerebral Palsy, Early Parent-delivered Home-based Intervention, Spanish Cross-cultural Adaptation of eTIPS
- What is being tested?
- eTIPS and Usual Clinical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
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.
Read the detailed description
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.
- Conditions
- Perinatal Stroke and Risk of Unilateral Cerebral Palsy, Early Parent-delivered Home-based Intervention, Spanish Cross-cultural Adaptation of eTIPS
- Being tested
- eTIPS, Usual Clinical Care
- Keywords
- eTIPS, perinatal stroke, unilateral cerebral palsy, early intervention, infant rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTIPSBehavioural
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
Usual Clinical CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Usual Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate
Measured: From identification to enrollment (baseline)
Retention Rate
Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention
Measured: 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
Measured: Daily/weekly during 6 months
Secondary outcomes (4)
Usability (SUS Score)
System Usability Scale (SUS) score for materials and platform. Target: ≥70 points
Measured: Post-intervention (6 months)
Safety
Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
Measured: Throughout 6 months
Parental Satisfaction
Likert-scale questionnaire on experience, confidence gained, and recommendation of program
Measured: Post-Intervention (6 months)
Fidelity
Professional observation of correct eTIPS technique application during scheduled visits
Measured: Monthly during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Stroke and Risk of Unilateral Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Hemiweb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605988
- Sponsor's protocol ID
- Spanish eTIPS
- Acronym
- eTIPS-ES
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
- ClinicalTrials.gov ID
- NCT07605988
- Acronym / sponsor ID
- eTIPS-ES / Spanish eTIPS
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Newcastle University, Hemiweb
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| eTIPS Intervention | Experimental | Behavioral: eTIPSParticipants 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. |
| Usual Care | Active comparator | Behavioral: Usual Clinical CareParticipants 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 |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eTIPSParent-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 | Behavioural | eTIPS Intervention |
| Usual Clinical CareStandard 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. | Behavioural | Usual Care |
Primary outcome
Recruitment Rate
Time frame: From identification to enrollment (baseline)
Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation. Success criterion: ≥70% acceptance rate
Retention Rate
Time frame: 6 months (end of intervention)
Percentage of families completing the 6-month follow-up. Success criterion: ≥80% retention
Adherence Rate
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
4 secondary outcomes
Usability (SUS Score)
Time frame: Post-intervention (6 months)
Safety
Time frame: Throughout 6 months
Parental Satisfaction
Time frame: Post-Intervention (6 months)
Fidelity
Time frame: Monthly during 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing eTIPS and Usual Clinical Care in people with Perinatal Stroke and Risk of Unilateral Cerebral Palsy and Early Parent-delivered Home-based Intervention, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From identification to enrollment (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.