Spanish eTIPS for Early Therapy in Perinatal Stroke (eTIPS-ES)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：eTIPS Intervention
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.
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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
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アクティブコンパレータ：Usual Care
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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rate
時間枠：From identification to enrollment (baseline)
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Proportion of eligible infants identified in neonatology/pediatric neurology who accept participation.
Success criterion: ≥70% acceptance rate
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From identification to enrollment (baseline)
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Retention Rate
時間枠：6 months (end of intervention)
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Percentage of families completing the 6-month follow-up.
Success criterion: ≥80% retention
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6 months (end of intervention)
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Adherence Rate
時間枠：Daily/weekly during 6 months
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Days per week and minutes per week of practice recorded in digital diary/app.
Success criterion: ≥70% practice days
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Daily/weekly during 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Usability (SUS Score)
時間枠：Post-intervention (6 months)
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System Usability Scale (SUS) score for materials and platform.
Target: ≥70 points
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Post-intervention (6 months)
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Safety
時間枠：Throughout 6 months
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Adverse events or incidents related to intervention (excessive fatigue, persistent rejection, feeding worsening)
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Throughout 6 months
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Parental Satisfaction
時間枠：Post-Intervention (6 months)
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Likert-scale questionnaire on experience, confidence gained, and recommendation of program
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Post-Intervention (6 months)
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Fidelity
時間枠：Monthly during 6 months
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Professional observation of correct eTIPS technique application during scheduled visits
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Monthly during 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hand Assessment for Infants (HAI)
時間枠：Baseline, 3 months, 6 months, 12 months
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Video-based observational assessment of unimanual and bimanual hand function
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Baseline, 3 months, 6 months, 12 months
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Infant Motor Profile (IMP)
時間枠：Baseline, 3 months, 6 months
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Structured observation of fine and gross motor patterns
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Baseline, 3 months, 6 months
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Paediatric Stroke Outcome Measure (PSOM)
時間枠：Baseline, 3 months, 6 months
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Neurological and functional sequelae monitoring post-stroke
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Baseline, 3 months, 6 months
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Bayley Scales of Infant Development (BSID-IV)
時間枠：Baseline, 3 months, 6 months, 12 months
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Standardized assessment of cognitive, motor and socio-emotional development in children from 1 to 42 months.
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Baseline, 3 months, 6 months, 12 months
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Hammersmith Infant Neurological Examination (HINE)
時間枠：Baseline, 3 months, 6 months
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Standardized neurological assessment for infants 2-24 months evaluating motor and neurological development
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Baseline, 3 months, 6 months
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Parenting Sense of Competence (PSOC)
時間枠：Baseline, 3 months, 6 months
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Questionnaire measuring parental perception of competence in child care and education
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Baseline, 3 months, 6 months
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Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
時間枠：Baseline, 3 months, 6 months
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Brief scale measuring psychological and emotional well-being in primary caregivers
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Baseline, 3 months, 6 months
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Family Empowerment Scale
時間枠：Baseline, 6 months
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Measures family perception of empowerment in caring for and supporting child with special needs
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Baseline, 6 months
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Edinburgh Postnatal Depression Scale (EPDS)
時間枠：Baseline, 3 months, 6 months
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10-item self-report screening for postpartum depressive symptoms (cut-off ≥10/12).
Spanish validated
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Baseline, 3 months, 6 months
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Parenting Stress Index - Short Form (PSI-SF)
時間枠：Baseline, 3 months, 6 months
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36-item measure of parental stress across 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child
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Baseline, 3 months, 6 months
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Postpartum Bonding Questionnaire (PBQ)
時間枠：Baseline, 3 months, 6 months
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25-item questionnaire assessing mother-infant bonding quality.
Detects rejection, anger, infantification (cut-off ≥12 factor 1)
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Baseline, 3 months, 6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Spanish eTIPS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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