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A Randomized Controlled Trial of Hybrid Environmental Enrichment-Based Early Intervention in Infants at Risk of Cerebral Palsy

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Nov 2025 to Jun 1, 2026 Study completion date changed from estimate of Nov 2025 to Aug 1, 2026 · Start date: Sep 5, 2025 to Feb 1, 2026 · Trial completed · 7 more Show 10 more changesShow less
    • Study completion date changed from estimate of Nov 2025 to Aug 1, 2026
    • Start date: Sep 5, 2025 to Feb 1, 2026
    • Trial completed
    • Final enrollment: 34 participants (planned 22)
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 86 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 7 words
  2. Re-verified, no change to tracked fieldsv3
  3. Start date: Aug 5, 2025 to Sep 5, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled trial aims to evaluate the effects of a hybrid environmental enrichment-based early intervention grounded in the Homeostasis-Enrichment-Plasticity (HEP®) Approach in infants at risk of cerebral palsy (CP). Infants aged 4-10 months identified as being at risk for CP through the Prechtl Assessment or brain imaging will be randomly assigned to either a HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period. Outcomes related to functional goal attainment, developmental performance, and parental well-being will be assessed using the Goal Attainment Scaling (GAS), Bayley Scales of Infant and Toddler Development-III (Bayley-III), Test of Sensory Functions in Infants (TSFI), and Depression Anxiety Stress Scales-21 (DASS-21). Feasibility, safety, and caregiver acceptance of the intervention will also be examined.
Trial Details
NCT Number NCT07116148
Lead Sponsor Medipol University
Conditions Infants at Risk of Cerebral Palsy
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov