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GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy

RecruitingNAAges 3 Months - 12 MonthsAllCopenhagen University Hospital, Rigshospitalet
NCT05883969 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background. Early diagnosis of cerebral palsy (CP) is important to enable appropriate intervention at a time when neuroplasticity is at its highest. Early intervention with focus on family-centered, home-based, parent-involved, and supervised by specialist therapists show positive cognitive and motor outcomes. This study adhere to international guidelines for early diagnosis and intervention, and include community therapists to ensure regular follow-up during and after the intervention period. The aim of the current study is to compare the effectiveness of an early intervention program added to standard care, relative to standard care alone, on the early motor development in children from both a newborn and infant detectable risk pathway in a Danish multi-site setting. Methods. In a randomized, controlled trial the response to the GO-PLAY (Goal Oriented ParentaL supported home ActivitY

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📋 Eligibility rules (as published)
Inclusion Criteria: Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B: A. any two of the following: * Neuroimaging predictive of a motor disability including the involvement of one or more of the following structures: sensori-motor cortex, basal ganglia, posterior limb of the internal capsule, pyramidal tracts. * General Movement Assessment with absent fidgety GMs at fidgety age * HINE scores \<57 at 3months or \<60 at 6months or \<63 at 9 months or \<66 at 12 months B. both of the following: * Unilateral brain injury on neuroimaging (MRI or ultrasound) predictive of CP * Clinical signs of asymmetry Exclusion Criteria: * Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP * Infants with other disability diagnoses e.g. Down Syndrome. * children for whom neither parent is fluent in Danish.
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What it tests

  • GO-PLAY
  • Usual care
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Where

2 sites
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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