Early family-centered intervention for infants at high risk of cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the GO-PLAY intervention program, which is designed to enhance early motor development in infants identified as being at high risk for cerebral palsy. The program is family-centered and involves home-based activities supported by parents and supervised by specialist therapists. Participants will be randomly assigned to receive either the GO-PLAY intervention in addition to standard care or standard care alone. The study aims to recruit approximately 60 infants from multiple sites in Denmark, focusing on those with early signs of cerebral palsy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting

Study contacts

• Study coordinator: Mette Johansen
• Email: m.johansen1@rn.dk
• Phone: +4530473915

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.