Early family-centered intervention for infants at high risk of cerebral palsy
Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy: Protocol for the Randomized Controlled GO-PLAY Trial
This study is testing a new program called GO-PLAY to see if it can help infants at high risk for cerebral palsy develop better motor skills with support from their families and therapists.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Months to 12 Months |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 2 sites (Aalborg and 1 other locations) |
| Trial ID | NCT05883969 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 3 to 12 months who show early signs of cerebral palsy or have neuroimaging predictive of motor disability.
Not a fit: Patients with progressive or neurodegenerative disorders, genetic disorders not associated with cerebral palsy, or other disabilities such as Down Syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved motor development outcomes for infants at high risk of cerebral palsy.
How similar studies have performed: Other studies have shown positive outcomes with early intervention programs for infants at risk of cerebral palsy, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.