NCT05883969 GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy
| NCT ID | NCT05883969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-04-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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) intervention program added to standard care is superior to standard care alone is evaluated. The investigators will include infants from the Cerebral Palsy - Early Diagnosis and Intervention Trial (CP-EDIT registered separately at ClinicalTrials) and collect data at baseline, after intervention and at follow up when the children are 2 years corrected age. The hypotheses are that the GO-PLAY intervention is more effective than standard care when the children are re-evaluated at the end of 6 months of intervention and that the parents involved in the GO-PLAY intervention will exhibit less signs of stress and anxiety and perceive the services that they are receiving as family-centered to a greater extent than parents of children receiving standard care. Discussion. Approximately half of all infants with high risk of CP display high risk indicators identifiable by early screening before 5 months of age described as the newborn detectable risk pathway. The other half of all infants with CP are detected by parents, caregivers or health care professionals when displaying delayed motor milestones (e.g. hand asymmetry or not sitting at 9 months) and described as infant detectable risk pathway. There is a need to investigate if early intervention is effective in all infants with high suspicion of CP, also the ones with unremarkable neonatal history. Further, a systematic early intervention has not been tested in infants at high risk of CP in Denmark, where public health services include physiotherapy free of charge for infants with CP.
Eligibility 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.
Contact & Investigator
Christina Hoi-Hansen, Professor
STUDY CHAIR
Department of Paediatrics, University Hospital Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05883969 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 12 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05883969 currently recruiting?
Yes, NCT05883969 is actively recruiting participants. Contact the research team at m.johansen1@rn.dk for enrollment information.
Where is the NCT05883969 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark.
Who is sponsoring the NCT05883969 clinical trial?
NCT05883969 is sponsored by Rigshospitalet, Denmark. The principal investigator is Christina Hoi-Hansen, Professor at Department of Paediatrics, University Hospital Rigshospitalet, Denmark. The trial plans to enroll 60 participants.
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