NCT05883969: GO-PLAY

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

Recruiting now NA Last updated 1 June 2023

What this trial tests

NA trial testing GO-PLAY in Cerebral Palsy in 60 participants. Currently enrolling.

Timeline

1 April 2023

Primary endpoint
30 September 2025

31 March 2028

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 April 2023
Primary completion	30 September 2025
Estimated completion	31 March 2028
Sites	2 locations across Denmark

Drugs / interventions tested

• GO-PLAY
• Usual care

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 3 Months to 12 Months, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.