| NCT ID | NCT06737471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 96 participants in total. It began in 2024-05-21 with a primary completion date of 2025-12-31.
⚠ 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
The present study aims to investigate the efficacy of play-based rehabilitation delivered as usual care in children with cerebral palsy in a rehabilitation center offering both intensive and extensive care. Up to now, few studies described and examined treatments' efficacy in this population. Secondary aim of the study will be comparing the efficacy of the two rehabilitation treatment formats (intensive vs. extensive), which will have the same dose (sessions delivered) and ingredients (content). The intervention delivered as extensive care (3 sessions per week per 15 weeks) will be offered in community rehabilitation centers (Centri di Riabilitazione-CDR), while the one delivered as intensive care (3 sessions daily per 5 days a week for 3 weeks) will be offered to children admitted to hospital inpatient care units. This comparison allows verifying if delivery time may affect outcomes.
Eligibility Criteria
Inclusion Criteria: * age between 6 months (corrected age in case of prematurity) and 5 years; * a diagnosis of cerebral palsy due to perinatal suffering, neurological syndromes, rare diseases with neurological impairment or congenital diseases of unknown nature. Exclusion Criteria: * profound deafness and/or severe hypovisus/blindness; * a diagnosis of neurodegenerative diseases, acquired brain injury or brain tumor.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06737471 clinical trial?
This trial is open to participants of all sexes, aged 36 Months or older, up to 5 Years, 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 NCT06737471 currently recruiting?
Yes, NCT06737471 is actively recruiting participants. Contact the research team at sandra.strazzer@lanostrafamiglia.it for enrollment information.
Where is the NCT06737471 trial being conducted?
This trial is being conducted at Como, Italy, Bosisio Parini, Italy, Bosisio Parini, Italy, Sesto San Giovanni, Italy and 2 additional locations.
Who is sponsoring the NCT06737471 clinical trial?
NCT06737471 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 96 participants.
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