Clinical Trial

Cp eArly REhabilitation

Study acronym: iCARE
Recruiting
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Record status
This record was last updated May 1, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-12.
Trial Details
NCT Number NCT06737471
Lead Sponsor IRCCS Eugenio Medea
Conditions Cerebral Palsy
Enrollment 96 participants
Start Date 2024-05-21
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-01