RecruitingNCT06737471

Cp eArly REhabilitation

Italian Cp eArly REhabilitation (iCARE)


Sponsor

IRCCS Eugenio Medea

Enrollment

96 participants

Start Date

May 21, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 36 MonthsMax Age: 5 Years

Inclusion Criteria2

  • 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 Criteria2

  • profound deafness and/or severe hypovisus/blindness;
  • a diagnosis of neurodegenerative diseases, acquired brain injury or brain tumor.

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Interventions

OTHERIntensive rehabilitation treatment

A 3-hour daily rehabilitation treatment will be delivered to each patient 5 days a week for 5 weeks (45 hours) in the care units of the Hospital. Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.

OTHERExtensive rehabilitation treatment

A 3-hour weekly rehabilitation treatment will be delivered to each patient for 15 weeks (45 hours) in an outpatient setting. Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.


Locations(6)

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno

Como, Como, Italy

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno e Residenziale

Bosisio Parini, Lecco, Italy

Scientific IRCCS, E. Medea

Bosisio Parini, Lecco, Italy

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Sesto San Giovanni, Milano, Italy

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Carate Brianza, Monza E Brianza, Italy

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno

Vedano Olona, Varese, Italy

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NCT06737471


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