Play-based rehabilitation for children with cerebral palsy
Italian Cp eArly REhabilitation (iCARE)
IRCCS Eugenio Medea · NCT06737471
This study is testing whether different schedules of play-based rehabilitation can help children with cerebral palsy improve their skills and overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 36 Months to 5 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea (other) |
| Locations | 6 sites (Como, Como and 5 other locations) |
| Trial ID | NCT06737471 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of play-based rehabilitation delivered as usual care for children with cerebral palsy. It compares two formats of rehabilitation: intensive care, which consists of three daily sessions for five days a week over three weeks, and extensive care, which includes three sessions per week for 15 weeks. The aim is to determine if the delivery format impacts the rehabilitation outcomes in this population. The study is conducted in rehabilitation centers that provide both intensive and extensive care.
Who should consider this trial
Good fit: Ideal candidates are children aged between 6 months and 5 years diagnosed with cerebral palsy due to various neurological conditions.
Not a fit: Patients with profound deafness, severe visual impairments, neurodegenerative diseases, acquired brain injuries, or brain tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for children with cerebral palsy, potentially improving their motor and cognitive outcomes.
How similar studies have performed: While few studies have examined the efficacy of rehabilitation in this population, the approach of comparing intensive and extensive care formats is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Como, Como and 5 other locations
- Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno — Como, Como, Italy (RECRUITING)
- Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno e Residenziale — Bosisio Parini, Lecco, Italy (RECRUITING)
- Scientific IRCCS, E. Medea — Bosisio Parini, Lecco, Italy (RECRUITING)
- Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale — Sesto San Giovanni, Milano, Italy (RECRUITING)
- Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale — Carate Brianza, Monza E Brianza, Italy (RECRUITING)
- Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno — Vedano Olona, Varese, Italy (RECRUITING)
Study contacts
- Study coordinator: Sandra Strazzer, MD
- Email: sandra.strazzer@lanostrafamiglia.it
- Phone: +39031877111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, cerebral-palsy, children, pediatric, intervention, rehabilitation, motor, cognitive