Cp eArly REhabilitation

Condition(s) studied

Investigational drug(s) / intervention(s)

Intensive 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.

Extensive 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.

Study 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

Primary outcome measure(s)

• Functional Independence Measure for children (WeeFIM) — At baseline, immediately after the intervention and at an 8-month follow-up.
  The WeeFIM scale assesses the ability of a child in day-to-day functional tasks related to the 3 following main domains: self-care, mobility and cognition. It is composed of 18 items, each evaluating child's performance on a 7-point ordinal scale. WeeFIM is usually adopted in typically developing children aged 6 months-7 years. However, for children with developmental disabilities, the scale can be used up to 21 years.
• The Gross Motor Function Measure 88 (GMFM-88) — At baseline, immediately after the intervention and at an 8-month follow-up.
  The Gross Motor Function Measure 88 (GMFM-88) allows measuring changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in 5 dimensions 1) Lying and Rolling; 2) Sitting; 3) Crawling and Kneeling; 4) Standing; 5) Walking, Running and Jumping. Items evaluate performance on a 3-point Likert scale. Higher scores indicate better performance.

Trial sites (6)

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