Cp eArly REhabilitation
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age36-5
SponsorIRCCS Eugenio Medea
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
profound deafness and/or severe hypovisus/blindness;
a diagnosis of neurodegenerative diseases, acquired brain injury or brain tumor.
Trial population
Children with cerebral palsy aged 6 months to 5 years receiving rehabilitation as usual care will be included in the study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Intensive rehabilitation treatment
Other interventionA 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
Other interventionA 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Extensive rehabilitation treatment1 intervention
Group B: Intensive rehabilitation treatment1 intervention
Trial outcomes
Primary outcomes
1
Functional Independence Measure for children (WeeFIM)
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.
Time frame
At baseline, immediately after the intervention and at an 8-month follow-up.2
The Gross Motor Function Measure 88 (GMFM-88)
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.
Time frame
At baseline, immediately after the intervention and at an 8-month follow-up.Secondary outcomes
1
The Behavior Rating Inventory of Executive Function-Preschool Version -parent form
The Behavior Rating Inventory of Executive Function-Preschool Version -parent form is a parent report assessing specific components of executive functions through observable everyday behaviors in children aged 2 to 5:11 years. It has 5 clinical scales (Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize), 3 composite indices (Inhibitory Self-Control Index (ISCI), Flexibility Index (FI), Emergent Metacognition Index (EMI)), and an overall composite score known as the Global Executive Composite (GEC).
Time frame
At baseline, immediately after the intervention and at an 8-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov