About this trial
Primary objective of the study is to compare and evaluate the impact of intensive care of rehabilitation of psychomotor vs. the standard care on adaptive behaviour of children with polyhandicap at 12 months after randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children between 4 and 13 years;
Causal brain injury occurred before the age of 3 years
Severe or deep mental deficiency as defined by IQ < 40, or no evaluable by the psychometric tests
Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders
Disqualifiers
Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;
Planned to move in another clinical setting;
Foreseeable difficulty in the following up in the study.
Trial design
Parallel
Treatments tested in this trial
Intentive rehabilitation
BehavioralIntervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
Routine care
BehavioralIntervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.
Treatment groups
Trial outcomes
Primary outcomes
Evolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Secondary outcomes
Evolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Evolution of development
Brunet-Lézine Scale will be used to evaluate the evolution of development.
Pain evaluation
Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
Durability of acquired cognitive-motor abilities
Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.
Sponsors and contacts
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