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.
As secondary objectives, the study aims to: 1. compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on: * result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization; * result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization; * the pain evaluation at 12 months after randomization; * the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization); * the quality of life of the patients' family or relatives at 12 months after randomization; * the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization. 2. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization. 3. study the concordance between the Vineland scale and the Brunet-Lézine scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.
Hôpital San Salvadour
Hyères, Var, France
RECRUITINGEvolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Time frame: At 12 months
Evolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Time frame: At 6 months
Evolution of development
Brunet-Lézine Scale will be used to evaluate the evolution of development.
Time frame: At 12 months
Pain evaluation
Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
Time frame: At 12 months
Durability of acquired cognitive-motor abilities
Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.
Time frame: at 18 months
Durability of acquired cognitive-motor abilities
The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.
Time frame: at 18 months
Quality of family's life surveys
WHOQOL-Bref questionnaire will be used.
Time frame: At baseline and 12 months
Emotional distress measurement
Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents.
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Time frame: At baseline and 12 months
Burden surveys
Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.
Time frame: At baseline and 12 months
Clinical Global Impressions by caregivers
Clinical Global Impressions (CGI) Scale will be used by caregivers.
Time frame: At baseline and 12 months
Quality of caregivers' life
The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.
Time frame: At baseline and 12 months