Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

Study Overview
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Brief Summary
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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.

Detailed Description
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As secondary objectives, the study aims to: 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. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization. study the concordance between the Vineland scale and the Brunet-Lézine scale.

Official Title
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Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap

Conditions
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Polyhandicap

Intervention / Treatment
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* Behavioral: Intentive rehabilitation
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 4 and 13 years; With polyhandicap defined by association of the 5 following criteria: 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 Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V Score of Functional Independence Measure < 50; Hospitalization in a clinical setting participating to the study; Beneficiary of a social protection; Written consent signed by personnel holding parental authority or legal representative. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>patients will receive intensive care of rehabilitation of psychomotor | Behavioral: Intentive rehabilitation<br>* Intervention included: psychomotor 5 hours/week ±30 minutes kinesitherapy 1.5 hour/week ±20 minutes during 12 months.<br>|
| Active Comparator: Control group<br>patients will receive standard care | Behavioral: Routine care<br>* Intervention included: kinesitherapy 0.5 hour/week ±10 minutes psychomotor 30 min/week ±10 minutes during 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of adaptative behaviour | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of adaptative behaviour | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. | At 6 months | 
| Evolution of development | Brunet-Lézine Scale will be used to evaluate the evolution of development. | At 12 months | 
| Pain evaluation | Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain. | At 12 months | 
| Durability of acquired cognitive-motor abilities | Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities. | 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. | at 18 months | 
| Quality of family's life surveys | WHOQOL-Bref questionnaire will be used. | 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. | At baseline and 12 months | 
| Burden surveys | Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents. | At baseline and 12 months | 
| Clinical Global Impressions by caregivers | Clinical Global Impressions (CGI) Scale will be used by caregivers. | 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. | At baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children polyhandicap, rehabilitation, psychomotor, cognitive-motor, adaptative skill