Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polyhandicap
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Evolution of adaptative behaviour
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evolution of adaptative behaviour
Time Frame: At 12 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Secondary Outcomes
- Evolution of adaptative behaviour(At 6 months)
- Evolution of development(At 12 months)
- Pain evaluation(At 12 months)
- Durability of acquired cognitive-motor abilities(at 18 months)
- Quality of family's life surveys(At baseline and 12 months)
- Burden surveys(At baseline and 12 months)
- Clinical Global Impressions by caregivers(At baseline and 12 months)
- Quality of caregivers' life(At baseline and 12 months)
- Emotional distress measurement(At baseline and 12 months)