Polyhandicap
Conditions
Keywords
children polyhandicap, rehabilitation, psychomotor, cognitive-motor, adaptative skill
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.
Interventions
BEHAVIORALIntentive rehabilitation
Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
BEHAVIORALRoutine care
Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of adaptative behaviour | At 12 months | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of adaptative behaviour | At 6 months | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. |
| Pain evaluation | At 12 months | Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain. |
| Durability of acquired cognitive-motor abilities | at 18 months | Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities. |
| Quality of family's life surveys | At baseline and 12 months | WHOQOL-Bref questionnaire will be used. |
| Evolution of development | At 12 months | Brunet-Lézine Scale will be used to evaluate the evolution of development. |
| Burden surveys | At baseline and 12 months | Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents. |
| Clinical Global Impressions by caregivers | At baseline and 12 months | Clinical Global Impressions (CGI) Scale will be used by caregivers. |
| Quality of caregivers' life | At baseline and 12 months | The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers. |
| Emotional distress measurement | At baseline and 12 months | Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents. |
Countries
France
Contacts
Primary ContactMarie-Christine ROUSSEAU, MD
Outcome results
None listed