Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on
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.
| Condition(s) | Polyhandicap |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 o |
| Ages | 4 Years to 13 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Hyères, Var, France |
| Start date | 2022-06-20 |
| NCT ID | NCT04280458 |
| Official listing | https://clinicaltrials.gov/study/NCT04280458 |