Status:
RECRUITING
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Polyhandicap
Eligibility:
All Genders
4-13 years
Phase:
NA
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 ...
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 Vinela...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04280458
Start Date
June 20 2022
End Date
January 1 2026
Last Update
March 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital San Salvadour
Hyères, Var, France, 83407