Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Polyhandicap
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 4 years and 13 years
Gender
Both males and females

Description

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 ...

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.

Tracking Information

NCT #
NCT04280458
Collaborators
Not Provided
Investigators
Principal Investigator: Marie-Christine ROUSSEAU, MD Polyhandicap adultes San Salvadour, APHP
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