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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04280458
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Marie-Christine ROUSSEAU, MD
Phone +33 (4) 94 38 08 17
Email marie-Christine.rousseau@aphp.fr
Status Recruiting
Phase N/A
Start date June 20, 2022
Completion date January 2026

See also
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Completed NCT02510846 - Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilities and on the Quality of Life and Feelings of Caregivers N/A
Not yet recruiting NCT06222112 - Experience Life, Needs and Expectations of Families of Older Polyhandiccaped Persons