Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04280458
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.
Study:
NCT04280458
Study Brief:
Protocol Section:
NCT04280458