Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-29 @ 6:06 AM
Study NCT ID:
NCT04280458
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REEDUC-PLH
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A00800-39 | REGISTRY | IDRCB | View |