NCT04280458

Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 4 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polyhandicap

Interventions

Type	Name	Description
BEHAVIORAL	Intentive rehabilitation	Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
BEHAVIORAL	Routine care	Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-02-21
• Last updated: 2025-03-19

Locations

1 site across 1 country: France