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Recruiting Not applicable

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

NCT04280458 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-06-20
Last updated
2025-03-19

Condition(s) studied

Polyhandicap

Investigational drug(s) / intervention(s)

Intentive rehabilitationRoutine care

Intentive rehabilitation: Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.

Routine care: Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
13 Years
Healthy volunteers
No
Inclusion Criteria: * Children between 4 and 13 years; * With polyhandicap defined by association of the 5 following criteria: * Causal brain injury occurred before the age of 3 years * Severe or deep mental deficiency as defined by IQ \< 40, or no evaluable by the psychometric tests * Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders * Score of Gross Motor Function Classification System \[Palisano 1997\] is III, IV or V * Score of Functional Independence Measure \< 50; * Hospitalization in a clinical setting participating to the study; * Beneficiary of a social protection; * Written consent signed by personnel holding parental authority or legal representative. Exclusion Criteria: * Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases; * Planned to move in another clinical setting; * Foreseeable difficulty in the following up in the study.

Primary outcome measure(s)

  • Evolution of adaptative behaviour — At 12 months
    Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

Trial sites (1)

FacilityCityRegionStatus
Hôpital San Salvadour Hyères Var Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04280458 on ClinicalTrials.gov ↗ ← All trials in France