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

Recruiting now · Not applicable

Conditions studied: Polyhandicap

In brief

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.

Key facts

Study ID

NCT04280458

Run by

Assistance Publique - Hôpitaux de Paris

People needed

62

Starts

2022-06-20

Expected to finish

2026-01-01

Last updated by the study team

2025-03-19

Who can join

Age: 4 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hôpital San Salvadour — Hyères, Var, France (enrolling)

Full record on ClinicalTrials.gov

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