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Search / Trial NCT04280458

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 20, 2020

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Children Polyhandicap Rehabilitation Psychomotor Cognitive Motor Adaptative Skill

ClinConnect Summary

This clinical trial is focused on helping children with polyhandicap, a condition that involves multiple disabilities, by comparing two types of rehabilitation programs. The main goal is to see how intensive psychomotor rehabilitation—an approach that helps improve movement and cognitive (thinking) abilities—affects the children's adaptive behavior over a 12-month period, compared to standard care. Adaptive behavior refers to how well a child can manage everyday tasks and interact with others.

To participate in this study, children aged 4 to 13 years who have been diagnosed with polyhandicap may be eligible if they meet certain criteria. These include having a serious brain injury before age 3, significant challenges in thinking and movement, and specific scores on tests that measure motor function and independence. Participants in the trial can expect to be part of a structured rehabilitation program, with their progress monitored closely over the year. It’s important to note that children with certain progressive brain conditions or who are planning to move to another treatment facility may not be able to join the study. The trial is currently recruiting participants, and parental consent is required for children to take part.

Gender

ALL

Eligibility criteria

  • 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.

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Hyères, Var, France

Patients applied

0 patients applied

Trial Officials

Marie-Christine ROUSSEAU, MD

Principal Investigator

Polyhandicap adultes San Salvadour, APHP

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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