Clinical trial Recruiting at 1 site Interventional Ages 4 to 13

Intensive rehabilitation for children with polyhandicap

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

Run by Assistance Publique - Hôpitaux de Paris · NCT04280458 · Data updated 2026-11-12

This study tests if intensive rehabilitation helps children with multiple disabilities improve their daily skills and overall quality of life better than regular care.

Quick facts

Study typeInterventional
Ages4 Years to 13 Years
SexAll
Enrollment62 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Hyères, Var)
StatusRecruiting
StartedJune 20, 2022
Main results expectedJanuary 2026
Study endsJanuary 2026
Registry record updatedMarch 19, 2025
Trial IDNCT04280458 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 4 to 13 years with polyhandicap characterized by severe cognitive and motor impairments.

Probably not a fit

Patients with progressive encephalopathies or those who may have difficulty following up in the study will not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effects of intensive psychomotor rehabilitation against standard care on the adaptive behavior of children with polyhandicap over a 12-month period. It evaluates various outcomes, including adaptive behavior, cognitive-motor skills, pain levels, and quality of life for both patients and their families. The study also assesses the tolerance of the intensive rehabilitation approach and the correlation between different evaluation scales. The goal is to determine the effectiveness of intensive rehabilitation in improving the lives of affected children.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the adaptive capabilities and overall quality of life for children with polyhandicap.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving rehabilitation outcomes for children with complex disabilities.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hôpital San Salvadour
    Hyères, Var, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.