Intensive rehabilitation for children with polyhandicap
Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 4 Years to 13 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Hyères, Var) |
| Trial ID | NCT04280458 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 13 years with polyhandicap characterized by severe cognitive and motor impairments.
Not a fit: Patients with progressive encephalopathies or those who may have difficulty following up in the study will not benefit.
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 performed: While this approach is innovative, similar studies have shown promise in improving rehabilitation outcomes for children with complex disabilities.
Eligibility criteria
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 this trial is running
Hyères, Var
- Hôpital San Salvadour — Hyères, Var, France (Recruiting)
Study contacts
- Principal investigator: Marie-Christine ROUSSEAU, MD — Polyhandicap adultes San Salvadour, APHP
- Study coordinator: Marie-Christine ROUSSEAU, MD
- Email: marie-Christine.rousseau@aphp.fr
- Phone: +33 (4) 94 38 08 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.