Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap (REEDUC-PLH)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Polyhandicap

Treatments: Behavioral: Intentive rehabilitation; Behavioral: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT04280458

APHP200866

2020-A00800-39 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

As secondary objectives, the study aims to:

1. compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:

   • result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;
   • result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;
   • the pain evaluation at 12 months after randomization;
   • the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);
   • the quality of life of the patients' family or relatives at 12 months after randomization;
   • the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.

2. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.

3. study the concordance between the Vineland scale and the Brunet-Lézine scale.

Enrollment: 62 estimated patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

Intervention group

Experimental group

Description:

patients will receive intensive care of rehabilitation of psychomotor

Treatment:

Behavioral: Intentive rehabilitation

Control group

Active Comparator group

Description:

patients will receive standard care

Treatment:

Behavioral: Routine care