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

Not Applicable

Recruiting

• Conditions: Polyhandicap
• Interventions: Behavioral: Routine care; Behavioral: Intentive rehabilitation

• Registration Number: NCT04280458
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Study Start: 2022-06-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Routine care	patients will receive standard care
Intervention group	Intentive rehabilitation	patients will receive intensive care of rehabilitation of psychomotor

Primary Outcome Measures

Name	Time	Method
Evolution of adaptative behaviour	At 12 months	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

Secondary Outcome Measures

Name	Time	Method
Evolution of adaptative behaviour	At 6 months	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Evolution of development	At 12 months	Brunet-Lézine Scale will be used to evaluate the evolution of development.
Pain evaluation	At 12 months	Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
Burden surveys	At baseline and 12 months	Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.
Clinical Global Impressions by caregivers	At baseline and 12 months	Clinical Global Impressions (CGI) Scale will be used by caregivers.
Durability of acquired cognitive-motor abilities	at 18 months	The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.
Quality of family's life surveys	At baseline and 12 months	WHOQOL-Bref questionnaire will be used.
Quality of caregivers' life	At baseline and 12 months	The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.
Emotional distress measurement	At baseline and 12 months	Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents.

Trial Locations

Locations (1)

Hôpital San Salvadour; 🇫🇷 Hyères, Var, France