Clinical trial NCT04280458: Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Official title: Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polyhandicap
Keywords: children polyhandicap
rehabilitation
psychomotor
cognitive-motor
adaptative skill
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evolution of adaptative behaviour
timeFrame: At 12 months
Secondary outcomes:
measure: Evolution of adaptative behaviour
timeFrame: At 6 months
measure: Evolution of development
timeFrame: At 12 months
measure: Pain evaluation
timeFrame: At 12 months
measure: Durability of acquired cognitive-motor abilities
timeFrame: at 18 months
measure: Durability of acquired cognitive-motor abilities
timeFrame: at 18 months
measure: Quality of family's life surveys
timeFrame: At baseline and 12 months
measure: Emotional distress measurement
timeFrame: At baseline and 12 months
measure: Burden surveys
timeFrame: At baseline and 12 months
measure: Clinical Global Impressions by caregivers
timeFrame: At baseline and 12 months
measure: Quality of caregivers' life
timeFrame: At baseline and 12 months
Other outcomes:
Locations:
city: Hyères
country: France
facility: Hôpital San Salvadour
state: Var
Study officials:
affiliation: Polyhandicap adultes San Salvadour, APHP
name: Marie-Christine ROUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collignon P, Giusiano B. Validation of a pain evaluation scale for patients with severe cerebral palsy. Eur J Pain. 2001;5(4):433-42. doi: 10.1053/eujp.2001.0265.
citation: Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
citation: Laor-Maayany R, Goldzweig G, Hasson-Ohayon I, Bar-Sela G, Engler-Gross A, Braun M. Compassion fatigue among oncologists: the role of grief, sense of failure, and exposure to suffering and death. Support Care Cancer. 2020 Apr;28(4):2025-2031. doi: 10.1007/s00520-019-05009-3. Epub 2019 Aug 8.