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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00800-39 | Registry Identifier | IDRCB |
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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.
As secondary objectives, the study aims to:
compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:
evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
study the concordance between the Vineland scale and the Brunet-Lézine scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | patients will receive intensive care of rehabilitation of psychomotor |
|
| Control group | Active Comparator | patients will receive standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intentive rehabilitation | Behavioral | Intervention included:
during 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of adaptative behaviour | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of adaptative behaviour | Vineland II Scale will be used to evaluate the evolution of adaptative behaviour. | At 6 months |
| Evolution of development | Brunet-Lézine Scale will be used to evaluate the evolution of development. |
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Inclusion Criteria:
Children between 4 and 13 years;
With polyhandicap defined by association of the 5 following criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Christine ROUSSEAU, MD | Contact | +33 (4) 94 38 08 17 | marie-Christine.rousseau@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Christine ROUSSEAU, MD | Polyhandicap adultes San Salvadour, APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital San Salvadour | Recruiting | Hyères | Var | 83407 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11743709 | Background | 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. | |
| 20526405 | Background | Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. |
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| Routine care | Behavioral | Intervention included:
|
|
| At 12 months |
| Pain evaluation | Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain. | At 12 months |
| Durability of acquired cognitive-motor abilities | Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities. | at 18 months |
| Durability of acquired cognitive-motor abilities | The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities. | at 18 months |
| Quality of family's life surveys | WHOQOL-Bref questionnaire will be used. | At baseline and 12 months |
| Emotional distress measurement | Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents. | At baseline and 12 months |
| Burden surveys | Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents. | At baseline and 12 months |
| Clinical Global Impressions by caregivers | Clinical Global Impressions (CGI) Scale will be used by caregivers. | At baseline and 12 months |
| Quality of caregivers' life | The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers. | At baseline and 12 months |
| 31392551 | Background | 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. |