Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intentive rehabilitation, Routine care.
- Who it may be relevant to
- Registry conditions: Polyhandicap. Basic parameters: 4 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
Overview
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.
Interventions
- Behavioral Intentive rehabilitation
Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months. - Behavioral Routine care
Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.
Primary outcome measures
- Evolution of adaptative behaviour [Time frame: At 12 months]
Secondary outcome measures (10)
- Evolution of adaptative behaviour [Time frame: At 6 months]
- Evolution of development [Time frame: At 12 months]
- Pain evaluation [Time frame: At 12 months]
- Durability of acquired cognitive-motor abilities [Time frame: at 18 months]
- Durability of acquired cognitive-motor abilities [Time frame: at 18 months]
- Quality of family's life surveys [Time frame: At baseline and 12 months]
- Emotional distress measurement [Time frame: At baseline and 12 months]
- Burden surveys [Time frame: At baseline and 12 months]
- Clinical Global Impressions by caregivers [Time frame: At baseline and 12 months]
- Quality of caregivers' life [Time frame: At baseline and 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital San Salvadour — Hyères
Publications
- 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. PMID 11743709
- Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. PMID 20526405
- 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. PMID 31392551
Identifiers
NCT: NCT04280458 · APHP200866 · 2020-A00800-39