NCT04280458招募中不适用
Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Evolution of adaptative behaviour
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Experimental
patients will receive intensive care of rehabilitation of psychomotor
干预措施: Intentive rehabilitation (Behavioral)
Control group
Active Comparator
patients will receive standard care
干预措施: Routine care (Behavioral)
结局指标
主要结局
Evolution of adaptative behaviour
时间窗: At 12 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
次要结局
- Evolution of adaptative behaviour(At 6 months)
- Evolution of development(At 12 months)
- Pain evaluation(At 12 months)
- Quality of family's life surveys(At baseline and 12 months)
- Burden surveys(At baseline and 12 months)
- Clinical Global Impressions by caregivers(At baseline and 12 months)
- Quality of caregivers' life(At baseline and 12 months)
- Emotional distress measurement(At baseline and 12 months)
- Durability of acquired cognitive-motor abilities(at 18 months)
研究者
研究点 (2)
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