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临床试验/NCT04362800
NCT04362800已完成不适用

Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive MOtrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy: a Trial Multicentre Randomized Control With Medico-economic Evaluation

University Hospital, Brest4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
Gross Motor Function Measure (GMFM)

研究概览

简要总结

One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.

详细描述

The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
12 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child with bilateral cerebral palsy proven to be spastic or dyskinetic
  • 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
  • Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
  • Signature of consent by the two holders of parental authority

排除标准

  • Exceed 4 years and 11 months (59 months) during the internship evaluation period.
  • Uncontrolled epilepsy.
  • History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
  • Visual or cognitive deficit preventing the child from seeing the games and interacting
  • Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.

研究组 & 干预措施

Interventional

Experimental

10 days of intensive and structured motor therapy, 5 hours a day = 50h

干预措施: MRI (Other)

Interventional

Experimental

10 days of intensive and structured motor therapy, 5 hours a day = 50h

干预措施: Electro-Encephalography-High Density (Other)

Interventional

Experimental

10 days of intensive and structured motor therapy, 5 hours a day = 50h

干预措施: 3D and EMG analysis (Other)

Interventional

Experimental

10 days of intensive and structured motor therapy, 5 hours a day = 50h

干预措施: care and classic activities (Other)

Control

Placebo Comparator

10 days of care and classic activities

干预措施: MRI (Other)

Control

Placebo Comparator

10 days of care and classic activities

干预措施: Electro-Encephalography-High Density (Other)

Control

Placebo Comparator

10 days of care and classic activities

干预措施: 3D and EMG analysis (Other)

Control

Placebo Comparator

10 days of care and classic activities

干预措施: care and classic activities (Other)

结局指标

主要结局

Gross Motor Function Measure (GMFM)

时间窗: 1 hour

Measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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