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临床试验/NCT02720432
NCT02720432已完成不适用

Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial

University Ghent2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in the score of the Hand assessment for infants (HAI)

研究概览

简要总结

This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.

详细描述

Perinatal stroke constitutes an acute presentation of encephalopathy; manifesting as seizure, altered mental status, and/or neurological deficit; between birth and the twenty-eight postnatal day for which a pattern of ischemic brain injury in an arterial distribution is evident by neuroimaging. Following perinatal stroke, approximately 60% of children develop cerebral palsy (usually presenting as spastic hemiplegia), 30-60% experience epilepsy, 25% show language delay, and up to 22% manifest behavioral problems.

The current most predictive tools for early diagnosis of CP are a combination of brain MRI/cUS and a general movements (GM) assessment in the fidgety period (9). Asymmetry of fidgety GMs around 12 weeks post term can be the first clinical signs of hemiplegia.

There are currently two intensive therapy approaches aiming at improving upper limb performance in adults and children (average age 8 years) with established hemiplegic CP: constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT). Those current therapy approaches fundamentally comprise repeated practice of desired movements based on motor learning principles with the adult/ child as an active participant.

Both therapies, in adults and in children with established hemiplegic CP (average age 8 years) are effective and show similar improvements if the dosage of therapy is similar. In contrast, the feasibility and the effects of both therapy approaches at very young age (under age 1 year) is still unknown (22). Exploring these options to treat even before asymmetric hand use has appeared is interesting and promising enough since recent animal studies have demonstrated that there is a critical period of motor system plasticity, and that activity-dependent reorganization of the motor-projection pattern to the hand occurs before about 1 year of age

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Months 至 8 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part.

排除标准

  • Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.

结局指标

主要结局

Change in the score of the Hand assessment for infants (HAI)

时间窗: before (around 4 months) and after 18 weeks of intervention (around 9 months)

The HAI is the very new assessment tool to evaluate the hand function and asymmetry in infants age from 2 till 8 months post term.

Change in the score of the Infant motor profile

时间窗: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

The IMP is a video-based assessment to evaluate the spontaneous motor behavior of infants from 3 months till independent walking around 18 months of age

Change in the score of the Alberta infant motor scale

时间窗: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.

次要结局

  • Bayley scales for infant development-third edition(between 22 and 24 months (2 years))
  • Parental sense of competence scale(before intervention (around 4months))
  • Questionnaire satisfaction and impact(after the intervention (around 9 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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