跳至主要内容
临床试验/NCT06027645
NCT06027645招募中不适用

Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder

Marianne Barbu-Roth6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
6
主要终点
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.

研究概览

简要总结

Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.

The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay.

Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions.

These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.

Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.

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
39 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Term between 24-26 GA or 26-32 GA with suspected brain lesion
  • parental consent
  • family living in intervention area
  • good tolerance on the first crawliskate trial

排除标准

  • no bronchodysplasia defined by oxygen dependency after 36 GA
  • no medical disease
  • no limb deformity
  • no karyotype anomaly
  • no visual or auditory impairment

结局指标

主要结局

Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.

时间窗: 12 months corrected age

The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.

次要结局

  • 2D & 3D analysis of movement(at 39-42 gestational age, 2, 6, 9, 12 months corrected age)
  • Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.(2, 6, 9, 12, 24 months corrected age)
  • Prechtl assessment(at 39-42 gestational age and 2 months corrected age)
  • Amiel-Tison Neurological Assessment(at 39-42 gestational age, 2, 9, 12 months corrected age)
  • Age and Stage questionnaire (ASQ) 3(2, 6, 9, 12, 18, 28 corrected age and 5 years)

研究者

发起方
Marianne Barbu-Roth
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marianne Barbu-Roth

Principal Investigator

Centre National de la Recherche Scientifique, France

研究点 (6)

Loading locations...

相似试验