NCT04851600尚未招募不适用
Adaptative Motor Behavior of Children With Unilateral Upper Limb Deficiency After Early Prosthetics.
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
研究概览
简要总结
For children with congenital upper limb deficiency, introduction of the prosthesis is guided by clinical experience rather than by Evidence Based Medicine.
This study will assess early development in children with upper limb deficiency according to age at the introduction of the prosthesis.
This study will give new keys in these specific prosthesis cares.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female child
- •Aged from 1 month to 3 months and a half
- •Placement of a prosthesis in a patient with isolated upper limb deficiency, type of congenital transverse unilateral amputation of the forearm segment
- •Socially insured patient,
- •Patient willing to comply with all study procedures and study duration
- •Written informed consent from patient's legal guardians
排除标准
- •Children with one or more high risk factors for neurodevelopmental disorders:
- •Very prematurity (<32 weeks of amenorrhea [SA])
- •Premature infants <37 WA with intrauterine growth retardation (IUGR) or low weight for gestational age (PAG) <3rd percentile or <- 2 SD for GA and sex according to national reference curves)
- •A presumed hypoxo-ischemic encephalopathy with an indication of therapeutic hypothermia
- •A perinatal arterial cerebrovascular accident (AVC) (diagnosed between the 20th week of fetal life and the 28th day of life including in premature newborns).
- •Cerebral growth anomalies: microcephaly with cranial perimeter <- 2 SD at birth verified secondarily or macrocephaly> + 3 SD for the term (persisting after a second measurement).
- •A family history of severe first-degree neurodevelopmental disorder (brother or sister or parent)
- •Symptomatic congenital cytomegalovirus infections and other infectious fetopathies: toxoplasmosis, Zika, rubella, etc.
- •Bacterial and viral herpetic meningoencephalitis
- •Complex congenital heart disease operated on: transposition of the large vessels; left ventricular hypoplastic syndrome.
- •Perinatal exposure to a major toxicant: certain antiepileptics (sodium valproate); severe exposure to alcohol and / or with signs of fetal disease.
- •Major, prolonged and repeated surgery (cardiac, cerebral, abdominal, thoracic).
- •Exclusion of all deficiency forming part of a polymalformative, vascular syndrome (Poland syndrome), genetic cause ...
- •Exclusion of all other forms of agenesis (bilateral, longitudinal, persistence of hand remains),
- •Refusal of consent from one or both parents
结局指标
主要结局
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
时间窗: at 24 months old
次要结局
- Communication Domain Score(at 9 months old , at 24 months old)
- Assisting Hand Assessment(at 3 years old)
- Daily living skills Domain Score at 9 and 24 months old(at 9 months old , at 24 months old, at 3 years old)
- Motor skills Domain score(at 9 months old)
- Socialization Domain score(at 9 months old , at 24 months old, at 3 years old)
研究者
研究点 (1)
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