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临床试验/NCT04754178
NCT04754178Unknown不适用

Assessment of Skills and Behaviors in Children With Down Syndrome

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
COMFORT behaviour scale

研究概览

简要总结

Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers rather than fathers. For this reason, in this study we aims to evaluate skills and behaviors in children with Down syndrome through the perception of parents.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Down syndrome childrens
  • Age between 0 and 3 years

排除标准

  • Other physical or functional impairment that limits the performance of evaluation

结局指标

主要结局

COMFORT behaviour scale

时间窗: Baseline

The COMFORT behaviour scale (COMFORT-B scale) is widely used in paediatric intensive care units to assess young children's pain and distress.

Feeding Hándicap Índex Children

时间窗: Baseline

y the Feeding Handicap Index (FHI), \[20\] was developed and standardized on typically developing children, children with CP, Autism spectrum disorder in the age range of 2-10 years and Intellectual disability. FHI has 38 items related to statements related to physical (21), emotional (12) and functional (5) aspects of feeding and swallowing abilities. It has a 3 point rating scale (0, 1 \& 2) where "0" indicates the individual "Never has this problem", "1" indicates "Sometimes has this problem" and "3" indicates "Always has this problem"

Parent Perceptions of Physical Activity Scale

时间窗: Baseline

Evaluate the Parent Perceptions of Physical Activity in Families of Toddlers With Neurodevelopmental Disorders

Bayley Scales of Infant and Toddler Development

时间窗: Baseline

is an individually administered scale that assesses five key developmental domains in children between 1-42 months of age: cognition, language (receptive and expressive communication), motor (gross and fine), social-emotional and adaptive behavior. The first three are assessed through direct observation of the child in test situations, while the last two are assessed through questionnaires to be completed by the main caregiver.

Infant Positioning Assessment Tool

时间窗: Baseline

The Infant Position AssessmentTool (IPAT) is a six-item tool with cumulative scores ranging from 0 to 12. It was developed as a teaching tool to standardize developmentally supportive positioning practices in the NICU and provides a method for evaluation of those positioning practices.

Asymmetry

时间窗: Baseline

Asymmetry was evaluated with photography

Montreal's children's Hospital Feeding Scale

时间窗: Baseline

The Montreal Children's Hospital Feeding Scale (MCHFS) is a quick and reliable measure of feeding problems for clinical settings, but there is little examination of its relationship to commonly used research measures of parental feeding practice, child eating behaviour and observations of parent-infant interaction at mealtimes.

Early Clinical Assessment of Balance

时间窗: Baseline

The Early Clinical Assessment of Balance (ECAB) is a measure of postural stability for children.

Segmental Assessment of Trunk Control

时间窗: Baseline

The SATCo i,ii is a validated outcome measure that identifies at which head/trunk segment Targeted Training should commence. The SATCo determines the topmost (most cephalo) segment at which control of the upright posture is poor or not demonstrated i.e. is currently being learned for each of static, active and reactive control.

Early Motor Questionnaire

时间窗: Baseline

The EMQ is designed as a fast and easy to complete motor questionnaire, and is organized into 3 sections: Gross motor skills, fine motor skills, and perception-action integration skills. The EMQ is not a standardized assessment, but can be used in research settings, serve as a motor screener, or as complement to standardized measures of early motor development.

次要结局

  • Charlson comorbidity index(Baseline)
  • Brief Infant Sleep Questionnaire(Baseline)
  • EuroQol-5D(Baseline)
  • International physical activity questionnaire(Baseline)
  • Hospital Anxiety and Depression Scale(Baseline)
  • Zarit Burden Interview(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

研究点 (1)

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