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临床试验/NCT06864767
NCT06864767已完成不适用

Impact of Motor and Oral Motor Function on Quality of Life in Children With Type I Spinal Muscular Atrophy

Zeynep HOŞBAY1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Neuro-sensory Motor Developmental Assessment

研究概览

简要总结

The aim of this study is to investigate the impact of motor and oral motor functions on the quality of life in children aged 2-4 years diagnosed with Spinal Muscular Atrophy (SMA) Type I. In the study, the Neuro-Sensory-Motor Developmental Assessment (NSMDA) was used to evaluate motor functions, the Functional Oral Intake Scale (FOIS) to assess oral motor function, the Behavioral Pediatric Feeding Assessment Scale (BPFAS) to evaluate children's attitudes towards feeding, and the Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module to assess quality of life.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 4 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with Spinal Muscular Atrophy Type I
  • •Being between the ages of 2-4
  • •Families volunteering to participate in the study

排除标准

  • •Accompanied by another chronic disease other than SMA
  • •The mother or father has a cognitive problem that prevents them from expressing themselves
  • •The mother or father is illiterate

结局指标

主要结局

Neuro-sensory Motor Developmental Assessment

时间窗: Once, beginning of the study

The test used to assess children's development levels evaluates the child's development in six parameters: gross motor function, fine motor function, neurological status, infant movement patterns, postural development and sensory-motor function (tactile, proprioceptive, ocular and vestibular systems) on a scale of 1 to 5. High scores are interpreted as motor dysfunction.

Functional Oral Intake Scale

时间窗: Once, beginning of the study

It is a scale consisting of a total of 7 levels and two sections, developed by Crary et al. to indicate the functional oral intake of patients with dysphagia. A higher score indicates a better nutritional level.

Behavioral Pediatrics Feeding Assessment Scale

时间窗: Once, beginning of the study

The scale used to determine eating problems in children evaluates both the child's nutritional status and the parents' feelings about the child's nutritional status. It consists of 35 items in total and is scored from 1 to 5. High scores indicate problematic eating behaviors and habits.

次要结局

  • Pediatric Quality of Life Inventory(Once, beginning of the study)

研究者

发起方
Zeynep HOŞBAY
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeynep HOŞBAY

Prof

Biruni University

研究点 (1)

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