跳至主要内容
临床试验/NCT05123066
NCT05123066已完成不适用

Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月1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
40
试验地点
2
主要终点
Pediatric Quality of life Inventory Scale

研究概览

简要总结

Clinically, infants with Autism Spectrum Disorder often display gross motor delays in supine, prone, and sitting skills in their first year of life . Studies reveal that motor abnormalities in Autism Spectrum Disorder can occur very early in developmental trajectory.

详细描述

Hydrotherapy is an environment that may be conducive to encouraging physical activity in children with Autism Spectrum Disorder. The buoyancy of water can assist with movement, balance, and coordination .Water also provides an opportunity for social interaction through aquatic games and activities.Based on the literature, Aquatic therapy appears to be particularly beneficial for children with Autism Spectrum Disorder who need strong sensory stimulation.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

They will be allocated randomly into two groups of equal numbers, group I (the aquatic training group) and the group II (land exercises).

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age ranges from 3 to 5 years.
  • Mild to moderate autistic features according to GARS (scores from 60 to 110).

排除标准

  • Significant visual or auditory defects.
  • History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
  • Open wound.
  • Dermatological diseases

结局指标

主要结局

Pediatric Quality of life Inventory Scale

时间窗: Treatment for 3 monthes

Pediatric Quality of life Inventory Scale: The Arabic version will be used to assess quality of life. It contains questions about child's physical, emotional, social, and school functioning in the past 7 days. Parents/ child self-administered the quality of life after introductory instructions from the administrator. On the quality of life Generic Core Scales, for ease of interpretability, items are 22 reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related quality of Life. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0-100, 1=75, 2= 50, 3= 25 and 4= 0. Finally, the Scale Score for each dimension and Total Scale Score were calculated

Autism Index

时间窗: Treatment for 3 monthes

Gilliam autism rating scale: Items on the developmental subscale address behaviors and milestones in the first 36 months of life. Items on the first three behavioral subscales are rated on a four point like scale ranging from Never Observed (0) to Frequently Observed (3). After completing it, the examiner calculated the total raw scores then converted into scaled scores and percentile ranks according to the examiner's manual. Higher scaled scores on a subscale represent severe autistic behavior. Finally, the total scaled scores were calculated to measure the autism index according to the examiner's manual. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior

Motor Development

时间窗: Treatment for 3 monthes

The Peabody Developmental Motor Scales-Second Edition: The gross motor function domain will be assessed in the current study. The gross motor function domains contain four subtests. Reflexes, Stationary ,Locomotion and Object Manipulation . Grading and Scoring of the PDMS-2 The therapist will ask the child to do a specific item and observes how the child is doing the task. Items are scored as 2, 1 or 0. 0 = child cannot or will not attempt an item or the attempt does not indicate that the specific skill is emerging 1. = child's performance shows a clear resemblance to item mastery criteria but does not fully meet the criteria or there are signs of an emerging skill 2. = child performs item according to the criteria specified for mastering the skill

次要结局

未报告次要终点

研究者

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

Amira Mahmoud Abd-elmonem

Assist Prof. physical therapy for pediatric department, faculty of physical therappy

Cairo University

研究点 (2)

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