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临床试验/NCT06086964
NCT06086964已完成不适用

Effect of Therapeutic Diet Along With Special Physiotherapy Program on Growth Motor Development and Cognitive Function in Autism Spectrum Children

University of Jazan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月17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
80
试验地点
2
主要终点
Cognitive function

研究概览

简要总结

: A clinical trial will be conducted to investigate the effect of free-gluten/ casein diet along with specific physiotherapy program on gross motor development and cognitive function in 3-12 years old children with ASD, And thus establish a streamlining of nutrition and physical activity for children with autism and ASD.

详细描述

Autism is a complex neurological and developmental disability that appears within early developmental stages of life. Autism affects the normal functioning of the brain, communication development as well as social skills of the child. Autism has been regarded as a life-long condition and it cannot be cured. However, severity may decrease through special diet and physiotherapy program.

In Saudi Arabia, the prevalence revealed that confirmed cases of ASD were 42,500, and many remained undiagnosed A target group of (60) children diagnosed with autism or ASD, attending the paediatric psychiatry outpatient clinic and autism centres will be enrolled in this clinical trial study, which will be conducted in Jazan City-Saudi Arabia.

The inclusion criteria will be as follows: (1) parental consent, (2) age 3-12 years, and (3) a diagnosis of autism or ASD. Exclusion criteria were as follows: (1) autism associated with a genetic syndrome, (2) patients with comorbidities (3) known food allergy leading to avoidance of certain foods, and (4) mother or primary caretaker not available to be adherent to the prescribed diet. Three groups will be designed: (1) autistic children with regular diet and physiotherapy program. (2) Autistic children on free gluten/casein diet and (3) Autistic children on free gluten/casein diet and subjected to specific physiotherapy program. The study will be continued for 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children diagnosed with autism spectrum disorders.

排除标准

  • autistic children with any musculoskeletal deformities.
  • autistic children with any bulbar affection lead to problem in swallowing.

结局指标

主要结局

Cognitive function

时间窗: 2 hours

using Bimet IQ test

gross motor development

时间窗: 2 hours

Bruininks-oseretsky test of motor proficiency-1

次要结局

未报告次要终点

研究者

发起方
University of Jazan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Moustafa Mohamed Ahmed

assistant professor of basic science, physical therapy department

University of Jazan

研究点 (2)

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