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Completed

NCT Number: NCT06086964

Effect of Therapeutic Diet With Physiotherapy on Gross Motor and Cognition of Autistic Children

: 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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children diagnosed with autism spectrum disorders.
  • GMFCs 4

Exclusion criteria

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

Treatment and study plan

therapeutic diet.

Other

gluten and casein free diet.

Physiotherapy

Other

specific physiotherapy developmental program according to the pre evaluation of gross motor status.

Primary outcomes

  1. gross motor development

    Time frame: 2 hours

    Bruininks-oseretsky test of motor proficiency-1

  2. Cognitive function

    Time frame: 2 hours

    using Bimet IQ test

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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