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Clinical Trials/NCT06086964
NCT06086964
Completed
Not Applicable

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

University of Jazan1 site in 1 country80 target enrollmentOctober 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autistic Spectrum Disorder
Sponsor
University of Jazan
Enrollment
80
Locations
1
Primary Endpoint
Cognitive function
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

: 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2023
End Date
March 12, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jazan
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Moustafa Mohamed Ahmed

assistant professor of basic science, physical therapy department

University of Jazan

Eligibility Criteria

Inclusion Criteria

  • Children diagnosed with autism spectrum disorders.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cognitive function

Time Frame: 2 hours

using Bimet IQ test

gross motor development

Time Frame: 2 hours

Bruininks-oseretsky test of motor proficiency-1

Study Sites (1)

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