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

Autistic Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06086964
• Other study ID #: HAPO-10-Z-001
• Status: Completed
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 12, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Spectrum Disorder

Intervention

Other:
• therapeutic diet.
gluten and casein free diet.
• physiotherapy
specific physiotherapy developmental program according to the pre evaluation of gross motor status.

Locations

Country	Name	City	State
Saudi Arabia	Jazan University	Jazan	Gizan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gross motor development	Bruininks-oseretsky test of motor proficiency-1	2 hours
Primary	Cognitive function	using Bimet IQ test	2 hours