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

University of Jazan

Status: Completed

Conditions: Autistic Spectrum Disorder

Treatments: Other: therapeutic diet.; Other: physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06086964

HAPO-10-Z-001

Details and patient eligibility

About

: 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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Group A

Experimental group

Description:

15 autistic child will receive gluten and casein free diet.

Treatment:

Other: therapeutic diet.

Group B

Experimental group

Description:

15 autistic child will receive physical therapy program.

Treatment:

Other: physiotherapy

Group C

Experimental group

Description:

15 autistic child will receive combination of gluten and casein free diet with physical therapy program.

Treatment:

Other: physiotherapy

Other: therapeutic diet.

Group D

No Intervention group

Description:

the group of no intervention as a control group.