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

Study Overview
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Brief Summary
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: 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
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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.

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

Conditions
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Autistic Spectrum Disorder

Intervention / Treatment
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* Other: therapeutic diet.
* Other: physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>15 autistic child will receive gluten and casein free diet. | Other: therapeutic diet.<br>* gluten and casein free diet.<br>|
| Experimental: Group B<br>15 autistic child will receive physical therapy program. | Other: physiotherapy<br>* specific physiotherapy developmental program according to the pre evaluation of gross motor status.<br>|
| Experimental: Group C<br>15 autistic child will receive combination of gluten and casein free diet with physical therapy program. | Other: therapeutic diet.<br>* gluten and casein free diet.<br>Other: physiotherapy<br>* specific physiotherapy developmental program according to the pre evaluation of gross motor status.<br>|
| No Intervention: Group D<br>the group of no intervention as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gross motor development | Bruininks-oseretsky test of motor proficiency-1 | 2 hours | 
| Cognitive function | using Bimet IQ test | 2 hours |