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

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

Study Overview

• Status: Completed
• Conditions: Autistic Spectrum Disorder
• Intervention / Treatment: Other: therapeutic diet.; Other: physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Gizan
    • Jazan, Gizan, Saudi Arabia, 45142
      • Jazan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Jazan

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: HAPO-10-Z-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: after finishing we can share the data with request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No