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

Sponsor

University of Jazan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06086964

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Spectrum Disorder	Other: therapeutic diet. Other: physiotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 17, 2023

Anticipated Primary Completion Date :

Feb 16, 2024

Anticipated Study Completion Date :

Mar 16, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

gross motor development [2 hours]
Bruininks-oseretsky test of motor proficiency-1
Cognitive function [2 hours]
using Bimet IQ test

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 15 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Jazan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Moustafa Mohamed Ahmed, assistant professor of basic science, physical therapy department, University of Jazan

ClinicalTrials.gov Identifier:

NCT06086964

Other Study ID Numbers:

HAPO-10-Z-001

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Study Results

No Results Posted as of Oct 23, 2023