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

NCT06086964 | Completed

• 1 other identifier: HAPO-10-Z-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• gross motor development

  Bruininks-oseretsky test of motor proficiency-1

  2 hours

• Cognitive function

  using Bimet IQ test

  2 hours

Study Arms (4)

Group A

EXPERIMENTAL

15 autistic child will receive gluten and casein free diet.

Other: therapeutic diet.

Group B

EXPERIMENTAL

15 autistic child will receive physical therapy program.

Other: physiotherapy

Group C

EXPERIMENTAL

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

Other: therapeutic diet.; Other: physiotherapy

Group D

NO INTERVENTION

the group of no intervention as a control group.

Interventions

therapeutic diet. OTHER

gluten and casein free diet.

Group A; Group C

physiotherapy OTHER

specific physiotherapy developmental program according to the pre evaluation of gross motor status.

Group B; Group C

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with autism spectrum disorders.
• GMFCs 4

You may not qualify if:

• autistic children with any musculoskeletal deformities.
• autistic children with any bulbar affection lead to problem in swallowing.

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of basic science, physical therapy department

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: October 17, 2023
• Primary Completion: February 16, 2024
• Study Completion: March 12, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)