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

NCT ID: NCT06086964

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2024-03-12

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.

Conditions

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Autistic Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

15 autistic child will receive gluten and casein free diet.

Group Type EXPERIMENTAL

therapeutic diet.

Intervention Type OTHER

gluten and casein free diet.

Group B

15 autistic child will receive physical therapy program.

Group Type EXPERIMENTAL

physiotherapy

Intervention Type OTHER

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

Group C

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

Group Type EXPERIMENTAL

therapeutic diet.

Intervention Type OTHER

gluten and casein free diet.

physiotherapy

Intervention Type OTHER

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

Group D

the group of no intervention as a control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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therapeutic diet.

gluten and casein free diet.

Intervention Type OTHER

physiotherapy

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

Intervention Type OTHER

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jazan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohamed Moustafa Mohamed Ahmed

assistant professor of basic science, physical therapy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jazan University

Jizan, Gizan, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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HAPO-10-Z-001

Identifier Type: -

Identifier Source: org_study_id

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