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

Primary Purpose

Autistic Spectrum Disorder

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

therapeutic diet.

physiotherapy

About this trial

This is an interventional supportive care trial for Autistic Spectrum Disorder

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Group C

Group D

Arm Description

15 autistic child will receive gluten and casein free diet.

15 autistic child will receive physical therapy program.

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

the group of no intervention as a control group.

Outcomes

Primary Outcome Measures

gross motor development

Bruininks-oseretsky test of motor proficiency-1

Cognitive function

using Bimet IQ test

Secondary Outcome Measures

Full Information

NCT ID

NCT06086964

First Posted

October 10, 2023

Last Updated

October 18, 2023

Sponsor

University of Jazan

1. Study Identification

Unique Protocol Identification Number

NCT06086964

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 17, 2023 (Anticipated)

Primary Completion Date

February 16, 2024 (Anticipated)

Study Completion Date

March 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jazan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autistic Spectrum Disorder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

15 autistic child will receive gluten and casein free diet.

Arm Title

Group B

Arm Type

Experimental

Arm Description

15 autistic child will receive physical therapy program.

Arm Title

Group C

Arm Type

Experimental

Arm Description

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

Arm Title

Group D

Arm Type

No Intervention

Arm Description

the group of no intervention as a control group.

Intervention Type

Other

Intervention Name(s)

therapeutic diet.

Intervention Description

gluten and casein free diet.

Intervention Type

Other

Intervention Name(s)

physiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

gross motor development

Description

Bruininks-oseretsky test of motor proficiency-1

Time Frame

2 hours

Title

Cognitive function

Description

using Bimet IQ test

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

after finishing we can share the data with request.

Learn more about this trial

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

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