Effect of Therapeutic Diet With Physiotherapy on Gross Motor and Cognition of Autistic Children
NCT ID: NCT06086964
Last Updated: 2024-03-15
Study Results
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2023-10-17
2024-03-12
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A
15 autistic child will receive gluten and casein free diet.
therapeutic diet.
gluten and casein free diet.
Group B
15 autistic child will receive physical therapy program.
physiotherapy
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.
therapeutic diet.
gluten and casein free diet.
physiotherapy
specific physiotherapy developmental program according to the pre evaluation of gross motor status.
Group D
the group of no intervention as a control group.
No interventions assigned to this group
Interventions
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therapeutic diet.
gluten and casein free diet.
physiotherapy
specific physiotherapy developmental program according to the pre evaluation of gross motor status.
Eligibility Criteria
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Inclusion Criteria
* GMFCs 4
Exclusion Criteria
* autistic children with any bulbar affection lead to problem in swallowing.
3 Years
15 Years
ALL
No
Sponsors
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University of Jazan
OTHER_GOV
Responsible Party
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Mohamed Moustafa Mohamed Ahmed
assistant professor of basic science, physical therapy department
Locations
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Jazan University
Jizan, Gizan, Saudi Arabia
Countries
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Other Identifiers
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HAPO-10-Z-001
Identifier Type: -
Identifier Source: org_study_id
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