- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900830
Therapy Program for Academic Skills in Children With Intellectual Disability
Effect of a Physical and Occupational Therapy Program on Academic Skills in Egyptian Children With Intellectual Disability
Study Overview
Status
Intervention / Treatment
Detailed Description
This study hypothesis
- There are statistically significant differences between the mean scores of the children of the experimental group in the pre and post measurements on the academic skills scale for children with mental disabilities and its sub-components in favor of the post measurement.
- There are no statistically significant differences between the mean scores of the children of the experimental group in the post and follow-up measurements on the academic skills scale for children with mental disabilities and its sub-components.
RESEARCH QUESTION:
What is the effect of a physical and occupational therapy program in improving academic skills (reading - writing - arithmetic) in a sample of children with mild intellectual disabilities? The study should include 20 children diagnosed with mild intellectual disability according to Stanford Binet scale 5th edition between the age of 8 to 10 years old from both sexes recruited from Noor Al-Sabah Association for the Care and Rehabilitation of People with Intellectual Disabilities from children with mild mental disabilities
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al Qahirah
-
Cairo, Al Qahirah, Egypt, 11411
- Tayseer Younes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The child should be between 8 and 10 years of age of both sexes
- The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition
- The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine
- The child should not suffer from any visual or auditory disorder
Exclusion Criteria:
- Children out of age range
- Children with moderate or severe intellectual disabilities
- Children with physical deformities in upper limb, lower limb or spine
- Children suffering from visual or auditory disorders
- Children of parents who refuse to sign the consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: common educational methods
this group will receive common educational methods
|
the child will receive his education in a passive manner
Other Names:
|
|
Experimental: play based program
this group will get the combined selected physical and occupational therapy program
|
A combined program based on physical and occupational therapy techniques within a play context
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Academic Skills Scale for Children with Mild Intellectual Disabilities.
Time Frame: 2 months
|
Reading and writing words, reading and writing simple sentences, knowledge of reading phenomena, comprehension., Reading, reading expression, reading and writing numbers and numbers, order and sequence, classification, relationships, arithmetic operations
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Stanford-Binet Scale, the fifth edition
Time Frame: 2 months
|
the Stanford-Binet Intelligence Scale Fifth Edition
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zienab M Mahmoud, PhD, Beni-Suef University
- Study Chair: Nahed MG Makary, PhD, Beni-Suef University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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