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Therapy Program for Academic Skills in Children With Intellectual Disability

Primary Purpose

Intellectual Disability, Mild, Educational Problems

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
play therapy
common educational methods
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability, Mild

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tayseer Younes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

common educational methods

play based program

Arm Description

this group will receive common educational methods

this group will get the combined selected physical and occupational therapy program

Outcomes

Primary Outcome Measures

The Academic Skills Scale for Children with Mild Intellectual Disabilities.
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

Secondary Outcome Measures

The Stanford-Binet Scale, the fifth edition
the Stanford-Binet Intelligence Scale Fifth Edition

Full Information

First Posted
February 10, 2023
Last Updated
June 9, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05900830
Brief Title
Therapy Program for Academic Skills in Children With Intellectual Disability
Official Title
Effect of a Physical and Occupational Therapy Program on Academic Skills in Egyptian Children With Intellectual Disability
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effect of a physical and occupational therapy program on academic skills in a sample of Egyptian children with intellectual disability. It also aims to provide a program based on physical and occupational therapy activities and techniques to develop children's basic abilities through play to make learning more enjoyable
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 Inclusive 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 Exclusive 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Mild, Educational Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi experimental
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
common educational methods
Arm Type
Active Comparator
Arm Description
this group will receive common educational methods
Arm Title
play based program
Arm Type
Experimental
Arm Description
this group will get the combined selected physical and occupational therapy program
Intervention Type
Other
Intervention Name(s)
play therapy
Other Intervention Name(s)
physical and occupational therapy program
Intervention Description
A combined program based on physical and occupational therapy techniques within a play context
Intervention Type
Other
Intervention Name(s)
common educational methods
Other Intervention Name(s)
Passive class room education
Intervention Description
the child will receive his education in a passive manner
Primary Outcome Measure Information:
Title
The Academic Skills Scale for Children with Mild Intellectual Disabilities.
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The Stanford-Binet Scale, the fifth edition
Description
the Stanford-Binet Intelligence Scale Fifth Edition
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zienab M Mahmoud, PhD
Organizational Affiliation
Beni-Suef University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nahed MG Makary, PhD
Organizational Affiliation
Beni-Suef University
Official's Role
Study Chair
Facility Information:
Facility Name
Tayseer Younes
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11411
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no personal data will be shared

Learn more about this trial

Therapy Program for Academic Skills in Children With Intellectual Disability

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