Therapy Program for Academic Skills in Children With Intellectual Disability

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05900830
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 7.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Intellectual Disability, Mild; Educational Problems	Other: play therapy; Other: common educational methods	N/A

Detailed Description

This study hypothesis

1. 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.

2. 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

1. The child should be between 8 and 10 years of age of both sexes

2. The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition

3. The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine

4. The child should not suffer from any visual or auditory disorder

Exclusive criteria

1. Children out of age range

2. Children with moderate or severe intellectual disabilities

3. Children with physical deformities in upper limb, lower limb or spine

4. Children suffering from visual or auditory disorders

5. Children of parents who refuse to sign the consent form

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Quasi experimentalQuasi experimental
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of a Physical and Occupational Therapy Program on Academic Skills in Egyptian Children With Intellectual Disability
• Actual Study Start Date: Nov 15, 2022
• Actual Primary Completion Date: Jan 30, 2023
• Actual Study Completion Date: Feb 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: common educational methods this group will receive common educational methods	Other: common educational methods; the child will receive his education in a passive manner; Other Names: Passive class room education
Experimental: play based program this group will get the combined selected physical and occupational therapy program	Other: play therapy; A combined program based on physical and occupational therapy techniques within a play context; Other Names: physical and occupational therapy program

Outcome Measures

Primary Outcome Measures

1. The Academic Skills Scale for Children with Mild Intellectual Disabilities. [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

Secondary Outcome Measures

1. The Stanford-Binet Scale, the fifth edition [2 months]

   the Stanford-Binet Intelligence Scale Fifth Edition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The child should be between 8 and 10 years of age of both sexes

2. The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition

3. The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine

4. The child should not suffer from any visual or auditory disorder

Exclusion Criteria:

1. Children out of age range

2. Children with moderate or severe intellectual disabilities

3. Children with physical deformities in upper limb, lower limb or spine

4. Children suffering from visual or auditory disorders

5. Children of parents who refuse to sign the consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tayseer Younes	Cairo	Al Qahirah	Egypt	11411

Sponsors and Collaborators

• Beni-Suef University

Investigators

• Study Chair: Zienab M Mahmoud, PhD, Beni-Suef University
• Study Chair: Nahed MG Makary, PhD, Beni-Suef University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherin Hassan Mohammed Mehani, Clinical Professor, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT05900830
• Other Study ID Numbers: P.T.REC/012/004233
• First Posted: Jun 13, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intellectual Disability

Study Results

No Results Posted as of Jun 13, 2023