Intellectual Disability, MildNCT05900830
Therapy Program for Academic Skills in Children With Intellectual Disability
A study testing play therapy and common educational methods in people with Intellectual Disability, Mild and Educational Problems, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Intellectual Disability, Mild, Educational Problems
- What is being tested?
- play therapy and common educational methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Physical and Occupational Therapy Program on Academic Skills in Egyptian Children With Intellectual Disability
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
Read the 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
- Being tested
- play therapy, common educational methods
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
play therapyOther
Also called physical and occupational therapy program
A combined program based on physical and occupational therapy techniques within a play context
common educational methodsOther
Also called Passive class room education
the child will receive his education in a passive manner
| Study group | Role | What they receive |
|---|---|---|
| common educational methods | Active comparator | this group will receive common educational methods Receives: Other: common educational methods |
| play based program | Experimental | this group will get the combined selected physical and occupational therapy program Receives: Other: play therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (1)
The Stanford-Binet Scale, the fifth edition
the Stanford-Binet Intelligence Scale Fifth Edition
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start15 Nov 2022
- Primary completion30 Jan 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disability, MildStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi experimental
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayseer Saber Abdeldayem, Beni-Suef University
- Investigators
- Zienab M Mahmoud, PhD, Study chair, Beni-Suef UniversityNahed MG Makary, PhD, Study chair, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900830
- Sponsor's protocol ID
- P.T.REC/012/004233
- Status last verified
- Nov 2024
- First submitted
- 10 Feb 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no personal data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physical and Occupational Therapy Program on Academic Skills in Egyptian Children With Intellectual Disability
- ClinicalTrials.gov ID
- NCT05900830
- Acronym / sponsor ID
- P.T.REC/012/004233
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi experimental
| Arm | Type | Receives |
|---|---|---|
| common educational methods | Active comparator | Other: common educational methodsthis group will receive common educational methods |
| play based program | Experimental | Other: play therapythis group will get the combined selected physical and occupational therapy program |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| play therapyAlso: physical and occupational therapy programA combined program based on physical and occupational therapy techniques within a play context | Other | play based program |
| common educational methodsAlso: Passive class room educationthe child will receive his education in a passive manner | Other | common educational methods |
Primary outcome
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
1 secondary outcome
The Stanford-Binet Scale, the fifth edition
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. no personal data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zienab M Mahmoud, PhD study chair
Beni-Suef University
Nahed MG Makary, PhD study chair
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing play therapy and common educational methods in people with Intellectual Disability, Mild and Educational Problems, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Academic Skills Scale for Children with Mild Intellectual Disabilities. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.