Intellectual DisabilityNCT06735482
Therapeutic Play in Children With Mild Intellectual Disability
A study testing Therapeutic play program in people with Intellectual Disability and Intellectual Disability, Mild, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the effectiveness of a designed therapeutic play activities program on improving motor adaptive behavior in a sample of Egyptian children with mild intellectual disabilities. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Intellectual Disability, Intellectual Disability, Mild, Motor and Developmental Delay
- What is being tested?
- Therapeutic play program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Apr 2025
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child should be between 5 and 9 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Therapeutic Play Activities on Motor Adaptive Behavior in Egyptian Children With Mild Intellectual Disability
The aim of this study is to determine the effectiveness of a designed therapeutic play activities program on improving motor adaptive behavior in a sample of Egyptian children with mild intellectual disabilities. The main question it aims to answer is:
What is the effect of therapeutic play activities in improving adaptive motor skills (fine-gap) of children with mild intellectual disability? A quasi-experimental design will be used as researchers will compare therapeutic play exercise program to standard treatment to find its effect on motor adaptive behavior in the selected sample of children with mild intellectual disability
Read more
Participants will:
Take play-based activity program for 24 sessions in 2 months Have a pre- and post-intervention evaluation of motor adaptive behavior by Vineleand Adaptive Behavior Scale II
Read the detailed description
The research sample consists of twenty children whose ages range between 5 and 9 years of children with mild intellectual disabilities, with intelligence coefficients ranging between 50 and 70 on the Stanford Binet Scale, 5th edition (SB-5). The sample will be divided into two groups: 10 children in the control group and 10 children in the experimental group.
Methods For Intervention Experimental group Therapeutic Play Activities program for children with mild intellectual disability The validation of the current research hypotheses required the preparation and design of a program of therapeutic play activities aimed at improving the adaptive motor skills of children with intellectual disabilities. The program consists of 24 sessions of play-based activities that will be applied in 2 months on a day-by-day basis. Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. Activities will be simulated for the child by the therapist to ensure the child understands them. All children will be evaluated by VABSII before and after implementation of the program.
- Conditions
- Intellectual Disability, Intellectual Disability, Mild, Motor and Developmental Delay, Motor Delay, Adaptive Behavior, Physical Disability
- Being tested
- Therapeutic play program
- Keywords
- Play, Play therapy, Therapeutic play, Motor Adaptive Behavior, Adaptive Behavior, Intellectual Disability
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular, Learning Disabilities, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic play programBehavioural
Also called play therapy program
Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills.
| Study group | Role | What they receive |
|---|---|---|
| Group A Experimental | Experimental | Therapeutic Play Activities program for children with mild intellectual disability.
a program of therapeutic play activities aimed at improving the adaptive motor skills of children with intellectual disabilities. The program consists of 24 sessions of play-based activities that will be applied in 2 months on a day-by-day basis. Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. Activities will be simulated for the child by the therapist to ensure the child understands them. Receives: Behavioral: Therapeutic play program |
| Group B control | No intervention | Children will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stanford-Binet Scale, the fifth edition (SB-5)
The Stanford-Binet Scale, the fifth edition, aims to measure intelligence and cognitive abilities in humans, in the age range of (2-85 years).
Measured: 8 weeks
The Vineland Adaptive Behavior Scale: Second Edition (Vineland II)
The Vineland Adaptive Behavior Scale II measures an individual's development of personal independence and social responsibility by gathering information about day-to-day activities necessary to take care of oneself and to get along with others.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Dec 2024
- Primary completion30 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- 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
- Tayseer S Abdeldayem, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735482
- Sponsor's protocol ID
- FPTBSUREC/0903/241124
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Play Activities on Motor Adaptive Behavior in Egyptian Children With Mild Intellectual Disability
- ClinicalTrials.gov ID
- NCT06735482
- Acronym / sponsor ID
- FPTBSUREC/0903/241124
- Conditions
- Intellectual Disability, Intellectual Disability, Mild, Motor and Developmental Delay, Motor Delay, Adaptive Behavior, Physical Disability
- Keywords
- Play, Play therapy, Therapeutic play, Motor Adaptive Behavior, Adaptive Behavior, Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 16 Dec 2024 (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 determine the effectiveness of a designed therapeutic play activities program on improving motor adaptive behavior in a sample of Egyptian children with mild intellectual disabilities. The main question it aims to answer is:
What is the effect of therapeutic play activities in improving adaptive motor skills (fine-gap) of children with mild intellectual disability? A quasi-experimental design will be used as researchers will compare therapeutic play exercise program to standard treatment to find its effect on motor adaptive behavior in the selected sample of children with mild intellectual disability
Participants will:
Take play-based activity program for 24 sessions in 2 months Have a pre- and post-intervention evaluation of motor adaptive behavior by Vineleand Adaptive Behavior Scale II
Detailed description
The research sample consists of twenty children whose ages range between 5 and 9 years of children with mild intellectual disabilities, with intelligence coefficients ranging between 50 and 70 on the Stanford Binet Scale, 5th edition (SB-5). The sample will be divided into two groups: 10 children in the control group and 10 children in the experimental group.
Methods For Intervention Experimental group Therapeutic Play Activities program for children with mild intellectual disability The validation of the current research hypotheses required the preparation and design of a program of therapeutic play activities aimed at improving the adaptive motor skills of children with intellectual disabilities. The program consists of 24 sessions of play-based activities that will be applied in 2 months on a day-by-day basis. Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. Activities will be simulated for the child by the therapist to ensure the child understands them. All children will be evaluated by VABSII before and after implementation of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi experimental
| Arm | Type | Receives |
|---|---|---|
| Group A Experimental | Experimental | Behavioral: Therapeutic play programTherapeutic Play Activities program for children with mild intellectual disability. a program of therapeutic play activities aimed at improving the adaptive motor skills of children with intellectual disabilities. The program consists of 24 sessions of play-based activities that will be applied in 2 months on a day-by-day basis. Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. Activities will be simulated for the child by the therapist to ensure the child understands them. |
| Group B control | No intervention | –Children will not receive any intervention |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The child should be between 5 and 9 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 (1 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
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 |
|---|---|---|
| Therapeutic play programAlso: play therapy programTherapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. | Behavioural | Group A Experimental |
Primary outcome
The Stanford-Binet Scale, the fifth edition (SB-5)
Time frame: 8 weeks
The Stanford-Binet Scale, the fifth edition, aims to measure intelligence and cognitive abilities in humans, in the age range of (2-85 years).
The Vineland Adaptive Behavior Scale: Second Edition (Vineland II)
Time frame: 8 weeks
The Vineland Adaptive Behavior Scale II measures an individual's development of personal independence and social responsibility by gathering information about day-to-day activities necessary to take care of oneself and to get along with others.
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Tayseer S Abdeldayem principal investigator
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 Therapeutic play program in people with Intellectual Disability and Intellectual Disability, Mild, 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 2 inclusion and 1 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 18 Nov 2025. 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 Stanford-Binet Scale, the fifth edition (SB-5) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 18 Nov 2025.