- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06735482
Therapeutic Play in Children With Mild Intellectual Disability
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beni Suweif Governorate
-
Banī Suwayf, Beni Suweif Governorate, Egypt, 62521
- Beni-Suef University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A 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. |
Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills.
Other Names:
|
|
No Intervention: Group B control
Children will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
8 weeks
|
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tayseer S Abdeldayem, 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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neurobehavioral Manifestations
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neurodevelopmental Disorders
- Lymphoma
- Communication Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Lymphoma, Follicular
- Intellectual Disability
- Learning Disabilities
- Psychomotor Disorders
Other Study ID Numbers
- FPTBSUREC/0903/241124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Intellectual Disability
-
Oasi Research Institute-IRCCSNot yet recruitingMild Intellectual DisabilityItaly
-
GalenusRx, Inc.CP UnlimitedNot yet recruitingDevelopmental Disability | Intellectual Disability, Mild | Intellectual Disability, Mild to ModerateUnited States
-
Oasi Research Institute-IRCCSNot yet recruiting
-
Oasi Research Institute-IRCCSNot yet recruitingMild Intellectual DisabilityItaly
-
Oasi Research Institute-IRCCSNot yet recruiting
-
University of ExtremaduraUniversity of CadizCompletedDisability Physical | Disabilities Multiple | Disability, Intellectual | Disability Hearing | Disability, VisionSpain
-
Temple UniversityUniversity of Florida; University of Minnesota; University of New HampshireNot yet recruitingDevelopmental Disability | Intellectual Disability, Mild to ModerateUnited States
-
University of California, San FranciscoKorea Health Industry Development Institute; DoBrain Inc.CompletedMild Intellectual Disability | Borderline Intellectual FunctioningUnited States
-
KoraalUniversity of Amsterdam; Zuyd University of Applied SciencesCompletedMild Intellectual Disability | Borderline Intellectual FunctioningNetherlands
-
Vestvagoy MunicipalityUniversity of Oslo; University of TromsoActive, not recruitingDisability, Developmental | Disabilities, IntellectualNorway
Clinical Trials on Therapeutic play program
-
Eskisehir Osmangazi UniversityRecruiting
-
Aydin Adnan Menderes UniversityCompletedAnxiety | FearTurkey
-
Maltepe UniversityCompleted
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Nationwide Children's HospitalNational Cancer Institute (NCI)RecruitingChildhood CancerUnited States
-
Vanderbilt University Medical CenterCompleted
-
San Diego State UniversityNational Heart, Lung, and Blood Institute (NHLBI); Boys and Girls Clubs of...Enrolling by invitation
-
The Catholic University of KoreaCompleted
-
Vanderbilt UniversityCompletedViolence PreventionUnited States
-
Vanderbilt UniversityVanderbilt University Medical CenterCompleted