NCT06735482

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

December 11, 2024

Last Update Submit

November 17, 2025

Conditions

Keywords

PlayPlay therapyTherapeutic playMotor Adaptive BehaviorAdaptive BehaviorIntellectual Disability

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    8 weeks

Study Arms (2)

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.

Behavioral: Therapeutic play program

Group B control

NO INTERVENTION

Children will not receive any intervention

Interventions

Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills.

Also known as: play therapy program
Group A Experimental

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Conditions

Intellectual DisabilityLymphoma, FollicularLearning DisabilitiesPsychomotor Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCommunication Disorders

Study Officials

  • Tayseer S Abdeldayem

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor is blinded for the assessed children's allocation in groups. in both preprogram and postprogram assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

December 15, 2024

Primary Completion

March 30, 2025

Study Completion

April 15, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations