NCT05900830

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

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 Nov 2022

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

Study Start

First participant enrolled

November 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

February 10, 2023

Last Update Submit

November 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months

Secondary Outcomes (1)

  • The Stanford-Binet Scale, the fifth edition

    2 months

Study Arms (2)

common educational methods

ACTIVE COMPARATOR

this group will receive common educational methods

Other: common educational methods

play based program

EXPERIMENTAL

this group will get the combined selected physical and occupational therapy program

Other: play therapy

Interventions

A combined program based on physical and occupational therapy techniques within a play context

Also known as: physical and occupational therapy program
play based program

the child will receive his education in a passive manner

Also known as: Passive class room education
common educational methods

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

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
  • Children of parents who refuse to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tayseer Younes

Cairo, Cairo Governorate, 11411, Egypt

Location

MeSH Terms

Conditions

Intellectual DisabilityLymphoma, Follicular

Interventions

Play TherapyRestraint, Physical

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 Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesBehavior ControlImmobilizationInvestigative Techniques

Study Officials

  • Zienab M Mahmoud, PhD

    Beni-Suef University

    STUDY CHAIR
  • Nahed MG Makary, PhD

    Beni-Suef University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 10, 2023

First Posted

June 13, 2023

Study Start

November 15, 2022

Primary Completion

January 30, 2023

Study Completion

February 5, 2023

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

no personal data will be shared

Locations