NCT06889233

Brief Summary

To investigate the relationship between cognitive function, the severity of autism spectrum disorder (ASD), and the development of fine and gross motor skills in children with ASD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

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

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

February 27, 2025

Last Update Submit

March 16, 2025

Conditions

Keywords

AUTISMASDRAVENCARSBOT2FINE MOTOR SKILLSGross motor skills

Outcome Measures

Primary Outcomes (1)

  • measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale

    12 weeks

Secondary Outcomes (1)

  • measuring cognitive functions by RAVEN Progressive matrices

    12 weeks

Other Outcomes (1)

  • measuring severity of autism by using CARS scale

    12 weeks

Study Arms (1)

observational group

We will assess cognitive function using the Raven's Progressive Matrices and measure the severity of autism using the Childhood Autism Rating Scale (CARS). These assessments will then be compared with the children's fine and gross motor abilities using BOT2 .

Behavioral: measuring cognitive functions, severity of autism , gross and fine motor skills

Interventions

measuring cognitive functions by RAVEN measuring severity by CARS measuring fine and gross motor functions by BOT2

observational group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

autistic children age ranged from 5 to 12 years

You may qualify if:

  • Children had been diagnosed with ASD.
  • Their chronological age ranged from 5 years to 12 years.
  • Intelligence quotient (IQ) ranged from 55 to 85.

You may not qualify if:

  • Any child with the following criteria would be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:
  • The child with ASD and other motor disabilities.
  • Visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Cairo, Dokki, 12613, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Heba Kamal professor, professor of physical therapy

    Cairo University

    STUDY CHAIR
  • Alaa fahmy hassan El Nemer, lecturer of physical therapy

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physiotherapist

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 21, 2025

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

March 21, 2025

Record last verified: 2024-01

Locations