Autism Spectrum DisorderNCT06889233
MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS
An observational study of Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- measuring cognitive functions, severity of autism , gross and fine motor skills
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Observational
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: autistic children age ranged from 5 to 12 years
Who may be able to join
- Children had been diagnosed with ASD.
- Their chronological age ranged from 5 years to 12 years.
- Intelligence quotient (IQ) ranged from 55 to 85.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
A sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- measuring cognitive functions, severity of autism , gross and fine motor skills
- Keywords
- AUTISM, ASD, RAVEN, CARS, BOT2, FINE MOTOR SKILLS, Gross motor skills
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring cognitive functions, severity of autism , gross and fine motor skillsBehavioural
measuring cognitive functions by RAVEN measuring severity by CARS measuring fine and gross motor functions by BOT2
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Behavioral: measuring cognitive functions, severity of autism , gross and fine motor skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale
Measured: 12 weeks
Secondary outcomes (1)
measuring cognitive functions by RAVEN Progressive matrices
this scale items like puzzle and the child must extract the missed part from six choices
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Ali Abdelmoniem, Cairo University
- Investigators
- Heba Kamal professor, professor of physical therapy, Study chair, Cairo UniversityAlaa fahmy hassan El Nemer, lecturer of physical therapy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889233
- Sponsor's protocol ID
- P.T.REC/012/005056
- Status last verified
- Jan 2024
- First submitted
- 27 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS
- ClinicalTrials.gov ID
- NCT06889233
- Acronym / sponsor ID
- P.T.REC/012/005056
- Conditions
- Autism Spectrum Disorder
- Keywords
- AUTISM, ASD, RAVEN, CARS, BOT2, FINE MOTOR SKILLS, Gross motor skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 21 Mar 2025 (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.
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
Detailed description
A sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | Behavioral: measuring cognitive functions, severity of autism , gross and fine motor skillsWe 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 . |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- autistic children age ranged from 5 to 12 years
Key inclusion criteria (3 listed)
- Children had been diagnosed with ASD.
- Their chronological age ranged from 5 years to 12 years.
- Intelligence quotient (IQ) ranged from 55 to 85.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| measuring cognitive functions, severity of autism , gross and fine motor skillsmeasuring cognitive functions by RAVEN measuring severity by CARS measuring fine and gross motor functions by BOT2 | Behavioural | observational group |
Primary outcome
measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale
Time frame: 12 weeks
1 secondary outcome
measuring cognitive functions by RAVEN Progressive matrices
Time frame: 12 weeks
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 21 Mar 2025.
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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.
Heba Kamal professor, professor of physical therapy study chair
Cairo University
Alaa fahmy hassan El Nemer, lecturer of physical therapy study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Cairo 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 3 inclusion and 3 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 21 Mar 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?
measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale (time frame: 12 weeks). 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 21 Mar 2025.