Sensory Integration DysfunctionNCT05260502
The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.
An observational study of Sensory Integration Dysfunction, run by Assiut University.
Trial summary
The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Integration Dysfunction
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Dec 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Both males and females were included. Age ranges from 6- 18 years.
Who may be able to join
None listed.
Who cannot join
- .Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship Between Brain Volume and Sensory Integration in Children and Adolescence With Attention Deficit Hyperactivity Disorder and Autistic Spectrum Disorder.
The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study
Read the detailed description
Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.
- Conditions
- Sensory Integration Dysfunction
- Keywords
- sensory disintegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autistic children | magnetic resonance imaging brain for autistic children | |
| attention deficit hyperactivity disorder children | magnetic resonance imaging brain for attention deficit hyperactivity disorder children | |
| Normal children | magnetic resonance imaging brain for Normal children |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory disintegration in neurodevelopmental disorders
Estimate the prevalence of sensory disintegration problems among study groups and differentiate the pattern of sensory disintegration problems among study groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sensory Integration DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Moheb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260502
- Sponsor's protocol ID
- Trbbvas
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gourley L, Wind C, Henninger EM, Chinitz S. Sensory Processing Difficulties, Behavioral Problems, and Parental Stress in a Clinical Population of Young Children. J Child Fam Stud. 2013 Oct 1;22(7):912-921. doi: 10.1007/s10826-012-9650-9.
PubMed 24443636Al-Heizan MO, AlAbdulwahab SS, Kachanathu SJ, Natho M. Sensory processing dysfunction among Saudi children with and without autism. J Phys Ther Sci. 2015 May;27(5):1313-6. doi: 10.1589/jpts.27.1313. Epub 2015 May 26.
PubMed 26157208Schaaf RC, Lane AE. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD. J Autism Dev Disord. 2015 May;45(5):1380-95. doi: 10.1007/s10803-014-2299-z.
PubMed 25374136
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Brain Volume and Sensory Integration in Children and Adolescence With Attention Deficit Hyperactivity Disorder and Autistic Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT05260502
- Acronym / sponsor ID
- Trbbvas
- Conditions
- Sensory Integration Dysfunction
- Keywords
- sensory disintegration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (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.
The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study
Detailed description
Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autistic children | – | –magnetic resonance imaging brain for autistic children |
| attention deficit hyperactivity disorder children | – | –magnetic resonance imaging brain for attention deficit hyperactivity disorder children |
| Normal children | – | –magnetic resonance imaging brain for Normal children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Both males and females were included. Age ranges from 6- 18 years.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- .Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensory disintegration in neurodevelopmental disorders
Time frame: 2 years
Estimate the prevalence of sensory disintegration problems among study groups and differentiate the pattern of sensory disintegration problems among study groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 24443636Gourley L, Wind C, Henninger EM, Chinitz S. Sensory Processing Difficulties, Behavioral Problems, and Parental Stress in a Clinical Population of Young Children. J Child Fam Stud. 2013 Oct 1;22(7):912-921. doi: 10.1007/s10826-012-9650-9.
- Background: PubMed 26157208Al-Heizan MO, AlAbdulwahab SS, Kachanathu SJ, Natho M. Sensory processing dysfunction among Saudi children with and without autism. J Phys Ther Sci. 2015 May;27(5):1313-6. doi: 10.1589/jpts.27.1313. Epub 2015 May 26.
- Background: PubMed 25374136Schaaf RC, Lane AE. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD. J Autism Dev Disord. 2015 May;45(5):1380-95. doi: 10.1007/s10803-014-2299-z.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Integration Dysfunction, run by Assiut University.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Mohammed Moheb, assistant lecturer (01064093337, amiramoheb1992@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory disintegration in neurodevelopmental disorders (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260502, which also lists 3 linked publications.
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 2 Mar 2022.