- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07656961
Ayres Sensory Integration Test Evaluation Results and Neurodevelopmentally Focused Counseling in Children With Neurodevelopmental Problems
Study Overview
Status
Detailed Description
After application to the YUGEM Sensory Perception Motor Unit, the child and family will undergo a preliminary assessment. Following the necessary interviews and psychiatric consultation, specialists will decide whether the child is suitable for the Evaluation in Ayres Sensory Integration (EASI).
Children who are considered suitable for the EASI assessment will be evaluated through a multidisciplinary approach. The data obtained from the assessment will be analyzed using computer-based statistical software, and the results will be reviewed by the specialists. Based on these results, the frequency, duration, and delivery method of sensory integration therapy will be determined according to the needs of the child and family.
Neurodevelopmentally focused therapy counseling based on Ayres Sensory Integration principles will be planned either face-to-face or remotely, as appropriate for the child and family. After this decision, a meeting will be held with the family to plan the child's therapy process. There will be a 6-month therapy-counseling process.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elif Develi, PhD
- Phone Number: +90 555 593 62 93
- Email: elifstn@yahoo.com
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey (Türkiye), 34755
- Yeditepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 3-12
- Sensory sensitivity (excessive or under-reaction to tactile, movement, auditory, or visual stimuli)
- Have been referred by a pediatrician for neurodevelopmental monitoring
- Have coordination difficulties
- Difficulty organizing gross and/or fine motor movements
- Activity level significantly above or below the norm for their age
- Delays in academic achievement
- Difficulties with daily living skills such as dressing and personal hygiene
Exclusion Criteria:
- Being under 3 years of age or over 12 years of age
- Having no conditions that fall outside normal developmental parameters
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children With Neurodevelopmental Disorders
Children aged 3 to 12 years with neurodevelopmental disorders who applied to the YUGEM Sensory Perception Motor Unit and are considered suitable for the Evaluation in Ayres Sensory Integration assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Evaluation of Ayres Sensory Integration (EASI)
Time Frame: 4 Weeks
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The Evaluation of Ayres Sensory Intergation test measures sensory perception, postural/ocular/bilateral motor integration, praxis, and sensory reactivity in a way that minimizes the effects of culture, language comprehension, and prior experience.
The EASI tests are designed for children aged 3-12 and will be administered by appropriately trained professionals.
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4 Weeks
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Pediatric Sensory Profile
Time Frame: 4 weeks
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This is a measure consisting of three main sections used in children.
These are; sensory processing, modulation and behavioral and emotional responses.
The subgroups of each main section (14 sections in total, 125 questions) are tested.
This scale is administered by the caregiver.
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 125 (Norgine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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